U.S. patent application number 13/541604 was filed with the patent office on 2012-11-01 for nutritive compositions and methods of using same.
This patent application is currently assigned to Pentec Health, Inc.. Invention is credited to Eileen Moore.
Application Number | 20120277170 13/541604 |
Document ID | / |
Family ID | 44226741 |
Filed Date | 2012-11-01 |
United States Patent
Application |
20120277170 |
Kind Code |
A1 |
Moore; Eileen |
November 1, 2012 |
NUTRITIVE COMPOSITIONS AND METHODS OF USING SAME
Abstract
The invention provides intradialytic parenteral nutrition (IDPN)
compositions with low carbohydrate for the treatment of
malnutrition in dialysis subjects. In some embodiments, the IDPN
compositions are advantageous for the treatment of malnutrition in
subjects who are diabetic or suffer from other glucose management
related pathologies or subjects who benefit from strict fluid
management.
Inventors: |
Moore; Eileen; (Parma,
OH) |
Assignee: |
Pentec Health, Inc.
Boothwyn
PA
|
Family ID: |
44226741 |
Appl. No.: |
13/541604 |
Filed: |
July 3, 2012 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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PCT/US2010/003192 |
Dec 15, 2010 |
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13541604 |
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61292139 |
Jan 4, 2010 |
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61292806 |
Jan 6, 2010 |
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Current U.S.
Class: |
514/23 ;
514/400 |
Current CPC
Class: |
A61K 31/405 20130101;
A61P 43/00 20180101; A61P 7/08 20180101; A61K 31/198 20130101; A61P
3/10 20180101; A61K 31/20 20130101; A61P 3/02 20180101; A61P 3/08
20180101; A61K 31/7004 20130101; A61K 31/401 20130101; A61K 45/06
20130101; A61K 31/198 20130101; A61K 2300/00 20130101; A61K 31/20
20130101; A61K 2300/00 20130101; A61K 31/7004 20130101; A61K
2300/00 20130101 |
Class at
Publication: |
514/23 ;
514/400 |
International
Class: |
A61K 31/7004 20060101
A61K031/7004; A61P 3/02 20060101 A61P003/02; A61P 3/08 20060101
A61P003/08; A61K 31/4172 20060101 A61K031/4172 |
Claims
1-111. (canceled)
112. A method for treating or preventing malnutrition in a
hemodialysis subject in need thereof, the method comprising
formulating an aqueous composition comprising between 0 and 10%
mass/volume of dextrose; 7 to 20% mass/volume of amino acids; and
less than 5% mass/volume of lipids based on a body mass measurement
of the subject, and parenterally administering the composition in
conjunction with the hemodialysis.
113. The method of claim 112, wherein at least 18% of the amino
acids are branched-chain amino acids.
114. The method of claim 112, wherein the amino acids comprise
seventeen amino acids.
115. The method of claim 114, wherein the seventeen amino acids are
lysine, leucine, phenylalanine, valine, histidine, isoleucine,
methionine, threonine, tryptophan, alanine, arginine, glycine,
proline, glutamic acid, serine, aspartic acid, and tyrosine.
116. The method of claim 112, wherein the composition is lipid
free.
117. The method of claim 112, wherein the composition is
carbohydrate-free.
118. The method of claim 112, wherein the composition comprises
between 1 and 10% mass/volume of dextrose based on the body mass
measurement of the subject, wherein the dextrose, the amino acids,
and the lipids are in the same composition, wherein the composition
is stable for at least 24 hours.
119. The method of claim 118, wherein the composition comprises
between 2 and 7% dextrose and between 9 and 16% amino acids.
120. The method of claim 112, wherein the composition further
comprises micronutrients.
121. The method of claim 112, wherein the composition is less than
430 mL in volume.
122. The method of claim 112, wherein the composition is contained
within a sterile container suitable for parenteral administration
of the composition.
123. The method of claim 112, wherein the formulating is further
based on a duration of the hemodialysis.
124. The method of claim 123, wherein the duration of the
hemodialysis is between 2 to 4.5 hrs.
125. The method of claim 123, wherein the duration is based on the
body mass measurement of the subject.
126. The method of claim 112, wherein the subject's albumin levels
increase by 0.1 g/deciliter within three months after a first
administration of the composition.
127. The method of claim 112, wherein treating the malnutrition
comprises raising the subject's albumin levels to at least about
3.8 g/dL.
128. The method of claim 112, wherein the treating or preventing
malnutrition comprises modulating blood glucose levels of the
subject.
129. The method of claim 112, wherein the subject has a
post-hemodialysis blood glucose level that is within 20% of the
subject's pre-hemodialysis blood glucose level.
130. The method of claim 112, wherein the subject has reduced side
effects associated with infusion of the composition during
hemodialysis.
131. The method of claim 112, wherein the subject has reduced
occurrence of hyperglycemia during hemodialysis.
132. The method of claim 112, wherein the subject has reduced fluid
accumulation during hemodialysis.
133. The method of claim 112, wherein the subject has diabetes.
134. The method of claim 112, wherein the subject has a body mass
less than 34 kg.
135. The method of claim 112, wherein the composition is introduced
into a hemodialysis machine by a venous drip chamber.
136. The method of claim 112, wherein the subject is administered
the composition 1-5 times per week.
137. The method of claim 112, wherein the subject is from about 1
to about 18 years old.
138. A method of treating or preventing malnutrition in a pediatric
hemodialysis subject, the method comprising parenterally
administering a sterile aqueous composition to the subject, the
composition comprising: an amount of dextrose from about 4 g to
about 19 g and an amount of amino acids from about 13.5 g to about
42 g in a total volume of about 124 mL to about 357 mL, wherein the
subject has a body mass of from 9 kg to 33 kg, wherein the
administering is done at an infusion rate of from 17 mL/hour to 127
mL/hour, wherein the dextrose and the amino acids are in the same
composition, wherein the composition is stable for at least 24
hours.
139. A method of treating or preventing malnutrition in a
hemodialysis subject, the method comprising parenterally
administering a sterile aqueous composition to the subject, the
composition comprising: an amount of dextrose from about 17 g to
about 47 g and an amount of amino acids from about 51 g to about
105 g in a total volume of about 329 mL to about 817 mL, wherein
the subject has a body mass of from 34 kg to at least 70 kg,
wherein the administering is done at an infusion rate of from 45
mL/hour to 290 mL/hour, wherein the dextrose and the amino acids
are in the same composition, wherein the composition is stable for
at least 24 hours.
140. A method of treating or preventing malnutrition in a
hemodialysis subject, the method comprising parenterally
administering a sterile aqueous composition to the subject, the
composition comprising: an amount of dextrose from about 17 g to
about 47 g, an amount of amino acids from about 51 g to about 105
g, and an amount of lipids from about 8.6 g to about 24 g in a
total volume of about 372 mL to about 937 mL, wherein the subject
has a body mass of at least 34 kg, wherein the administering is
done at an infusion rate of from 45 mL/hour to 325 mL/hour, wherein
the dextrose, the amino acids, and the lipids are in the same
composition, wherein the composition is stable for at least 24
hours.
141. A sterile aqueous composition for parenteral administration
comprising: a) between 2 and 26 g of dextrose; and b) between 12
and 45 g of amino acids, wherein the amino acids comprise more than
18% branched amino acids; wherein the composition is dosage form
having a volume less than 450 mL, wherein the dextrose and the
amino acids are in the same composition, wherein the composition is
stable for at least 24 hours.
142. The composition of claim 141, wherein the amino acids comprise
seventeen amino acids.
143. The composition of claim 142, wherein the seventeen amino
acids are lysine, leucine, phenylalanine, valine, histidine,
isoleucine, methionine, threonine, tryptophan, alanine, arginine,
glycine, proline, glutamic acid, serine, aspartic acid, and
tyrosine.
144. The composition of claim 141, wherein the composition is lipid
free.
145. The composition of claim 141, further comprising lipids.
146. The composition of claim 145, wherein the lipids are present
in the composition in an amount between 8 and 25 g of lipids.
147. The composition of claim 145, wherein the lipids are present
in the composition in an amount less than 5% mass/volume.
148. The composition of claim 145, wherein the lipids are present
in the composition in an amount between 5 to 30% mass/volume.
149. The composition of claim 141, further comprising
micronutrients.
150. The composition of claim 141, wherein the composition is
contained within a sterile container suitable for parenteral
administration of the composition.
151. A sterile aqueous composition for parenteral administration
comprising: a) less than 0.1 g/mL of dextrose; and b) between 12
and 45 g of amino acids, wherein the composition has a volume less
than 450 mL, wherein the dextrose and the amino acids are in the
same composition, wherein the composition is stable for at least 24
hours.
152. The composition of claim 151, wherein the composition is lipid
free.
153. The composition of claim 151, further comprising between 8 and
25 g of lipids.
154. The composition of claim 151, wherein the amino acids comprise
more than 18% branched amino acids.
155. A sterile aqueous composition for parenteral administration
comprising: a) between 2 and 26 g of dextrose; b) between 12 and 45
g of amino acids, wherein the amino acids comprise more than 18%
branched amino acids; and c) between 8 and 25 g of lipids, wherein
the dextrose, the amino acids, and the lipids are in the same
composition, wherein the composition is stable for at least 24
hours.
Description
[0001] This application claims priority to U.S. Provisional App.
No. 61/292,139, filed on Jan. 4, 2010, and U.S. Provisional App.
No. 61/292,806, filed on Jan. 6, 2010. Each of the above
applications is incorporated by reference herein in its
entirety.
FIELD OF THE INVENTION
[0002] The invention provides nutrition supplement compositions for
subjects receiving dialysis treatment and methods of using the
nutrition supplement compositions. In some embodiments the
nutrition supplement compositions comprise reduced levels of
carbohydrates and lower volume to reduce complications in subjects.
In some cases, the subjects are diabetic or suffer from other
glucose management related pathologies, or subjects benefit from
strict fluid management.
BACKGROUND OF THE INVENTION
[0003] Severe malnutrition remains a problem for subjects receiving
maintenance hemodialysis (MHD). Dialysis subjects often have poor
appetites and low energy. This malnutrition is reflected in low
serum albumin concentrations, a strong predictor of increased
morbidity and mortality. (Moore and Lindenfield, Support Line
29(5):7-16 (October 2007)). Subjects are often treated using diet
liberalization, oral supplements and enteral feeding. When these
methods are not effective intradialytic parenteral nutrition (IDPN)
can be utilized for more aggressive nutrition repletion
efforts.
[0004] IDPN is infused during the hemodialysis procedure. IDPN has
been used for decades and has resulted in weight gain and improved
protein levels in subjects. (U.S. Publication No. 2005/0148647).
During IDPN infusion into a subject, the subject's blood glucose
must be monitored to avoid problems, such as hyperglycemia and
hypoglycemia. Serum bicarbonate and carbon dioxide levels must also
be monitored to check for acidosis caused by administration of
amino acids.
[0005] IDPN is usually administered in one liter of solution, and
occasionally micronutrients, like vitamins and minerals are
co-administered in or with IDPN. Literature suggests that IDPN is
effective in decreasing morbidity and mortality in hemodialysis
(MHD) subjects, leads to increased levels of serum albumin and
creatinine levels, and increased body weight. (Moore and Celano,
Nutrition in Clinical Practice, 20(2):202-212 (2005)). Hypoglycemia
is another potential dangerous result of the administration of
insulin during IDPN with symptoms of nervousness, sweating, intense
hunger, trembling, weakness, palpitations, and trouble
speaking.
[0006] Problems associated with IDPN include hyperglycemia,
complications in subjects with insulin resistance or other problems
associated with glucose management, as well as complications in
subjects who require strict fluid management. The glucose
concentrations administered with IDPN can cause hyperglycemia and
hypoglycemia in some subjects. The administration of insulin can
sometimes successfully treat this hyperglycemia, but some subjects
demonstrate insulin resistance, and might not respond to insulin
treatment. (Goldstein and Strom, Journal of Renal Nutrition
1(1):9-22 (January 1991)). Hyperglycemia is a major barrier to
effective nutrition support even outside the context of
hemodialysis. Many studies report associations between
hyperglycemia and increased morbidity and mortality. (McCowen and
Bistrian, Nutrition in Clinical Practice, 19(3):235-244 (June
2004)). Moreover, the amount of fluid in typical IDPN treatment is
a barrier to use in subjects with strict fluid management.
SUMMARY OF THE INVENTION
[0007] In one aspect the invention provides a sterile aqueous
composition for parenteral administration comprising between 2 and
26 g of dextrose; and between 12 and 45 g of amino acids; wherein
the dosage form is an aqueous composition has a volume less than
450 mL.
[0008] In another aspect the invention provides a sterile aqueous
composition for parenteral administration comprising between 2 and
26 g of dextrose; between 12 and 45 g of amino acids; and between 8
and 25 g of lipids. In one embodiment the amino acids comprise
seventeen amino acids. In another embodiment the seventeen amino
acids are lysine, leucine, phenylalanine, valine, histidine,
isoleucine, methionine, threonine, tryptophan, alanine, arginine,
glycine, proline, glutamic acid, serine, aspartic acid, and
tyrosine. In another embodiment an aqueous composition further
comprises lipids. In another embodiment the lipids are present in
the aqueous composition in an amount between 5 to 30% mass/volume.
In another embodiment the lipids are present in the aqueous
composition in an amount less than 5% mass/volume. In another
embodiment the lipids are present in the aqueous composition in an
amount between 5 to 30% mass/volume. In another embodiment the
lipids are present in the aqueous composition in an amount less
than 5% mass/volume. In another embodiment an aqueous composition
further comprises micronutrients. In another embodiment the
composition is contained within a sterile container suitable for
parenteral administration of the aqueous composition.
[0009] In another aspect the invention provides a method for
treating or preventing malnutrition in a hemodialysis subject in
need thereof comprising formulating an aqueous composition
comprising between 0 and 10% mass/volume of dextrose and 7 to 20%
mass/volume of amino acids based on a body mass measurement of the
subject and, optionally, the intended duration of the hemodialysis
and parenterally administering said aqueous composition in
conjunction with the hemodialysis. In another embodiment, the
composition further comprises lipids. In another embodiment, the
composition is lipid free. In another embodiment, the composition
is carbohydrate free. In one embodiment the method comprises
raising said subject's albumin levels by 0.2-0.4 g/dL in 1 to 3
months. In another embodiment the method comprises raising said
subject's albumin levels by 0.2-0.4 g/dL in 1 to 6 months. In
another embodiment the method comprises raising said subject's
albumin levels by 0.2-0.4 g/dL in 1 to 12 months. In another
embodiment embodiment the method comprises raising said subject's
albumin levels by 0.2-0.4 g/dL in 1 to 3 years. In another
embodiment the method comprises raising said subject's albumin
levels by 0.2-0.4 g/dL in 1 to 5 years. In another embodiment the
method comprises raising said subject's albumin levels by 0.2-0.4
g/dL in 1 to 10 years. In another embodiment treating the
malnutrition comprises raising said subject's albumin levels to at
least about 3.8 g/dL. In another embodiment the aqueous composition
comprises between 2 and 7% dextrose and between 9 and 16% amino
acids. In another embodiment the aqueous composition lacks lipids.
In another embodiment the aqueous composition comprises lipids. In
another embodiment hemodialysis is performed with a Fresenius 2008
series, a B.Braun Dialog+, a Gambro Phoenix System, a Redy 2000, a
Baxter SPS550/1550, an Althin 1000, an Althin Altratouch 1000, an
Althin Tina, a Meridian, an Aurora system 1000, a NxStage System,
or a Fresinius 2008K dialysis machine. In another embodiment the
aqueous composition is introduced into a hemodialysis machine by a
venous drip chamber. In another embodiment the subject is
administered said aqueous composition 1-5 times per week. In
another embodiment the subject is administered said aqueous
composition each time said subject undergoes dialysis for 1-3
months. In another embodiment the subject is administered said
aqueous composition each time said subject undergoes dialysis for
1-6 months. In another embodiment the subject is administered said
aqueous composition each time said subject undergoes dialysis for
1-12 months. In another embodiment the subject is administered said
aqueous composition each time said subject undergoes dialysis for
1-3 years. In another embodiment the subject is administered said
aqueous composition each time said subject undergoes dialysis for
1-5 years. In another embodiment the subject is administered said
aqueous composition each time said subject undergoes dialysis for
1-10 years. In another embodiment the subject's albumin levels
increase by 0.2 g/deciliter within three months after the first
administration of said composition. In another embodiment the
subject's albumin levels increase by 0.4 g/deciliter within three
months after the first administration of said composition. In
another embodiment the subject is a child. In another embodiment
the subject is under about 8 years old. In another embodiment the
subject is under about 12 years old. In another embodiment the
subject is from about 1 to about 18 years old. In another
embodiment the subject is from about 5 to about 12 years old. In
another embodiment the composition comprises less than 430 mls in
volume. In another embodiment the subject is older than 18 years
old. In another embodiment the subject has reduced side effects
associated with infusion of an aqueous composition during
hemodialysis. In another embodiment the side effects are dyspnea,
increased respiratory rate, rhonchi, edema, hypertension, hernia,
or anxiety. In another embodiment the subject has reduced
occurrence of hyperglycemia during hemodialysis. In another
embodiment the subject has reduced fluid accumulation during
dialysis. In another embodiment the subject has diabetes. In
another embodiment, the subject experiences higher nutrient
absorption than a subject being administered a higher-volume
composition. In another embodiment, the subject has reduced fluid
accumulation during hemodialysis. In another embodiment, the
subject accumulates less than 3 liter of fluid during hemodialysis.
In another embodiment, the subject accumulates less than 2 liter of
fluid during hemodialysis. In another embodiment, the subject
accumulates less than 1 liter of fluid during hemodialysis. In
another embodiment, the subject accumulates less than 500 ml of
fluid during hemodialysis. In another embodiment, the subject
accumulates about 0-3 liter of fluid during hemodialysis. In
another embodiment, the subject has a lower fluid weight
post-hemodialysis then pre-hemodialysis. In another embodiment, the
subject loses less than 100 ml of fluid during hemodialysis. In
another embodiment, the subject loses less than 250 ml of fluid
during hemodialysis. In another embodiment, the subject loses less
than 500 ml of fluid during hemodialysis. In another embodiment,
the subject loses less than 1 liter of fluid during hemodialysis.
In another embodiment, the subject loses between 0-1 liter of fluid
during hemodialysis. In another embodiment, the subject loses
between 0-1.5 liters of fluid during hemodialysis. In another
embodiment, the subject loses between 0-2 liters of fluid during
hemodialysis. In another embodiment, the subject loses between 0-3
liters of fluid during hemodialysis. In another embodiment, the
subject loses between 0-4 liters of fluid during hemodialysis. In
another embodiment, the subject loses between 0-5 liters of fluid
during hemodialysis. In another embodiment, the subject completes
the hemodialysis without extra fluid weight. In another embodiment,
the subject has a total weight post-hemodialysis that is about the
same as the subject's weight pre-hemodialysis. In another
embodiment, the subject has a total weight post-hemodialysis that
is within 1-20% of the subject's pre-hemodialysis total weight. In
another embodiment, the subject has a total weight
post-hemodialysis that is within 1-15% of the subject's
pre-hemodialysis total weight. In another embodiment, the subject
has a total weight post-hemodialysis that is within 1-10% of the
subject's pre-hemodialysis total weight. In another embodiment, the
subject has a total weight post-hemodialysis that is within 1-5% of
the subject's pre-hemodialysis total weight. In another embodiment,
the subject has a total weight post-hemodialysis that is within
about 1, 2, 3, 4, 5, 6, 7, 8, 9 or 10% of the subject's
pre-hemodialysis total weight. In another embodiment, the subject
has a post-hemodialysis blood glucose level that is within 1-25% of
the subject's pre-hemodialysis blood glucose level. In another
embodiment, the subject has a post-hemodialysis blood glucose level
that is within 1-30% of the subject's pre-hemodialysis blood
glucose level. In another embodiment, the subject has a
post-hemodialysis blood glucose level that is within 1-15% of the
subject's pre-hemodialysis blood glucose level. In another
embodiment, the subject has a post-hemodialysis blood glucose level
that is within 1-10% of the subject's pre-hemodialysis blood
glucose level. In another embodiment, the subject has a
post-hemodialysis blood glucose level that is within 1-5% of the
subject's pre-hemodialysis blood glucose level. In another
embodiment, the subject has a post-hemodialysis blood glucose level
that is within 10% of their pre-hemodialysis blood glucose level.
In another embodiment, the subject has a post-hemodialysis blood
glucose level that is within 5% of the subject's pre-hemodialysis
blood glucose level. In another embodiment, the subject has a
post-hemodialysis blood glucose level that is within about 1, 2, 3,
4, 5, 6, 7, 8, 9 or 10% of the subject's pre-hemodialysis blood
glucose level. In another embodiment, the hemodialyis moduylates
the blood glucose levels of the subject. In another embodiment, the
hemodialyis moduylates the blood glucose levels of the subject. In
another embodiment, the subject's blood glucose levels vary less
than 30% during-hemodialysis. In another embodiment, the subject's
blood glucose levels vary less than 30% pre-, mid-, and
post-hemodialysis. In another embodiment, the subject's blood
glucose levels vary less than 25% during-hemodialysis. In another
embodiment, the subject's blood glucose levels vary less than 25%
pre-, mid-, and post-hemodialysis. In another embodiment, the
subject's blood glucose levels vary less than 20%
during-hemodialysis. In another embodiment, the subject's blood
glucose levels vary less than 20% pre-, mid-, and
post-hemodialysis. In another embodiment, the subject's blood
glucose levels vary less than 15% during-hemodialysis. In another
embodiment, the subject's blood glucose levels vary less than 15%
pre-, mid-, and post-hemodialysis. In another embodiment, the
subject's blood glucose levels vary less than 10%
during-hemodialysis. In another embodiment, the subject's blood
glucose levels vary less than 10% pre-, mid-, and
post-hemodialysis. In another embodiment, the subject's blood
glucose levels vary less than 5% during-hemodialysis. In another
embodiment, the subject's blood glucose levels vary less than 5%
pre-, mid-, and post-hemodialysis. In another embodiment, the
subject's blood glucose levels vary less than 1, 2, 3, 4, 5, 6, 7,
8, 9, or 10% during-hemodialysis. In another embodiment, the
subject's blood glucose levels vary less than 0-10% pre-, mid-, and
post-hemodialysis. In another embodiment, the subject's blood
glucose levels decrease during dialysis. In another embodiment, the
subject's post-hemodialysis blood glucose levels decrease by at
least 20% as compared to the subject's pre-hemodialysis glucose
levels. In another embodiment, the subject's post-hemodialysis
blood glucose levels decrease by at least 15% as compared to the
subject's pre-hemodialysis glucose levels. In another embodiment,
the subject's post-hemodialysis blood glucose levels decrease by at
least 10% as compared to the subject's pre-hemodialysis glucose
levels. In another embodiment, the subject's post-hemodialysis
blood glucose levels decrease by at least 5% as compared to the
subject's pre-hemodialysis glucose levels. In another embodiment,
the subject's post-hemodialysis blood glucose levels decrease by at
least 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10% as compared to the
subject's pre-hemodialysis glucose levels. In another embodiment,
the subject's post-hemodialysis blood glucose levels decrease by at
least 2% as compared to the subject's pre-hemodialysis glucose
levels. In another embodiment, the subject's post-hemodialysis
blood glucose levels decrease by 0-10% as compared to the subject's
pre-hemodialysis glucose levels. In another embodiment, the
subject's post-hemodialysis blood glucose levels decrease by 0-5%
as compared to the subject's pre-hemodialysis glucose levels.
[0010] In another aspect, the invention provides a method for
treating or preventing malnutrition in a hemodialysis subject in
need thereof comprising formulating an aqueous composition
comprising between 0 to 10% mass/volume of dextrose, 7 to 20%
mass/volume of amino acids and less than 5% mass/volume of lipids
based on a body mass measurement of the subject and parenterally
administering said aqueous composition in conjunction with the
hemodialysis.
[0011] In another aspect, the invention provides a method for
treating or preventing malnutrition in a hemodialysis pediatric
subject in need thereof comprising formulating an aqueous
composition comprising between 1 and 10% mass/volume of dextrose
and 7 to 20% mass/volume of amino acids based on a body mass
measurement of the subject and parenterally administering said
aqueous composition in conjunction with the hemodialysis. In
another embodiment the subject has a body mass less than 34 kg.
[0012] In another aspect, the invention provides a method of
treating or preventing malnutrition in a pediatric hemodialysis
subject, the method comprising parenterally administering a sterile
aqueous composition to the subject, the composition comprising: an
amount of dextrose from about 4 g to about 19 g and an amount of
amino acids from about 13.5 g to about 42 g in a total volume of
about 124 mL to about 357 mL, wherein the subject has a body mass
of from 9 kg to 33 kg, wherein the administering is done at an
infusion rate of from 17 mL/hour to 127 mL/hour.
[0013] In one embodiment, the invention provides a method of
treating or preventing malnutrition in a subject, the method
comprising parenterally administering a sterile aqueous composition
to the subject, the composition comprising: an amount of dextrose
from about 17 g to about 47 g and an amount of amino acids from
about 51 g to about 105 g in a total volume of about 329 mL to
about 817 mL, wherein the subject has a body mass of from 34 kg to
at least 70 kg, wherein the administering is done at an infusion
rate of from 45 mL/hour to 290 mL/hour.
[0014] In another aspect, the invention provides a method of
treating or preventing malnutrition in a hemodialysis subject, the
method comprising parenterally administering a sterile aqueous
composition to the subject, the composition comprising: an amount
of dextrose from about 17 g to about 47 g, an amount of amino acids
from about 51 g to about 105 g, and an amount of lipids from 8.6 g
about to about 24 in a total volume of about 372 mL to about 937
mL, wherein the subject has a body mass of at least 34 kg, wherein
the administering is done at an infusion rate of from 45 mL/hour to
325 mL/hour.
[0015] In another aspect, the invention provides a sterile aqueous
composition for parenteral administration comprising between 2 and
26 g of dextrose, and between 12 and 45 g of amino acids comprising
branched-chain amino acids, wherein the composition is dosage form
having a volume less than 450 mL. In another embodiment, the amino
acids comprise 1-50% branched amino acids. In another embodiment,
the amino acids comprise 1-40% branched amino acids. In another
embodiment, the amino acids comprise 1-30% branched amino acids. In
another embodiment, the amino acids comprise 1-20% branched amino
acids. In another embodiment, the amino acids comprise 1-18%
branched amino acids. In another embodiment, the amino acids
comprise 1-10% branched amino acids. In another embodiment, the
amino acids comprise about 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12,
13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29,
30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46,
47, 48, 49, or 50% branched amino acids. In another embodiment, the
amino acids comprise more than 50% branched amino acids. In another
embodiment, the amino acids comprise about 2.1-23 g of
branched-chain amino acids. In another embodiment, the composition
further comprises lipids. In another embodiment, the composition is
lipid free. In some embodiments, the lipids are present in the
aqueous composition in an amount between 5 to 30% mass/volume. In
certain embodiments, the lipids are present in the aqueous
composition in an amount less than 5% mass/volume. In another
embodiment, the composition further comprises micronutrients. In
another embodiment, the composition is contained within a sterile
container suitable for parenteral administration of the aqueous
composition.
[0016] In another aspect, the invention provides a sterile aqueous
composition for parenteral administration comprising between 12 and
45 g of amino acids comprising branched-chain amino acids, wherein
the composition is dosage form having a volume less than 450 mL. In
another embodiment, the amino acids comprise 1-50% branched amino
acids. In another embodiment, the amino acids comprise 1-40%
branched amino acids. In another embodiment, the amino acids
comprise 1-30% branched amino acids. In another embodiment, the
amino acids comprise 1-20% branched amino acids. In another
embodiment, the amino acids comprise 1-18% branched amino acids. In
another embodiment, the amino acids comprise 18-30% branched amino
acids. In another embodiment, the amino acids comprise 1-10%
branched amino acids. In another embodiment, the amino acids
comprise about 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15,
16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32,
33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49,
or 50% branched amino acids. In another embodiment, the amino acids
comprise more than 50% branched amino acids. In another embodiment,
the amino acids comprise about 2.1-23 g of branched-chain amino
acids. In another embodiment, the composition further comprises
lipids. In another embodiment, the composition is lipid free. In
some embodiments, the lipids are present in the aqueous composition
in an amount between 5 to 30% mass/volume. In certain embodiments,
the lipids are present in the aqueous composition in an amount less
than 5% mass/volume. In another embodiment, the composition further
comprises micronutrients. In another embodiment, the composition
further comprises between 2 and 26 g of dextrose. In another
embodiment, the composition further comprises a carbohydrate. In
another embodiment, the composition is carbohydrate free. In
another embodiment, the composition is contained within a sterile
container suitable for parenteral administration of the aqueous
composition.
[0017] In another aspect, the invention provides for a sterile
aqueous composition for parenteral administration comprising less
than 0.1 g/mL of dextrose and between 12 and 45 g of amino acids,
wherein the composition is a lipid-free dosage form having a volume
less than 450 mL. In one embodiment, the amino acids comprise
seventeen amino acids. In another embodiment, the seventeen amino
acids are lysine, leucine, phenylalanine, valine, histidine,
isoleucine, methionine, threonine, tryptophan, alanine, arginine,
glycine, proline, glutamic acid, serine, aspartic acid, and
tyrosine. In another embodiment, the composition further comprises
micronutrients. In another embodiment, the composition is dextrose
free. In another embodiment, the composition is carbohydrate free.
In another embodiment, the composition is contained within a
sterile container suitable for parenteral administration of the
aqueous composition.
[0018] In another aspect, the invention provides for a method for
treating or preventing malnutrition in a hemodialysis subject in
need thereof, the method comprising formulating an aqueous
composition comprising less than 0.1 g/mL of dextrose, and 7 to 20%
mass/volume of amino acids based on a body mass measurement of the
subject and parenterally administering said aqueous composition in
conjunction with the hemodialysis. In one embodiment, the method
comprises raising said subject's albumin levels by 0.2-0.4 g/dL in
1 to 3 months. In another embodiment, the method for treating or
preventing malnutrition comprises raising said subject's albumin
levels to at least 3.8 g/dL. In another embodiment, said subject's
albumin levels increase by 0.1 g/dL within three months after the
first administration of said composition. In another embodiment,
said subject's albumin levels increase by 0.2 g/dL within three
months after the first administration of said composition. In
another embodiment, the method for treating or preventing
malnutrition comprises raising said subject's albumin levels from
about 0.1 g/di to about 10 g/dL. In another embodiment, the method
for treating or preventing malnutrition comprises raising said
subject's albumin levels from about 0.5 g/dl to about 5 g/dL. In
another embodiment, the method for treating or preventing
malnutrition comprises raising said subject's albumin levels from
about 1 g/di to about 5 g/dL. In another embodiment, the method for
treating or preventing malnutrition comprises raising said
subject's albumin levels from about 2 g/dl to about 5 g/dL. In
another embodiment, the method for treating or preventing
malnutrition comprises raising said subject's albumin levels from
about 3 g/dl to about 5 g/dL. In another embodiment, the method for
treating or preventing malnutrition comprises raising said
subject's albumin levels from about 4 g/dl to about 10 g/dL. In
another embodiment, the method for treating or preventing
malnutrition comprises raising said subject's albumin levels from
about 5 g/dl to about 10 g/dL. In another embodiment, the method
for treating or preventing malnutrition comprises raising said
subject's albumin levels from about 3 g/dl to about 10 g/dL within
three months after the first administration of said composition. In
another embodiment, the composition is less than 450 mL in volume.
In another embodiment the subject is under about 8 years old. In
another embodiment the subject is under about 12 years old. In
another embodiment the subject is from about 1 to about 18 years
old. In another embodiment the subject is from about 5 to about 12
years old. In another embodiment the composition comprises less
than 430 mls in volume. In another embodiment the subject is older
than 18 years old. In another embodiment the subject has reduced
side effects associated with infusion of an aqueous composition
during hemodialysis. In another embodiment the side effects are
dyspnea, increased respiratory rate, rhonchi, edema, hypertension,
hernia, or anxiety. In another embodiment the subject has reduced
occurrence of hyperglycemia during hemodialysis. In another
embodiment the subject has reduced fluid accumulation during
dialysis. In another embodiment the subject has diabetes. In
another embodiment, the subject experiences higher nutrient
absorption than a subject being administered a higher-volume
composition. In another embodiment, the subject has reduced fluid
accumulation during hemodialysis. In another embodiment, the
subject accumulates less than 3 liter of fluid during hemodialysis.
In another embodiment, the subject accumulates less than 2 liter of
fluid during hemodialysis. In another embodiment, the subject
accumulates less than 1 liter of fluid during hemodialysis. In
another embodiment, the subject accumulates less than 500 ml of
fluid during hemodialysis. In another embodiment, the subject
accumulates about 0-3 liter of fluid during hemodialysis. In
another embodiment, the subject has a lower fluid weight
post-hemodialysis then pre-hemodialysis. In another embodiment, the
subject loses less than 100 ml of fluid during hemodialysis. In
another embodiment, the subject loses less than 250 ml of fluid
during hemodialysis. In another embodiment, the subject loses less
than 500 ml of fluid during hemodialysis. In another embodiment,
the subject loses less than 1 liter of fluid during hemodialysis.
In another embodiment, the subject loses between 0-1 liter of fluid
during hemodialysis. In another embodiment, the subject loses
between 0-1.5 liter of fluid during hemodialysis. In another
embodiment, the subject loses between 0-2 liter of fluid during
hemodialysis. In another embodiment, the subject completes the
hemodialysis without extra fluid weight. In another embodiment, the
subject has a total weight post-hemodialysis that is about the same
as the subject's weight pre-hemodialysis. In another embodiment,
the subject has a total weight post-hemodialysis that is within
1-20% of the subject's pre-hemodialysis total weight. In another
embodiment, the subject has a total weight post-hemodialysis that
is within 1-15% of the subject's pre-hemodialysis total weight. In
another embodiment, the subject has a total weight
post-hemodialysis that is within 1-10% of the subject's
pre-hemodialysis total weight. In another embodiment, the subject
has a total weight post-hemodialysis that is within 1-5% of the
subject's pre-hemodialysis total weight. In another embodiment, the
subject has a total weight post-hemodialysis that is within about
1, 2, 3, 4, 5, 6, 7, 8, 9 or 10% of the subject's pre-hemodialysis
total weight. In another embodiment, the subject has a
post-hemodialysis blood glucose level that is within 1-25% of the
subject's pre-hemodialysis blood glucose level. In another
embodiment, the subject has a post-hemodialysis blood glucose level
that is within 1-30% of the subject's pre-hemodialysis blood
glucose level. In another embodiment, the subject has a
post-hemodialysis blood glucose level that is within 1-15% of the
subject's pre-hemodialysis blood glucose level. In another
embodiment, the subject has a post-hemodialysis blood glucose level
that is within 1-10% of the subject's pre-hemodialysis blood
glucose level. In another embodiment, the subject has a
post-hemodialysis blood glucose level that is within 1-5% of the
subject's pre-hemodialysis blood glucose level. In another
embodiment, the subject has a post-hemodialysis blood glucose level
that is within 10% of their pre-hemodialysis blood glucose level.
In another embodiment, the subject has a post-hemodialysis blood
glucose level that is within 5% of the subject's pre-hemodialysis
blood glucose level. In another embodiment, the subject has a
post-hemodialysis blood glucose level that is within about 1, 2, 3,
4, 5, 6, 7, 8, 9 or 10% of the subject's pre-hemodialysis blood
glucose level. In another embodiment, the hemodialyis moduylates
the blood glucose levels of the subject. In another embodiment, the
subject's blood glucose levels vary less than 20%
during-hemodialysis. In another embodiment, the subject's blood
glucose levels vary less than 20% pre-, mid-, and
post-hemodialysis. In another embodiment, the subject's blood
glucose levels vary less than 10% during-hemodialysis In another
embodiment, the subject's blood glucose levels vary less than 10%
pre-, mid-, and post-hemodialysis. In another embodiment, the
subject's blood glucose levels vary less than 5%
during-hemodialysis. In another embodiment, the subject's blood
glucose levels vary less than 5% pre-, mid-, and post-hemodialysis.
In another embodiment, the subject's blood glucose levels vary less
than 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10% during-hemodialysis. In
another embodiment, the subject's blood glucose levels vary less
than 0-10% pre-, mid-, and post-hemodialysis. In another
embodiment, the subject's blood glucose levels decrease during
dialysis. In another embodiment, the subject's post-hemodialysis
blood glucose levels decrease by at least 20% as compared to the
subject's pre-hemodialysis glucose levels. In another embodiment,
the subject's post-hemodialysis blood glucose levels decrease by at
least 15% as compared to the subject's pre-hemodialysis glucose
levels. In another embodiment, the subject's post-hemodialysis
blood glucose levels decrease by at least 10% as compared to the
subject's pre-hemodialysis glucose levels. In another embodiment,
the subject's post-hemodialysis blood glucose levels decrease by at
least 5% as compared to the subject's pre-hemodialysis glucose
levels. In another embodiment, the subject's post-hemodialysis
blood glucose levels decrease by at least 1, 2, 3, 4, 5, 6, 7, 8,
9, or 10% as compared to the subject's pre-hemodialysis glucose
levels. In another embodiment, the subject's post-hemodialysis
blood glucose levels decrease by at least 2% as compared to the
subject's pre-hemodialysis glucose levels. In another embodiment,
the subject's post-hemodialysis blood glucose levels decrease by
0-10% as compared to the subject's pre-hemodialysis glucose levels.
In another embodiment, the subject's post-hemodialysis blood
glucose levels decrease by 0-5% as compared to the subject's
pre-hemodialysis glucose levels.
[0019] In another aspect, the invention provides for a method for
treating or preventing malnutrition in a hemodialysis subject in
need thereof, the method comprising formulating an aqueous
composition comprising between 1 and 10% mass/volume of dextrose, 7
to 20% mass/volume of amino acids of which at least 18% of said
amino acids are branched-chain amino acids, and less than 5%
mass/volume of lipids based on a body mass measurement of the
subject and parenterally administering said aqueous composition in
conjunction with the hemodialysis. In one embodiment the
composition is carbohydrate free. In another embodiment the
composition is lipid free. In another embodiment the formulating is
further based on the intended duration of the hemodialysis. In
another embodiment the duration of the hemodialysis is between 2 to
4.5 hrs. In another embodiment the duration of the hemodialysis is
between 2.75 to 4 hrs. In another embodiment the treating or
preventing said malnutrition comprises raising said subject's
albumin levels by 0.2-0.4 g/dL in 1 to 3 months. In another
embodiment the treating or preventing said malnutrition comprises
raising said subject's albumin levels to at least about 3.8 g/dL.
In another embodiment the subject's albumin levels increase by 0.1
g/deciliter within three months after the first administration of
said composition. In another embodiment the subject's albumin
levels increase by 0.2 g/deciliter within three months after the
first administration of said composition. In another embodiment the
composition is less than 430 mL in volume. In another embodiment
the subject has reduced side effects associated with infusion of an
aqueous composition during dialysis. In another embodiment the side
effects side effects are dyspnea, increased respiratory rate,
rhonchi, edema, hypertension, hernia, or anxiety. In another
embodiment the subject has reduced occurrence of hyperglycemia
during dialysis. In another embodiment the subject has a
post-hemodialysis blood glucose level that is within 1-20% of the
subject's pre-hemodialysis blood glucose level. In another
embodiment the subject has a post-hemodialysis blood glucose level
that is within 1-10% of the subject's pre-hemodialysis blood
glucose level. In another embodiment the subject has a
post-hemodialysis blood glucose level that is within 1-5% of the
subject's pre-hemodialysis blood glucose level. In another
embodiment the subject has reduced fluid accumulation during
dialysis. In another embodiment the subject loses between 0-5
liters of fluid during dialysis. In another embodiment the subject
loses between 0-4 liters of fluid during dialysis. In another
embodiment the subject loses between 0-3 liters of fluid during
dialysis. In another embodiment the subject loses between 0-2
liters of fluid during dialysis. In another embodiment the subject
loses between 0-1 liters of fluid during dialysis. In another
embodiment the subject has diabetes. In another embodiment the
aqueous composition does not comprise lipids. In another embodiment
the amino acids comprise at least 18% branched chain amino acids.
In another embodiment the amino acids comprise more than 20%
branched amino acids. In another embodiment the amino acids
comprise more than 30% branched amino acids. In another embodiment
the amino acids comprise more than 40% branched amino acids. In
another embodiment the amino acids comprise more than 50% branched
amino acids. In another embodiment the subject leaves the
hemodialysis without gaining any fluid weight. In another
embodiment the treating or preventing malnutrition comprises
modulating blood glucose levels of a subject. In another embodiment
the blood glucose levels of said subject vary less than 10% from
pre-hemodialysis to post-hemodialysis. In another embodiment the
blood glucose levels of said subject decrease by at least 2% from
pre-hemodialysis to post-hemodialysis.
[0020] In another aspect, the invention provides for a method for
treating or preventing malnutrition in a hemodialysis subject in
need thereof, the method comprising formulating an aqueous
composition comprising less than 0.1 g/mL of dextrose, and 7 to 20%
mass/volume of amino acids based on a body mass measurement of the
subject and parenterally administering said aqueous composition in
conjunction with the hemodialysis. In one embodiment the
composition is carbohydrate free. In another embodiment the
composition is lipid free. In another embodiment the formulating is
further based on the intended duration of the hemodialysis. In
another embodiment the duration of the hemodialysis is between 2 to
4.5 hrs. In another embodiment the duration of the hemodialysis is
between 2.75 to 4 hrs. In another embodiment the treating or
preventing said malnutrition comprises raising said subject's
albumin levels by 0.2-0.4 g/dL in 1 to 3 months. In another
embodiment the treating or preventing said malnutrition comprises
raising said subject's albumin levels to at least about 3.8 g/dL.
In another embodiment the subject's albumin levels increase by 0.1
g/deciliter within three months after the first administration of
said composition. In another embodiment the subject's albumin
levels increase by 0.2 g/deciliter within three months after the
first administration of said composition. In another embodiment the
composition is less than 430 mL in volume. In another embodiment
the subject has reduced side effects associated with infusion of an
aqueous composition during dialysis. In another embodiment the side
effects side effects are dyspnea, increased respiratory rate,
rhonchi, edema, hypertension, hernia, or anxiety. In another
embodiment the subject has reduced occurrence of hyperglycemia
during dialysis. In another embodiment the subject has a
post-hemodialysis blood glucose level that is within 1-20% of the
subject's pre-hemodialysis blood glucose level. In another
embodiment the subject has a post-hemodialysis blood glucose level
that is within 1-10% of the subject's pre-hemodialysis blood
glucose level. In another embodiment the subject has a
post-hemodialysis blood glucose level that is within 1-5% of the
subject's pre-hemodialysis blood glucose level. In another
embodiment the subject has reduced fluid accumulation during
dialysis. In another embodiment the subject loses between 0-5
liters of fluid during dialysis. In another embodiment the subject
loses between 0-4 liters of fluid during dialysis. In another
embodiment the subject loses between 0-3 liters of fluid during
dialysis. In another embodiment the subject loses between 0-2
liters of fluid during dialysis. In another embodiment the subject
loses between 0-1 liters of fluid during dialysis. In another
embodiment the subject has diabetes. In another embodiment the
aqueous composition does not comprise lipids. In another embodiment
the amino acids comprise at least 18% branched chain amino acids.
In another embodiment the amino acids comprise more than 20%
branched amino acids. In another embodiment the amino acids
comprise more than 30% branched amino acids. In another embodiment
the amino acids comprise more than 40% branched amino acids. In
another embodiment the amino acids comprise more than 50% branched
amino acids. In another embodiment the subject leaves the
hemodialysis without gaining any fluid weight. In another
embodiment the treating or preventing malnutrition comprises
modulating blood glucose levels of a subject. In another embodiment
the blood glucose levels of said subject vary less than 10% from
pre-hemodialysis to post-hemodialysis. In another embodiment the
blood glucose levels of said subject decrease by at least 2% from
pre-hemodialysis to post-hemodialysis.
[0021] In another aspect, the invention provides for a method
method for treating or preventing malnutrition in a hemodialysis
subject in need thereof, the method comprising formulating a
lipid-free aqueous composition comprising less than 0.1 g/mL of
dextrose, and 7 to 20% mass/volume of amino acids based on a body
mass measurement of the subject and parenterally administering said
aqueous composition in conjunction with the hemodialysis.
[0022] In another aspect, the invention provides for a method
method for treating or preventing malnutrition in a hemodialysis
subject in need thereof, the method comprising formulating an
aqueous composition that is free of lipid, dextrose, fructose,
sucrose, lactose, galactose, mannose, maltose, ribose, arabinose,
sorbose, glyceraldehyde, or glycerol, comprising 7 to 20%
mass/volume of amino acids based on a body mass measurement of the
subject and parenterally administering said aqueous composition in
conjunction with the hemodialysis. In one embodiment the
composition is carbohydrate free. In another embodiment the
composition is lipid free. In another embodiment the formulating is
further based on the intended duration of the hemodialysis. In
another embodiment the duration of the hemodialysis is between 2 to
4.5 hrs. In another embodiment the duration of the hemodialysis is
between 2.75 to 4 hrs. In another embodiment the treating or
preventing said malnutrition comprises raising said subject's
albumin levels by 0.2-0.4 g/dL in 1 to 3 months. In another
embodiment the treating or preventing said malnutrition comprises
raising said subject's albumin levels to at least about 3.8 g/dL.
In another embodiment the subject's albumin levels increase by 0.1
g/deciliter within three months after the first administration of
said composition. In another embodiment the subject's albumin
levels increase by 0.2 g/deciliter within three months after the
first administration of said composition. In another embodiment the
composition is less than 430 mL in volume. In another embodiment
the subject has reduced side effects associated with infusion of an
aqueous composition during dialysis. In another embodiment the side
effects side effects are dyspnea, increased respiratory rate,
rhonchi, edema, hypertension, hernia, or anxiety. In another
embodiment the subject has reduced occurrence of hyperglycemia
during dialysis. In another embodiment the subject has a
post-hemodialysis blood glucose level that is within 1-20% of the
subject's pre-hemodialysis blood glucose level. In another
embodiment the subject has a post-hemodialysis blood glucose level
that is within 1-10% of the subject's pre-hemodialysis blood
glucose level. In another embodiment the subject has a
post-hemodialysis blood glucose level that is within 1-5% of the
subject's pre-hemodialysis blood glucose level. In another
embodiment the subject has reduced fluid accumulation during
dialysis. In another embodiment the subject loses between 0-5
liters of fluid during dialysis. In another embodiment the subject
loses between 0-4 liters of fluid during dialysis. In another
embodiment the subject loses between 0-3 liters of fluid during
dialysis. In another embodiment the subject loses between 0-2
liters of fluid during dialysis. In another embodiment the subject
loses between 0-1 liters of fluid during dialysis. In another
embodiment the subject has diabetes. In another embodiment the
aqueous composition does not comprise lipids. In another embodiment
the amino acids comprise at least 18% branched chain amino acids.
In another embodiment the amino acids comprise more than 20%
branched amino acids. In another embodiment the amino acids
comprise more than 30% branched amino acids. In another embodiment
the amino acids comprise more than 40% branched amino acids. In
another embodiment the amino acids comprise more than 50% branched
amino acids. In another embodiment the subject leaves the
hemodialysis without gaining any fluid weight. In another
embodiment the treating or preventing malnutrition comprises
modulating blood glucose levels of a subject. In another embodiment
the blood glucose levels of said subject vary less than 10% from
pre-hemodialysis to post-hemodialysis. In another embodiment the
blood glucose levels of said subject decrease by at least 2% from
pre-hemodialysis to post-hemodialysis.
[0023] In another aspect, the invention provides for a method for
treating or preventing malnutrition in a hemodialysis subject in
need thereof, the method comprising formulating a carbohydrate free
and lipid-free aqueous composition comprising 7 to 20% mass/volume
of amino acids based on a body mass measurement of the subject and
parenterally administering said aqueous composition in conjunction
with the hemodialysis. In one embodiment the composition is
carbohydrate free. In another embodiment the composition is lipid
free. In another embodiment the formulating is further based on the
intended duration of the hemodialysis. In another embodiment the
duration of the hemodialysis is between 2 to 4.5 hrs. In another
embodiment the duration of the hemodialysis is between 2.75 to 4
hrs. In another embodiment the treating or preventing said
malnutrition comprises raising said subject's albumin levels by
0.2-0.4 g/dL in 1 to 3 months. In another embodiment the treating
or preventing said malnutrition comprises raising said subject's
albumin levels to at least about 3.8 g/dL. In another embodiment
the subject's albumin levels increase by 0.1 g/deciliter within
three months after the first administration of said composition. In
another embodiment the subject's albumin levels increase by 0.2
g/deciliter within three months after the first administration of
said composition. In another embodiment the composition is less
than 430 mL in volume. In another embodiment the subject has
reduced side effects associated with infusion of an aqueous
composition during dialysis. In another embodiment the side effects
side effects are dyspnea, increased respiratory rate, rhonchi,
edema, hypertension, hernia, or anxiety. In another embodiment the
subject has reduced occurrence of hyperglycemia during dialysis. In
another embodiment the subject has a post-hemodialysis blood
glucose level that is within 1-20% of the subject's
pre-hemodialysis blood glucose level. In another embodiment the
subject has a post-hemodialysis blood glucose level that is within
1-10% of the subject's pre-hemodialysis blood glucose level. In
another embodiment the subject has a post-hemodialysis blood
glucose level that is within 1-5% of the subject's pre-hemodialysis
blood glucose level. In another embodiment the subject has reduced
fluid accumulation during dialysis. In another embodiment the
subject loses between 0-5 liters of fluid during dialysis. In
another embodiment the subject loses between 0-4 liters of fluid
during dialysis. In another embodiment the subject loses between
0-3 liters of fluid during dialysis. In another embodiment the
subject loses between 0-2 liters of fluid during dialysis. In
another embodiment the subject loses between 0-1 liters of fluid
during dialysis. In another embodiment the subject has diabetes. In
another embodiment the aqueous composition does not comprise
lipids. In another embodiment the amino acids comprise at least 18%
branched chain amino acids. In another embodiment the amino acids
comprise more than 20% branched amino acids. In another embodiment
the amino acids comprise more than 30% branched amino acids. In
another embodiment the amino acids comprise more than 40% branched
amino acids. In another embodiment the amino acids comprise more
than 50% branched amino acids. In another embodiment the subject
leaves the hemodialysis without gaining any fluid weight. In
another embodiment the treating or preventing malnutrition
comprises modulating blood glucose levels of a subject. In another
embodiment the blood glucose levels of said subject vary less than
10% from pre-hemodialysis to post-hemodialysis. In another
embodiment the blood glucose levels of said subject decrease by at
least 2% from pre-hemodialysis to post-hemodialysis.
[0024] In another aspect, the invention provides for a sterile
aqueous composition for parenteral administration comprising:
between 2 and 26 g of dextrose; and between 12 and 45 g of amino
acids, comprising more than 18% branched amino acids; wherein the
composition is dosage form having a volume less than 450 mL. In one
embodiment the amino acids comprise more than 20% branched amino
acids. In another embodiment the amino acids comprise more than 30%
branched amino acids. In another embodiment the amino acids
comprise more than 40% branched amino acids. In another embodiment
the amino acids comprise more than 50% branched amino acids. In
another embodiment the composition further comprises lipids. In
another embodiment the composition is lipid free. In another
embodiment the lipids are present in the aqueous composition in an
amount between 5 to 30% mass/volume. In another embodiment the
lipids are present in the aqueous composition in an amount less
than 5% mass/volume. In another embodiment the composition further
comprises micronutrients. In another embodiment the composition is
contained within a sterile container suitable for parenteral
administration of the aqueous composition.
[0025] In another aspect, the invention provides for a sterile
aqueous composition for parenteral administration comprising: less
than 0.1 g/mL of dextrose; and between 12 and 45 g of amino acids,
wherein the composition is a lipid-free dosage form having a volume
less than 450 mL. In one embodiment the amino acids comprise
seventeen amino acids. In another embodiment the seventeen amino
acids are lysine, leucine, phenylalanine, valine, histidine,
isoleucine, methionine, threonine, tryptophan, alanine, arginine,
glycine, proline, glutamic acid, serine, aspartic acid, and
tyrosine. In another embodiment the amino acids comprise at least
18% branched chain amino acids. In another embodiment the amino
acids comprise more than 20% branched amino acids. In another
embodiment the amino acids comprise more than 30% branched amino
acids. In another embodiment the amino acids comprise more than 40%
branched amino acids. In another embodiment the amino acids
comprise more than 50% branched amino acids. In another embodiment
the composition further comprises micronutrients. In another
embodiment the composition is contained within a sterile container
suitable for parenteral administration of the aqueous composition.
In another embodiment the composition is lipid free. In another
embodiment the composition is carbohydrate free.
[0026] In another aspect, the invention provides for a sterile
aqueous composition for parenteral administration comprising:
between 12 and 45 g of amino acids, wherein the composition is a
lipid and carbohydrate-free dosage form having a volume less than
450 mL. In one embodiment the amino acids comprise seventeen amino
acids. In another embodiment the seventeen amino acids are lysine,
leucine, phenylalanine, valine, histidine, isoleucine, methionine,
threonine, tryptophan, alanine, arginine, glycine, proline,
glutamic acid, serine, aspartic acid, and tyrosine. In another
embodiment the amino acids comprise at least 18% branched chain
amino acids. In another embodiment the amino acids comprise more
than 20% branched amino acids. In another embodiment the amino
acids comprise more than 30% branched amino acids. In another
embodiment the amino acids comprise more than 40% branched amino
acids. In another embodiment the amino acids comprise more than 50%
branched amino acids. In another embodiment the composition further
comprises micronutrients. In another embodiment the composition is
contained within a sterile container suitable for parenteral
administration of the aqueous composition. In another embodiment
the composition is lipid free. In another embodiment the
composition is carbohydrate free.
BRIEF DESCRIPTION OF THE FIGURES
[0027] FIG. 1 describes IDPN compositions administrable over an
infusion time of 3.25-3.5 hours. The formulation of the IDPN
compositions vary by the body mass of the subject to which the IDPN
composition is administered.
[0028] FIG. 2 describes the rates at which an IDPN composition of
FIG. 1 is administered during the first and second weeks of
therapy.
[0029] FIG. 3 describes IDPN compositions administrable over an
infusion time of 3.25-3.5 hours. The formulation of the IDPN
compositions vary by the body mass of the subject to which the IDPN
composition is administered.
[0030] FIG. 4 describes the rates at which an IDPN composition of
FIG. 3 is administered during the first and second weeks of
therapy.
[0031] FIG. 5 describes IDPN compositions administrable over an
infusion time of 2.75-3.0 hours. The formulation of the IDPN
compositions vary by the body mass of the subject to which the IDPN
composition is administered.
[0032] FIG. 6 describes the rates at which an IDPN composition of
FIG. 5 is administered during the first and second weeks of
therapy.
[0033] FIG. 7 describes IDPN compositions administrable over an
infusion time of 3.25-3.5 hours. The formulation of the IDPN
compositions vary by the body mass of the subject to which the IDPN
composition is administered.
[0034] FIG. 8 describes the rates at which an IDPN composition of
FIG. 7 is administered during the first and second weeks of
therapy.
[0035] FIG. 9 describes IDPN compositions administrable over an
infusion time of 3.75-4.0 hours. The formulation of the IDPN
compositions vary by the body mass of the subject to which the IDPN
composition is administered.
[0036] FIG. 10 describes the rates at which an IDPN composition of
FIG. 9 is administered during the first and second weeks of
therapy.
[0037] FIG. 11 describes IDPN compositions administrable over an
infusion time of 2.75-3.0 hours. The formulation of the IDPN
compositions vary by the body mass of the subject to which the IDPN
composition is administered.
[0038] FIG. 12 describes the rates at which an IDPN composition of
FIG. 11 is administered during the first and second weeks of
therapy.
[0039] FIG. 13 describes IDPN compositions administrable over an
infusion time of 3.25-3.5 hours. The formulation of the IDPN
compositions vary by the body mass of the subject to which the IDPN
composition is administered.
[0040] FIG. 14 describes the rates at which an IDPN composition of
FIG. 13 is administered during the first and second weeks of
therapy.
[0041] FIG. 15 describes IDPN compositions administrable over an
infusion time of 3.75-4.0 hours. The formulation of the IDPN
compositions vary by the body mass of the subject to which the IDPN
composition is administered.
[0042] FIG. 16 describes the rates at which an IDPN composition of
FIG. 15 is administered during the first and second weeks of
therapy.
[0043] FIG. 17 describes IDPN compositions administrable over a
diffusion time of 2.75-3.0 hours. The formulation of the IDPN
compositions vary by the body mass of the subject to which the IDPN
composition is administered.
[0044] FIG. 18 describes the rates at which an IDPN composition of
FIG. 17 is administered during the first and second weeks of
therapy.
[0045] FIG. 19 describes IDPN compositions administrable over a
diffusion time of 3.75-4.0 hours. The formulation of the IDPN
compositions vary by the body mass of the subject to which the IDPN
composition is administered.
[0046] FIG. 20 describes the rates at which an IDPN composition of
FIG. 19 is administered during the first and second weeks of
therapy.
[0047] FIG. 21 describes IDPN compositions administrable over a
diffusion time of 2.75-3.0 hours. The formulation of the IDPN
compositions vary by the body mass of the subject to which the IDPN
composition is administered.
[0048] FIG. 22 describes the rates at which an IDPN composition of
FIG. 21 is administered during the first and second weeks of
therapy.
[0049] FIG. 23 describes IDPN compositions administrable over a
diffusion time of 3.75-4.0 hours. The formulation of the IDPN
compositions vary by the body mass of the subject to which the IDPN
composition is administered.
[0050] FIG. 24 describes the rates at which an IDPN composition of
FIG. 23 is administered during the first and second weeks of
therapy.
[0051] FIG. 25 describes lipid-containing IDPN compositions
administrable over a diffusion time of 2.75-3.0 hours. The
formulation of the IDPN compositions vary by the body mass of the
subject to which the IDPN composition is administered.
[0052] FIG. 26 describes the rates at which an IDPN composition of
FIG. 25 is administered during the first, second, and third weeks
of therapy.
[0053] FIG. 27 describes lipid-containing IDPN compositions
administrable over a diffusion time of 3.75-4.0 hours. The
formulation of the IDPN compositions vary by the body mass of the
subject to which the IDPN composition is administered.
[0054] FIG. 28 describes the rates at which an IDPN composition of
FIG. 27 is administered during the first, second, and third weeks
of therapy.
[0055] FIG. 29 describes lipid-containing IDPN compositions
administrable over a diffusion time of 3.25-3.5 hours. The
formulation of the IDPN compositions vary by the body mass of the
subject to which the IDPN composition is administered.
[0056] FIG. 30 describes the rates at which an IDPN composition of
FIG. 29 is administered during the first, second, and third weeks
of therapy.
[0057] FIG. 31 describes lipid-containing IDPN compositions
administrable over a diffusion time of 2.75-3.0 hours. The
formulation of the IDPN compositions vary by the body mass of the
subject to which the IDPN composition is administered.
[0058] FIG. 32 describes the rates at which an IDPN composition of
FIG. 31 is administered during the first, second, and third weeks
of therapy.
[0059] FIG. 33 describes lipid-containing IDPN compositions
administrable over a diffusion time of 3.75-4.0 hours. The
formulation of the IDPN compositions vary by the body mass of the
subject to which the IDPN composition is administered.
[0060] FIG. 34 describes the rates at which an IDPN composition of
FIG. 33 is administered during the first, second, and third weeks
of therapy.
[0061] FIG. 35 describes lipid-containing IDPN compositions
administrable over a diffusion time of 3.25-3.5 hours. The
formulation of the IDPN compositions vary by the body mass of the
subject to which the IDPN composition is administered.
[0062] FIG. 36 describes the rates at which an IDPN composition of
FIG. 35 is administered during the first, second, and third weeks
of therapy.
[0063] FIG. 37 illustrates the serum albumin levels in diabetic
subjects of a study described in Example 22. A) describes Group I
subjects' baseline mean levels. B) describes Group I subjects' 3
month mean levels. C) describes Group II subjects' baseline mean
levels. D) describes Group II subjects' 3 month mean levels. The
y-axis describes serum albumin levels in g/L.
[0064] FIG. 38 illustrates the albumin levels in non-diabetic
subjects of a study described in Example 23. A) describes Group I
subjects' baseline mean levels. B) describes Group I subjects' 3
month mean levels. C) describes Group II subjects' baseline mean
levels. D) describes Group II subjects' 3 month mean levels. The
y-axis describes serum albumin levels in g/L.
[0065] FIG. 39 illustrates the albumin levels in all subjects of a
study described in Example 29. A) describes the low-volume
subjects' baseline mean levels. B) describes the low-volume
subjects' 3 month mean levels. C) describes the high-volume
subjects' baseline mean levels. D) describes the high-volume
subjects' 3 month mean levels. The y-axis describes serum albumin
levels in g/L.
[0066] FIG. 40 illustrates the albumin levels in the diabetic
subjects of a study described in Example 29. A) describes the
low-volume diabetic subjects' baseline mean levels. B) describes
the low-volume diabetic subjects' 3 month mean levels. C) describes
the high-volume diabetic subjects' baseline mean levels. D)
describes the high-volume diabetic subjects' 3 month mean levels.
The y-axis describes serum albumin levels in g/L.
[0067] FIG. 41 illustrates a chart of the response of subjects
receiving the low-volume IDPN composition in Example 29.
[0068] FIG. 42 illustrates a chart of the response of subjects
receiving the high-volume IDPN composition in Example 29.
[0069] FIG. 43 illustrates a chart of the response of diabetic
subjects to the low-volume IDPN composition in Example 29.
[0070] FIG. 44 illustrates a chart of the response of non-diabetic
subjects to the low-volume IDPN composition in Example 29.
DETAILED DESCRIPTION
[0071] As used herein, the term "amino acid" refers to any of the
twenty genetically-encoded L-a-amino acids unless indicated
otherwise.
[0072] As used herein, the term "infusion time" refers to the
amount of time during which a composition is administered to a
subject via dialysis.
[0073] As used herein, the term "about" means.+-.10%.
[0074] A need exists for an improved IDPN composition for
administration to subjects that diminishes hyperglycemia associated
with IDPN administration and decreases the need for the
administration of insulin with IDPN. Moreover, a need exists for a
lower volume IDPN dosage form.
[0075] In one embodiment, intradialytic parenteral nutrition (IDPN)
compositions with low glucose levels and low composition volume are
provided. In some embodiments, the IDPN compositions allow medical
personnel to engage in reduced carbohydrate management for MHD
subjects when the subjects receive IDPN. In another embodiment, an
IDPN composition is effective for treating or preventing
malnutrition in a MHD subject with glucose management difficulties,
insulin resistance, type I diabetes, type II diabetes, and/or
pancreatitis. In another embodiment, administration of an IDPN
composition promotes anabolism over catabolism, thereby treating or
preventing malnutrition. In some embodiments, an IDPN composition
has reduced volume, and in some embodiments, the reduced volume can
reduce side effects associated with high infusion volumes.
Non-limiting examples of the side effects associated with high
infusion volumes include dyspnea, increased respiratory rate,
rhonchi, edema, hypertension, hernia, and anxiety. In some
embodiments, a subject receiving an IDPN composition experiences
reduced symptoms of hyperglycemia.
[0076] When performing dialysis, the volume of a fluid infused into
a subject can have affects on the subject. For example, different
dialysis fluids, differing in volume only, can have differing
affects on a subject owing to the differing volumes. Higher volumes
can cause complications in subjects, such as increased fluid
retention, decreased nutrient absorption, discomfort, longer or
additional dialysis treatment times, and operational
inconvenience.
[0077] One goal of fluid removal during hemodialysis is to return
the subject to dry weight by the end of the dialysis session. Dry
weight is the lowest post dialysis weight that the subject can
tolerate without developing symptoms of hypotension. Dry weight is
generally a clinical estimate and the subject may still be
over-hydrated. Some subjects do not tolerate fluid removal well,
and excess fluid removal results symptoms such as cramps or a fall
in blood pressure. For other subjects not removing enough fluid
leaves the subject overloaded with fluid, puts strain on the heart,
causes high blood pressure high, or leads to difficulties for the
next treatment of hemodialysis. In some instances, excess fluid
accumulations in dialysis subjects leads to congestive heart
failure and hospital admissions. In one embodiment, a dry weight is
targeted where the patient will be normally hydrated and fluid
removal is at a rate, which keeps the patient comfortable. In some
embodiments, the administration of low-volume IDPN compositions
results in the achievement of desired fluid removal goals as
determined by the dialysis clinician. In some embodiments, after
administration of low-volume IDPN compositions, the patient does
not leave the dialysis treatment with extra fluid weight.
[0078] In some embodiments, administration of low-volume IDPN
compositions results in the achievement of desired fluid removal
goals for a subject as determined by the dialysis clinician. In
other embodiments, low-volume IDPN compositions are administered to
a subject, whereby the hemodialysis subject does not have extra
fluid weight after dialysis treatment. In another embodiment,
low-volume IDPN compositions are administered to a hemodialysis
subject, whereby the subject has less extra fluid weight after
dialysis treatment as compared to administration with higher-volume
IDPN compositions. In another embodiment, the subject has reduced
fluid accumulation during hemodialysis. In another embodiment, the
subject accumulates less than 3 liter of fluid during hemodialysis.
In another embodiment, the subject accumulates less than 2 liter of
fluid during hemodialysis. In another embodiment, the subject
accumulates less than 1 liter of fluid during hemodialysis. In
another embodiment, the subject accumulates less than 500 ml of
fluid during hemodialysis. In another embodiment, the subject
accumulates about 0-3 liter of fluid during hemodialysis. In
another embodiment, the subject has a lower fluid weight
post-hemodialysis then pre-hemodialysis. In another embodiment, the
subject loses less than 100 ml of fluid during hemodialysis. In
another embodiment, the subject loses less than 250 ml of fluid
during hemodialysis. In another embodiment, the subject loses less
than 500 ml of fluid during hemodialysis. In another embodiment,
the subject loses less than 1 liter of fluid during hemodialysis.
In another embodiment, the subject loses between 0-1 liter of fluid
during hemodialysis. In another embodiment, the subject loses
between 0-1.5 liter of fluid during hemodialysis. In another
embodiment, the subject loses between 0-2 liter of fluid during
hemodialysis.
[0079] In one embodiment a subject is administered a dialysis
composition with a reduced volume to provide nutrition to the
subject with reduced liquid infusion. In one embodiment, the
subject has reduced side effects after infusion of the composition
with a reduced volume. In one embodiment, a subject has reduced
fluid accumulation after infusion, during hemodialysis, of an IDPN
composition with a reduced volume. In one embodiment, the IDPN
composition has a low percentage of carbohydrates. In another
embodiment, the IDPN composition has a low amount of carbohydrates.
In one embodiment, the IDPN composition has a low percentage of an
energy source that is not a carbohydrate. In another embodiment,
the IDPN composition has a low amount of an energy source that is
not a carbohydrate. In another embodiment, the IDPN composition
lacks lipids. In another embodiment, the IDPN composition further
comprises lipids. In one embodiment, the IDPN composition comprises
less than 5% lipids mass/volume.
[0080] In one embodiment, the IDPN composition has a volume less
than about 750 mL, less than about 700 mL, less than about 650 mL,
less than about 600 mL, less than about 590 mL, less than about 580
mL, less than about 570 mL, less than about 560 mL, less than about
550 mL, less than about 540 mL, less than about 530 mL, less than
about 520 mL, less than about 510 mL, less than about 500 mL, less
than about 490 mL, less than about 480 mL, less than about 470 mL,
less than about 460 mL, less than about 450 mL, less than about 440
mL, less than about 430 mL, less than about 420 mL, less than about
410 mL, less than about 400 mL, less than about 390 mL, less than
about 380 mL, less than about 370 mL, less than about 360 mL, less
than about 350 mL, less than about 340 mL, less than about 330 mL,
less than about 320 mL, less than about 310 mL, less than about 300
mL, less than about 250 mL, or less than about 200 mL.
[0081] In one embodiment, IDPN compositions are provided for
subjects at various stages of life. In another embodiment IDPN
compositions are adapted to meet the nutritional needs of subjects
across a broad range of ages. In another embodiment, a subject is
an adult. In another embodiment, a subject is a young adult. In
another embodiment, a subject is a juvenile. In another embodiment,
a subject is an adolescent. In another embodiment, a subject is a
child. In another embodiment, a subject is eligible to receive
pediatric health care. In another embodiment, a subject is a
pediatric subject. In another embodiment, a subject is over about
18 years old. In another embodiment, a subject is under about 18
years old. In another embodiment, a subject is under about 12 years
old. In another embodiment, a subject is under about 8 years old.
In another embodiment, a subject is from about 1 to about 18 years
old. In another embodiment, a subject is from about 5 to about 12
years old. In another embodiment, a subject is about 1, about 2,
about 3, about 4, about 5, about 6, about 7, about 8, about 9,
about 10, about 11, about 12, about 13, about 14, about 15, about
16, about 17, or about 18 years old. In another embodiment, a
subject is a neonatal subject. In another embodiment, a subject is
less than about a year old. In another embodiment, a s subject is
about 1, about 2, about 3, about 4, about 5, about 6, about 7,
about 8, about 9, about 10, about 11, or about 12 months old. In
another embodiment, the subject is diabetic. In another embodiment,
the subject is non-diabetic. In another embodiment, the subject is
either diabetic or non-diabetic. In another embodiment, the subject
has high blood sugar. In another embodiment, the subject has low
levels of insulin. In another embodiment, the subject has low
levels of insulin because the pancreas makes too little insulin, or
is insulin resistant.
[0082] In one embodiment, an IDPN composition comprises a
carbohydrate and an amino acid. In one embodiment, an IDPN
composition consists essentially of amino acids and dextrose in an
aqueous solution. In another embodiment, an IDPN composition
further comprises lipids. In another embodiment, an IDPN
composition comprises micronutrients, such as a vitamin, a trace
element and/or a mineral. In another embodiment, an IDPN
composition comprises one or more pharmaceutical agents, such as
insulin. In another embodiment, one or more pharmaceutical agents
are co-administered with an IDPN composition. For example, insulin
can be co-administered by any ordinary method of administration,
for example, subcutaneous injection. In another embodiment, an IDPN
composition comprises a carbohydrate, an amino acid, and a lipid.
In another embodiment, an IDPN composition comprises a
carbohydrate, an amino acid, and a micronutrient, such as a
vitamin, a trace element, and/or a mineral. In another embodiment,
an IDPN composition comprises a carbohydrate, an amino acid, a
lipid, and a micronutrient, such as a vitamin, a trace element,
and/or a mineral. In another embodiment, an IDPN composition
comprises a carbohydrate, an amino acid, and one or more
pharmaceutical agents. In another embodiment, an IDPN composition
comprises a carbohydrate, an amino acid, a lipid, and one or more
pharmaceutical agents. In another embodiment, an IDPN composition
comprises a carbohydrate, an amino acid, a micronutrient, and one
or more pharmaceutical agents. In another embodiment, an IDPN
composition comprises a carbohydrate, an amino acid, a lipid, a
micronutrient, and one or more pharmaceutical agents.
[0083] In one embodiment, an IDPN composition is a solution. In
another embodiment, an IDPN composition is homogeneous. In another
embodiment, an IDPN composition is the product of contacting a
powder with sterile water. In another embodiment, IDPN composition
is the product of contacting a powder with saline. In another
embodiment, an IDPN composition is a suspension.
[0084] In one embodiment, a carbohydrate comprises one or more of
dextrose (D-glucose), fructose, sucrose, lactose, galactose,
mannose, maltose, ribose, arabinose, sorbose, and glyceraldehyde.
In another embodiment, the carbohydrate comprises dextrose. In
another embodiment, the carbohydrate is dextrose. In one
embodiment, the energy source that is not a carbohydrate is
glycerol.
[0085] In one embodiment, an IDPN composition comprises an amino
acid. In another embodiment, an IDPN composition comprises two or
more amino acids. In another embodiment, an IDPN composition
comprises 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16,
17, 18, 19, or 20 amino acids. In another embodiment, an IDPN
composition comprises twenty amino acids. In another embodiment, an
IDPN composition comprises 17 amino acids. In another embodiment,
an IDPN composition comprises amino acids that consist essentially
of lysine, leucine, phenylalanine, valine, histidine, isoleucine,
methionine, threonine, tryptophan, alanine, arginine, glycine,
proline, glutamic acid, serine, aspartic acid, and tyrosine. In
another embodiment an IDPN composition comprises one or more amino
acids that are not genetically-encoded. In another embodiment, an
IDPN composition comprises one or more of alanine, arginine,
asparagine, aspartic acid, cysteine, glutamic acid, glutamine,
glycine, histidine, imidazole, isoleucine, leucine, lysine,
methionine, phenylalanine, serine, threonine, tryptophan, tyrosine,
or valine. In another embodiment, an IDPN composition comprises
lysine, leucine, phenylalanine, valine, histidine, isoleucine,
methionine, threonine, tryptophan, alanine, arginine, glycine,
proline, glutamic acid, serine, aspartic acid, and tyrosine. In
another embodiment, an IDPN composition comprises amino acids that
consist of lysine, leucine, phenylalanine, valine, histidine,
isoleucine, methionine, threonine, tryptophan, alanine, arginine,
glycine, proline, glutamic acid, serine, aspartic acid, and
tyrosine. In another embodiment, an IDPN composition comprises
essential amino acids. In another embodiment, an IDPN composition
comprises non-essential amino acids. In another embodiment, an IDPN
composition comprises essential and non-essential amino acids. In
another embodiment, an IDPN composition comprises amino acids that
consist essentially of essential amino acids. In another
embodiment, an IDPN composition comprises isoleucine, argenine,
lysine, methionine, phenylalanine, threonine, tryptophan, valine,
histidine, tyrosine, leucine. In another embodiment, an IDPN
composition comprises amino acids that consist essentially of
isoleucine, argenine, lysine, methionine, phenylalanine, threonine,
tryptophan, valine, histidine, tyrosine, leucine. In another
embodiment, an IDPN composition comprises leucine, isoleucine,
valine, lysine, phenylalanine, histidine, threonine, methionine,
tryptophan, alanine, argenine, glycine, proline, serine, and
tyrosine. In another embodiment, an IDPN composition comprises
amino acids that consist essentially of leucine, isoleucine,
valine, lysine, phenylalanine, histidine, threonine, methionine,
tryptophan, alanine, argenine, glycine, proline, serine, and
tyrosine. In another embodiment, an IDPN composition comprises
leucine, isoleucine, valine, lysine, phenylalanine, histidine,
threonine, methionine, tryptophan, alanine, argenine, glycine,
proline, serine, and cysteine. In another embodiment, an IDPN
composition comprises amino acids that consist essentially of
leucine, isoleucine, valine, lysine, phenylalanine, histidine,
threonine, methionine, tryptophan, alanine, argenine, glycine,
proline, serine, and cysteine. In another embodiment, an IDPN
composition comprises branched amino acids. In another embodiment,
an IDPN composition comprises amino acids that consist essentially
of branched amino acids. In another embodiment, an IDPN composition
comprises leucine, isoleucine, and valine. In another embodiment,
an IDPN composition comprises amino acids that consist essentially
of leucine, isoleucine, and valine. In another embodiment an IDPN
composition comprises one or more amino acids that are not
genetically-encoded. In another embodiment, an IDPN composition
comprises one or more amino acids that are unnatural. In another
embodiment, an IDPN composition comprises one or more amino acids
that are synthetic. In another embodiment, an IDPN composition
comprises one or more amino acids that are artificial. In another
embodiment, an IDPN composition comprises one or more amino acids
that are encoded by a nucleic acid molecule that is natural or
unnatural. In another embodiment, an IDPN composition comprises one
or more peptides. In another embodiment, an IDPN composition
comprises amino acids and peptides. In another embodiment, an IDPN
composition comprises one or more proteins. In another embodiment,
an IDPN composition comprises amino acids, peptides, and proteins.
In another embodiment, a peptide comprises 2, 3, 4, 5, 6, 7, 8, 9,
or 10 amino acid residues. In another embodiment, a peptide
comprises at least 10 amino acid residues. In another embodiment,
an IDPN composition comprises 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11,
12, 13, 14, 15, 16, 17, 18, 19, or 20 of alanine, arginine,
asparagine, aspartic acid, cysteine, glutamic acid, glutamine,
glycine, histidine, imidazole, isoleucine, leucine, lysine,
methionine, phenylalanine, serine, threonine, tryptophan, tyrosine,
and valine.
[0086] In one embodiment, the percentage of lysine is less than 10%
of the total amount of amino acids contained in the IDPN
composition. In another embodiment, the percentage of lysine is
less than 11% of the total amount of amino acids contained in the
IDPN composition. In another embodiment, the percentage of lysine
is less than 12% of the total amount of amino acids contained in
the IDPN composition. In another embodiment, the percentage of
lysine is less than 13% of the total amount of amino acids
contained in the IDPN composition. In another embodiment, the
percentage of lysine is less than 14% of the total amount of amino
acids contained in the IDPN composition. In another embodiment, the
percentage of lysine is less than 15% of the total amount of amino
acids contained in the IDPN composition. In another embodiment, the
percentage of leucine is less than 10% of the total amount of amino
acids contained in the IDPN composition. In another embodiment, the
percentage of leucine is less than 11% of the total amount of amino
acids contained in the IDPN composition. In another embodiment, the
percentage of leucine is less than 12% of the total amount of amino
acids contained in the IDPN composition. In another embodiment, the
percentage of leucine is less than 9% of the total amount of amino
acids contained in the IDPN composition. In another embodiment, the
percentage of leucine is less than 8% of the total amount of amino
acids contained in the IDPN composition. In another embodiment, the
percentage of phenylalanine is more than 4% of the total amount of
amino acids contained in the IDPN composition. In another
embodiment, the percentage of histidine is less than 8% of the
total amount of amino acids contained in the IDPN composition. In
another embodiment, the percentage of histidine is less than 7% of
the total amount of amino acids contained in the IDPN composition.
In another embodiment, the percentage of methionine is more than 3%
of the total amount of amino acids contained in the IDPN
composition. In another embodiment, the percentage of alanine is
more than 8% of the total amount of amino acids contained in the
IDPN composition. In another embodiment, the percentage of alanine
is more than 9% of the total amount of amino acids contained in the
IDPN composition. In another embodiment, the percentage of alanine
is more than 10% of the total amount of amino acids contained in
the IDPN composition. In another embodiment, the percentage of
alanine is more than 11% of the total amount of amino acids
contained in the IDPN composition. In another embodiment, the
percentage of alanine is more than 12% of the total amount of amino
acids contained in the IDPN composition. In another embodiment, the
percentage of proline is more than 4% of the total amount of amino
acids contained in the IDPN composition. In another embodiment, the
percentage of proline is more than 5% of the total amount of amino
acids contained in the IDPN composition. In another embodiment, the
percentage of serine is less than 6% of the total amount of amino
acids contained in the IDPN composition. In another embodiment, the
IDPN composition comprises glutamic acid. In another embodiment,
the IDPN composition comprises aspartic acid.
[0087] In some instances, the effect of severe stress conditions is
the depletion of branched amino acids. In certain instances,
enriching the IDPN compositions with additional branched amino
acids results in the repletion or at least the partial repletion of
branched amino acids in a subject. In certain embodiments, an IDPN
composition comprises about 70%, about 65%, about 60%, about 55%,
about 50%, about 45%, about 40%, about 35%, about 30%, about 25%,
about 20%, about 15%, or about 10% branched amino acids of total
amino acids. In some embodiments, an IDPN composition comprises
more than 70%, more than 65%, more than 60%, more than 55%, more
than 50%, more than 45%, more than 40%, more than 35%, more than
30%, more than 25%, more than 20%, or more than 15% branched amino
acids of total amino acids. In some embodiments, an IDPN
composition comprises between 15% and 50% of branched-chain amino
acids of total amino acids. In other embodiments, an IDPN
composition comprises between 20% and 50% of branched-chain amino
acids of total amino acids. In other embodiments, an IDPN
composition comprises between 15% and 30% of branched-chain amino
acids of total amino acids. In other embodiments, an IDPN
composition comprises between 20% and 50% of branched-chain amino
acids of total amino acids. In some embodiments, branched-chain
amino acids comprise leucine, isoleucine, valine, or a combination
thereof. In certain embodiments, branched-chain amino acids
comprise leucine. In other embodiments, branched-chain amino acids
comprise isoleucine. In some embodiments, branched-chain amino
acids comprise valine. In certain embodiments, branched-chain amino
acids comprise valine and leucine. In other embodiments,
branched-chain amino acids comprise valine and isoleucine. In some
embodiments, branched-chain amino acids comprise leucine and
isoleucine. In other embodiments, branched-chain amino acids
comprise leucine, isoleucine, and valine. In certain embodiments,
branched-chain amino acids comprise unnatural branched amino
acids.
[0088] In one embodiment, the ratio of the amounts of amino acids
is optimized for nutritional value. In another embodiment, the
ratio of the amounts of amino acids is optimized for solubility. In
another embodiment, the ratio of the amounts of amino acids is
optimized for reduction of IDPN composition volume. In another
embodiment, the ratio of the amounts of amino acids is optimized
for administration.
[0089] In one embodiment, an IDPN composition is formulated from an
amino acid stock mixture. In another embodiment, an IDPN
composition comprises an amount of an amino acid stock mixture. In
another embodiment, an IDPN composition comprises a volume of an
amino acid stock mixture. In another embodiment, an amino acid
stock mixture is an amino acid stock solution. In another
embodiment, an IDPN composition comprises an amount of an amino
acid stock solution. In another embodiment, an IDPN composition
comprises a volume of an amino acid stock solution. In another
embodiment, an amino acid stock mixture is an aqueous solution. In
another embodiment, an amino acid stock mixture is a non-aqueous
mixture. In another embodiment, an amino acid stock mixture is a
non-aqueous solution. In another embodiment, an amino acid stock
mixture is a solid mixture. In another embodiment, an amino acid
stock mixture is a powder. In another embodiment, an amino acid
stock mixture is a gel. In another embodiment, an amino acid stock
mixture is a paste. In another embodiment, an amino acid stock
mixture is a concentrate, wherein the concentrate can be diluted to
a target concentration with a solvent, for example, water. In
another embodiment, an amino acid stock mixture is crystalline. In
another embodiment, an amino acid stock mixture is a heterogeneous
mixture. In another embodiment, an amino acid stock mixture is a
suspension. In another embodiment, an amino acid stock mixture
comprises 20 amino acids. In another embodiment, an amino acid
stock mixture comprises 17 amino acids. In another embodiment, an
amino acid stock mixture is a concentrated solution. In another
embodiment, an amino acid stock mixture has a reduced volume. In
another embodiment, an amino acid stock mixture comprises more than
about 2.5% amino acids on a mass/volume basis. In another
embodiment, an amino acid stock mixture comprises more than about
2.5% amino acids on a mass/mass basis. In another embodiment, an
amino acid stock mixture comprises less than about 50% amino acids
on a mass/volume basis. In another embodiment, an amino acid stock
mixture comprises less than about 50% amino acids on a mass/mass
basis. In another embodiment, an amino acid stock mixture comprises
less than about 40% amino acids on a mass/volume basis. In another
embodiment, an amino acid stock mixture comprises less than about
40% amino acids on a mass/mass basis. In another embodiment, an
amino acid stock mixture comprises less than about 30% amino acids
on a mass/volume basis. In another embodiment, an amino acid stock
mixture comprises less than about 30% amino acids on a mass/mass
basis. In another embodiment, an amino acid stock mixture comprises
less than about 25% amino acids on a mass/volume basis. In another
embodiment, an amino acid stock mixture comprises less than about
25% amino acids on a mass/mass basis. In another embodiment, an
amino acid stock mixture comprises from about 2.5% to about 50%
amino acids on a mass/volume basis. In another embodiment, an amino
acid stock mixture comprises from about 2.5% to about 50% amino
acids on a mass/mass basis. In another embodiment, an amino acid
stock mixture comprises from about 2.5% to about 40% amino acids on
a mass/volume basis. In another embodiment, an amino acid stock
mixture comprises from about 2.5% to about 40% amino acids on a
mass/mass basis. In another embodiment, an amino acid stock mixture
comprises from about 2.5% to about 30% amino acids on a mass/volume
basis. In another embodiment, an amino acid stock mixture comprises
from about 2.5% to about 30% amino acids on a mass/mass basis. In
another embodiment, an amino acid stock mixture comprises from
about 2.5% to about 25% amino acids on a mass/volume basis. In
another embodiment, an amino acid stock mixture comprises from
about 2.5% to about 25% amino acids on a mass/mass basis. In
another embodiment, an amino acid stock mixture comprises from
about 5% to about 20% amino acids on a mass/volume basis. In
another embodiment, an amino acid stock mixture comprises from
about 5% to about 20% amino acids on a mass/mass basis. In another
embodiment, an amino acid stock mixture comprises about 5% amino
acids on a mass/volume basis. In another embodiment, an amino acid
stock mixture comprises about 5% amino acids on a mass/mass basis.
In another embodiment, an amino acid stock solution comprises about
5% amino acids on a mass/volume basis. In another embodiment, an
amino acid stock solution comprises about 5% amino acids on a
mass/mass basis. In another embodiment, an amino acid stock mixture
comprises about 10% amino acids on a mass/volume basis. In another
embodiment, an amino acid stock mixture comprises about 10% amino
acids on a mass/mass basis. In another embodiment, an amino acid
stock solution comprises about 10% amino acids on a mass/volume
basis. In another embodiment, an amino acid stock solution
comprises about 10% amino acids on a mass/mass basis. In another
embodiment, an amino acid stock mixture comprises about 15% amino
acids on a mass/volume basis. In another embodiment, an amino acid
stock mixture comprises about 15% amino acids on a mass/mass basis.
In another embodiment, an amino acid stock solution comprises about
15% amino acids on a mass/volume basis. In another embodiment, an
amino acid stock solution comprises about 15% amino acids on a
mass/mass basis. In another embodiment, an amino acid stock mixture
comprises about 20% amino acids on a mass/volume basis. In another
embodiment, an amino acid stock mixture comprises about 20% amino
acids on a mass/mass basis. In another embodiment, an amino acid
stock solution comprises about 20% amino acids on a mass/volume
basis. In another embodiment, an amino acid stock solution
comprises about 20% amino acids on a mass/mass basis. In another
embodiment, an amino acid stock mixture comprises about 25% amino
acids on a mass/volume basis. In another embodiment, an amino acid
stock mixture comprises about 25% amino acids on a mass/mass basis.
In another embodiment, an amino acid stock solution comprises about
25% amino acids on a mass/volume basis. In another embodiment, an
amino acid stock solution comprises about 25% amino acids on a
mass/mass basis. In another embodiment, an amino acid stock mixture
comprises about 30% amino acids on a mass/volume basis. In another
embodiment, an amino acid stock mixture comprises about 30% amino
acids on a mass/mass basis. In another embodiment, an amino acid
stock solution comprises about 30% amino acids on a mass/volume
basis. In another embodiment, an amino acid stock solution
comprises about 30% amino acids on a mass/mass basis. In another
embodiment, an amino acid stock mixture comprises about 35% amino
acids on a mass/volume basis. In another embodiment, an amino acid
stock mixture comprises about 35% amino acids on a mass/mass basis.
In another embodiment, an amino acid stock solution comprises about
35% amino acids on a mass/volume basis. In another embodiment, an
amino acid stock solution comprises about 35% amino acids on a
mass/mass basis. In another embodiment, an amino acid stock mixture
comprises about 40% amino acids on a mass/volume basis. In another
embodiment, an amino acid stock mixture comprises about 40% amino
acids on a mass/mass basis. In another embodiment, an amino acid
stock solution comprises about 40% amino acids on a mass/volume
basis. In another embodiment, an amino acid stock solution
comprises about 40% amino acids on a mass/mass basis. In another
embodiment, an amino acid stock mixture comprises about 45% amino
acids on a mass/volume basis. In another embodiment, an amino acid
stock mixture comprises about 45% amino acids on a mass/mass basis.
In another embodiment, an amino acid stock solution comprises about
45% amino acids on a mass/volume basis. In another embodiment, an
amino acid stock solution comprises about 45% amino acids on a
mass/mass basis. In another embodiment, an amino acid stock mixture
comprises about 50% amino acids on a mass/volume basis. In another
embodiment, an amino acid stock mixture comprises about 50% amino
acids on a mass/mass basis. In another embodiment, an amino acid
stock solution comprises about 50% amino acids on a mass/volume
basis. In another embodiment, an amino acid stock solution
comprises about 50% amino acids on a mass/mass basis.
[0090] In one embodiment, an amino acid stock mixture comprising
15% amino acids on a mass/volume basis has the formulation
described in Table I.
TABLE-US-00001 TABLE I Amino Acids 15.0 g Total Nitrogen 2.37 g PH,
optionally adjusted with glacial 6.0 .+-. 1.0 acetic acid and/or
sodium hydroxide Lysine (from Lysine Acetate) 1.18 g Leucine 1.04 g
Phenylalanine 1.04 g Valine 960 mg Histidine 894 mg Isoleucine 749
mg Methionine 749 mg Threonine 749 mg Tryptophan 250 mg Alanine
2.17 g Arginine 1.47 g Glycine 1.04 g Proline 894 mg Glutamic Acid
749 mg Serine 592 mg Aspartic Acid 434 mg Tyrosine 39 mg Acetate
from Lysine Acetate and glacial 127 mEq acetic acid (balanced by
ions from amino acids) Osmolarity (Calculated) 1357 mOsmol/L Total
Volume, water being the balance of the volume 100 mL
[0091] In one embodiment, an amino acid stock mixture comprising
15% amino acids on a mass/volume basis has the formulation
described in Table II.
TABLE-US-00002 TABLE II Amino Acids 15.0 g Total Nitrogen 2.37 g
PH, optionally adjusted with glacial 6.0 .+-. 0.1 acetic acid
and/or sodium hydroxide Lysine (from Lysine Acetate) 1.18 g Leucine
1.04 g Phenylalanine 1.04 g Valine 960 mg Histidine 894 mg
Isoleucine 749 mg Methionine 749 mg Threonine 749 mg Tryptophan 250
mg Alanine 2.17 g Arginine 1.47 g Glycine 1.04 g Proline 894 mg
Glutamic Acid 749 mg Serine 592 mg Aspartic Acid 434 mg Tyrosine 39
mg Acetate from Lysine Acetate and glacial 127 mEq acetic acid
(balanced by ions from amino acids) Osmolarity (Calculated) 1357
mOsmol/L Total Volume, water being the balance of the volume 100
mL
[0092] In one embodiment, an amino acid stock mixture comprising
20% amino acids on a mass/volume basis has the formulation
described in Table II.
TABLE-US-00003 TABLE III Amino Acids 20.0 g Total Nitrogen 3.21 g
PH, optionally adjusted with glacial 6.0 .+-. 0.5 acetic acid
and/or sodium hydroxide Lysine (from Lysine Acetate) 1.35 g Leucine
1.08 g Phenylalanine 1.00 g Valine 1.44 g Histidine 1.18 mg
Isoleucine 1.08 mg Methionine 760 mg Threonine 980 mg Tryptophan
320 mg Alanine 2.76 g Arginine 1.96 g Glycine 2.06 g Proline 1.34 g
Glutamic Acid 1.02 g Serine 1.02 g Aspartic Acid 600 mg Tyrosine 50
mg Acetate from Lysine Acetate and glacial 140 mEq acetic acid
(balanced by ions from amino acids) Osmolarity (Calculated) 1835
mOsmol/L Total Volume, water being the balance of the volume 100
mL
[0093] In one embodiment, an amino acid stock mixture comprising
20% amino acids on a mass/volume basis has the formulation
described in Table IV.
TABLE-US-00004 TABLE IV Amino Acids 20.0 g Total Nitrogen 3.21 g
PH, optionally adjusted with glacial 6.0 .+-. 0.1 acetic acid
and/or sodium hydroxide Lysine (from Lysine Acetate) 1.35 g Leucine
1.08 g Phenylalanine 1.00 g Valine 1.44 g Histidine 1.18 mg
Isoleucine 1.08 mg Methionine 760 mg Threonine 980 mg Tryptophan
320 mg Alanine 2.76 g Arginine 1.96 g Glycine 2.06 g Proline 1.34 g
Glutamic Acid 1.02 g Serine 1.02 g Aspartic Acid 600 mg Tyrosine 50
mg Acetate from Lysine Acetate and glacial 140 mEq acetic acid
(balanced by ions from amino acids) Osmolarity (Calculated) 1835
mOsmol/L Total Volume, water being the balance of the volume 100
mL
[0094] In one embodiment, an amino acid stock mixture is
supplemented with branched chain amino acids. In one embodiment the
supplemented amino acid stock mixture comprises 20% branched chain
amino acids (such as 250 ml of Prosol supplemented with 250 ml of
Branchamine). In another embodiment an amino acid stock mixture is
supplemented with a branched chain amino acid solution listed in
Table V. In one embodiment an amino acid stock mixture is
supplemented with a branched chain amino acid solution by replacing
part of a first amino acid solution in the stock mixture with a
second amino acid solution (for example by adding a volume of
Branchamine or Nephrotect to Prosol). In another embodiment an
amino acid stock mixture is supplemented with a branched chain
amino acid solution by adding a second amino acid solution to a
first amino acid solution in a stock mixture (for example by adding
Fre-Amine HBC or Renamin to Prosol).
TABLE-US-00005 TABLE V Amino Acid Composition PROSOL and FRE-AMINE
BRANCHAMINE PROSOL NEPHROTECT HBC RENAMIN Volume 250 ml Prosol +
500 ml 500 ml 500 ml 500 ml 250 ml Branchamine Amino Leucine 6.15
5.4 5.8 g 6.85 3.0 Acids Isoleucine 6.15 5.4 12.8 g 3.8 2.5 Valine
6.7 7.2 8.7 g 4.4 4.1 Lysine 3.38 6.75 12 4.0 2.25 Methionine 1.9
3.8 2.0 1.0 2.5 Phenylalanine 2.5 5.0 3.5 1.6 2.45 Threonine 2.45
1.47 3.5 1.0 1.9 Tryptophan .8 1.6 3.0 .45 .8 Arginine 4.9 9.8 8.2
2.9 3.15 Histidine 2.95 5.9 6.2 .8 2.1 Alanine 6.9 13.8 9.8 2.0 2.8
Glycine 5.15 10.3 5.31 1.65 1.5 Proline 3.35 6.7 3.0 3.15 1.75
Serine 2.55 5.1 7.6 1.65 1.5 Tyrosine .125 0.25 .60 0.20
[0095] In one embodiment, the percentage of lysine is less than 10%
of the total amount of amino acids contained in the amino acid
stock solution. In another embodiment, the percentage of lysine is
less than 11% of the total amount of amino acids contained in the
amino acid stock solution. In another embodiment, the percentage of
lysine is less than 12% of the total amount of amino acids
contained in the amino acid stock solution. In another embodiment,
the percentage of lysine is less than 13% of the total amount of
amino acids contained in the amino acid stock solution. In another
embodiment, the percentage of lysine is less than 14% of the total
amount of amino acids contained in the amino acid stock solution.
In another embodiment, the percentage of lysine is less than 15% of
the total amount of amino acids contained in the amino acid stock
solution. In another embodiment, the percentage of leucine is less
than 10% of the total amount of amino acids contained in the amino
acid stock solution. In another embodiment, the percentage of
leucine is less than 11% of the total amount of amino acids
contained in the amino acid stock solution. In another embodiment,
the percentage of leucine is less than 12% of the total amount of
amino acids contained in the amino acid stock solution. In another
embodiment, the percentage of leucine is less than 9% of the total
amount of amino acids contained in the amino acid stock solution.
In another embodiment, the percentage of leucine is less than 8% of
the total amount of amino acids contained in the amino acid stock
solution. In another embodiment, the percentage of phenylalanine is
more than 4% of the total amount of amino acids contained in the
Amino acid stock solution. In another embodiment, the percentage of
histidine is less than 8% of the total amount of amino acids
contained in the Amino acid stock solution. In another embodiment,
the percentage of histidine is less than 7% of the total amount of
amino acids contained in the Amino acid stock solution. In another
embodiment, the percentage of methionine is more than 3% of the
total amount of amino acids contained in the Amino acid stock
solution. In another embodiment, the percentage of alanine is more
than 8% of the total amount of amino acids contained in the Amino
acid stock solution. In another embodiment, the percentage of
alanine is more than 9% of the total amount of amino acids
contained in the Amino acid stock solution. In another embodiment,
the percentage of alanine is more than 10% of the total amount of
amino acids contained in the Amino acid stock solution. In another
embodiment, the percentage of alanine is more than 11% of the total
amount of amino acids contained in the Amino acid stock solution.
In another embodiment, the percentage of alanine is more than 12%
of the total amount of amino acids contained in the Amino acid
stock solution. In another embodiment, the percentage of proline is
more than 4% of the total amount of amino acids contained in the
Amino acid stock solution. In another embodiment, the percentage of
proline is more than 5% of the total amount of amino acids
contained in the Amino acid stock solution. In another embodiment,
the percentage of serine is less than 6% of the total amount of
amino acids contained in the Amino acid stock solution. In another
embodiment, the amino acid stock solution comprises glutamic acid.
In another embodiment, the amino acid stock solution comprises
aspartic acid.
[0096] In some instances, the effect of severe stress conditions is
the depletion of branched amino acids. In certain instances,
enriching the amino acid stock mixtures, e.g., the stock mixtures
of Tables I-IV, with additional branched amino acids results in the
repletion or at least the partial repletion of branched amino acids
in a subject. In some embodiments, a stressed subject can safely
utilize up to 1.4 g/kg/day of a 50% branched amino acid
supplemented solution. In certain embodiments, a branched amino
acid enriched amino acid stock mixture comprises about 70%, about
65%, about 60%, about 55%, about 50%, about 45%, about 40%, about
35%, about 30%, about 25%, about 20%, about 15%, or about 10%
branched amino acids of total amino acids. In some embodiments, a
branched amino acid enriched amino acid stock mixture comprises
between 15% and 50% of branched-chain amino acids of total amino
acids. In other embodiments, a branched amino acid enriched amino
acid stock mixture comprises between 20% and 50% of branched-chain
amino acids of total amino acids. In other embodiments, a branched
amino acid enriched amino acid stock mixture comprises between 15%
and 30% of branched-chain amino acids of total amino acids. In
other embodiments, a branched amino acid enriched amino acid stock
mixture comprises between 20% and 50% of branched-chain amino acids
of total amino acids. In some embodiments, branched amino acids
comprise leucine, isoleucine, valine, or a combination thereof. In
certain embodiments, branched amino acids comprise leucine. In
other embodiments, branched amino acids comprise isoleucine. In
some embodiments, branched amino acids comprise valine. In certain
embodiments, branched amino acids comprise valine and leucine. In
other embodiments, branched amino acids comprise valine and
isoleucine. In some embodiments, branched amino acids comprise
leucine and isoleucine. In other embodiments, branched amino acids
comprise leucine, isoleucine, and valine. In certain embodiments,
branched amino acids comprise unnatural branched amino acids.
[0097] In one embodiment, a branched amino acid supplement is
introduced into an amino acid stock mixture by adding to an amino
acid stock mixture an amount of a stock branched amino acid
supplement solution. In another embodiment, a branched amino acid
supplement is introduced into an amino acid stock mixture by adding
to an amino acid stock mixture a volume of a stock branched amino
acid supplement solution. In one embodiment, a branched amino acid
supplement is introduced into an IDPN composition by adding to an
IDPN composition an amount of a stock branched amino acid
supplement solution. In another embodiment, a branched amino acid
supplement is introduced into an IDPN composition by adding to an
IDPN composition a volume of a stock branched amino acid supplement
solution.
[0098] In another embodiment, a stock branched amino acid
supplement solution has a branched amino acid concentration of at
least about 1% on a mass/volume basis. In another embodiment, a
stock branched amino acid supplement solution has a branched amino
acid concentration of at least about 1% on a mass/mass basis. In
another embodiment, a stock branched amino acid supplement solution
has a branched amino acid concentration of at least about 2% on a
mass/volume basis. In another embodiment, a stock branched amino
acid supplement solution has a branched amino acid concentration of
at least about 2% on a mass/mass basis. In another embodiment, a
stock branched amino acid supplement solution has a branched amino
acid concentration of at least about 3% on a mass/volume basis. In
another embodiment, a stock branched amino acid supplement solution
has a branched amino acid concentration of at least about 3% on a
mass/mass basis. In another embodiment, a stock branched amino acid
supplement solution has a branched amino acid concentration of at
least about 4% on a mass/volume basis. In another embodiment, a
stock branched amino acid supplement solution has a branched amino
acid concentration of at least about 4% on a mass/mass basis. In
another embodiment, a stock branched amino acid supplement solution
has a branched amino acid concentration of at least about 5% on a
mass/volume basis. In another embodiment, a stock branched amino
acid supplement solution has a branched amino acid concentration of
at least about 5% on a mass/mass basis. In another embodiment, a
stock branched amino acid supplement solution has a branched amino
acid concentration of at least about 7.5% on a mass/volume basis.
In another embodiment, a stock branched amino acid supplement
solution has a branched amino acid concentration of at least about
7.5% on a mass/mass basis. In another embodiment, a stock branched
amino acid supplement solution has a branched amino acid
concentration of at least about 10% on a mass/volume basis. In
another embodiment, a stock branched amino acid supplement solution
has a branched amino acid concentration of at least about 10% on a
mass/mass basis. In another embodiment, a stock branched amino acid
supplement solution has a branched amino acid concentration of at
least about 15% on a mass/volume basis. In another embodiment, a
stock branched amino acid supplement solution has a branched amino
acid concentration of at least about 15% on a mass/mass basis. In
another embodiment, a stock branched amino acid supplement solution
has a branched amino acid concentration of at least about 20% on a
mass/volume basis. In another embodiment, a stock branched amino
acid supplement solution has a branched amino acid concentration of
at least about 20% on a mass/mass basis. In another embodiment, a
stock branched amino acid supplement solution has a branched amino
acid concentration of at least about 25% on a mass/volume basis. In
another embodiment, a stock branched amino acid supplement solution
has a branched amino acid concentration of at least about 25% on a
mass/mass basis. In another embodiment, a stock branched amino acid
supplement solution has a branched amino acid concentration of at
least about 30% on a mass/volume basis. In another embodiment, a
stock branched amino acid supplement solution has a branched amino
acid concentration of at least about 30% on a mass/mass basis. In
another embodiment, a stock branched amino acid supplement solution
has a branched amino acid concentration of at least about 35% on a
mass/volume basis. In another embodiment, a stock branched amino
acid supplement solution has a branched amino acid concentration of
at least about 35% on a mass/mass basis. In another embodiment, a
stock branched amino acid supplement solution has a branched amino
acid concentration of at least about 40% on a mass/volume basis. In
another embodiment, a stock branched amino acid supplement solution
has a branched amino acid concentration of at least about 40% on a
mass/mass basis. In another embodiment, a stock branched amino acid
supplement solution has a branched amino acid concentration of from
about 1% to about 5% on a mass/volume basis. In another embodiment,
a stock branched amino acid supplement solution has a branched
amino acid concentration of from about 1% to about 5% on a
mass/mass basis. In another embodiment, a stock branched amino acid
supplement solution has a branched amino acid concentration of from
about 1% to about 10% on a mass/volume basis. In another
embodiment, a stock branched amino acid supplement solution has a
branched amino acid concentration of from about 1% to about 10% on
a mass/mass basis. In another embodiment, a stock branched amino
acid supplement solution has a branched amino acid concentration of
from about 1% to about 15% on a mass/volume basis. In another
embodiment, a stock branched amino acid supplement solution has a
branched amino acid concentration of from about 1% to about 15% on
a mass/mass basis. In another embodiment, a stock branched amino
acid supplement solution has a branched amino acid concentration of
from about 1% to about 20% on a mass/volume basis. In another
embodiment, a stock branched amino acid supplement solution has a
branched amino acid concentration of from about 1% to about 20% on
a mass/mass basis. In another embodiment, a stock branched amino
acid supplement solution has a branched amino acid concentration of
from about 1% to about 25% on a mass/volume basis. In another
embodiment, a stock branched amino acid supplement solution has a
branched amino acid concentration of from about 1% to about 25% on
a mass/mass basis. In another embodiment, a stock branched amino
acid supplement solution has a branched amino acid concentration of
from about 10% to about 30% on a mass/volume basis. In another
embodiment, a stock branched amino acid supplement solution has a
branched amino acid concentration of from about 10% to about 30% on
a mass/mass basis. In another embodiment, a stock branched amino
acid supplement solution has a branched amino acid concentration of
from about 10% to about 40% on a mass/volume basis. In another
embodiment, a stock branched amino acid supplement solution has a
branched amino acid concentration of from about 10% to about 40% on
a mass/mass basis. In another embodiment, a stock branched amino
acid supplement solution has a branched amino acid supplement
concentration of about 1%, about 2%, about 3%, about 4%, about 5%,
about 7.5%, about 10%, about 15%, about 20%, about 25%, about 30%,
about 35%, or about 40% on a mass/volume basis. In another
embodiment, a stock branched amino acid supplement solution has a
branched amino acid supplement concentration of about 1%, about 2%,
about 3%, about 4%, about 5%, about 7.5%, about 10%, about 15%,
about 20%, about 25%, about 30%, about 35%, or about 40% on a
mass/mass basis.
[0099] In another embodiment, a branched amino acid supplement is
an aqueous solution. In another embodiment, a branched amino acid
supplement is a non-aqueous mixture. In another embodiment, a
branched amino acid supplement is a non-aqueous solution. In
another embodiment, a branched amino acid supplement is a solid
mixture. In another embodiment, a branched amino acid supplement is
a powder. In another embodiment, a branched amino acid supplement
is a gel. In another embodiment, a branched amino acid supplement
is a paste. In another embodiment, a branched amino acid supplement
is a concentrate, wherein the concentrate can be diluted to a
target concentration with a solvent, for example, water. In another
embodiment, a branched amino acid supplement is crystalline. In
another embodiment, a branched amino acid supplement is a
heterogeneous mixture. In another embodiment, a branched amino acid
supplement is a suspension. In another embodiment, a branched amino
acid supplement is a concentrated solution. In another embodiment,
a branched amino acid supplement has a reduced volume.
[0100] In another embodiment, a branched amino acid supplement is a
powder for reconstitution. In some embodiments, the powder for
reconstitution comprising the branched amino acid supplement is
dissolved and the aqueous solution mixed with the IDPN composition.
In other embodiments, the powder for reconstitution comprising the
branched amino acid supplements is dissolved in the IDPN solution.
In some embodiments, the powder for reconstitution comprising the
branched amino acid supplement is dissolved and the aqueous
solution mixed with an amino acid stock solution. In further
embodiments, the powder for reconstitution comprising the branched
amino acid supplements is dissolved in an amino acid stock
solution. In one embodiment, a branched amino acid supplement is
introduced into an amino acid stock mixture by adding to an amino
acid stock mixture an amount of a branched amino acid supplement
powder for reconstitution. In one embodiment, a branched amino acid
supplement is introduced into an IDPN composition by adding to an
IDPN composition an amount of a branched amino acid supplement
powder for reconstitution
[0101] In one embodiment, an IDPN composition comprises less than
about 1 g/mL of dextrose. In another embodiment, an IDPN
composition comprises less than about 0.5 g/mL of dextrose. In
another embodiment, an IDPN composition comprises less than about
0.25 g/mL of dextrose. In another embodiment, an IDPN composition
comprises less than about 0.1 g/mL of dextrose. In another
embodiment, an IDPN composition comprises more than about 0.02 g/mL
of dextrose. In another embodiment, an IDPN composition comprises
more than about 0.03 g/mL of dextrose. In another embodiment, an
IDPN composition comprises more than about 0.04 g/mL of dextrose.
In another embodiment, an IDPN composition comprises more than
about 0.05 g/mL of dextrose. In another embodiment, an IDPN
composition comprises more than about 0.1 g/mL of dextrose. In
another embodiment, an IDPN composition comprises between about
0.02 and about 0.10 g/mL of dextrose. In another embodiment, an
IDPN composition comprises between about 0.04 and about 0.08 g/mL
of dextrose. In another embodiment, an IDPN composition comprises
between about 0.05 and about 0.07 g/mL of dextrose. In another
embodiment, an IDPN composition comprises between about 0.055 and
about 0.065 g/mL of dextrose. In another embodiment, an IDPN
comprises about 0.02, about 0.03, about 0.04, about 0.05, about
0.06, about 0.07, about 0.08, about 0.09 or about 0.10 g/mL of
dextrose. In another embodiment, an IDPN composition comprises
about 0.055, about 0.056, about 0.057, about 0.058, about 0.059,
about 0.060, about 0.061, about 0.062, about 0.063, about 0.064 or
about 0.065 g/mL of dextrose.
[0102] In one embodiment, the IDPN composition is free of
carbohydrates. In another embodiments, the IDPN composition is
essentially free of carbohydrates. In another embodiment, the IDPN
composition is free of dextrose, fructose, sucrose, lactose,
galactose, mannose, maltose, ribose, arabinose, sorbose,
glyceraldehydes, or glycerol. In other embodiment, the IDPN
composition is essentially free of dextrose, fructose, sucrose,
lactose, galactose, mannose, maltose, ribose, arabinose, sorbose,
glyceraldehydes, or glycerol. In another embodiment, the IDPN is
free of dextrose. In another embodiment, the IDPN is essentially
free of dextrose. In another embodiment, the IDPN is free of
fructose. In another embodiment, the IDPN is essentially free of
fructose. In another embodiment, the IDPN is free of sucrose. In
another embodiment, the IDPN is essentially free of sucrose. In
another embodiment, the IDPN is free of lactose. In another
embodiment, the IDPN is essentially free of lactose. In another
embodiment, the IDPN is free of galactose. In another embodiment,
the IDPN is essentially free of galactose. In another embodiment,
the IDPN is free of mannose. In another embodiment, the IDPN is
essentially free of mannose. In another embodiment, the IDPN is
free of maltose. In another embodiment, the IDPN is essentially
free of maltose. In another embodiment, the IDPN is free of ribose.
In another embodiment, the IDPN is essentially free of ribose. In
another embodiment, the IDPN is free of arabinose. In another
embodiment, the IDPN is essentially free of arabinose. In another
embodiment, the IDPN is free of sorbose. In another embodiment, the
IDPN is essentially free of sorbose. In another embodiment, the
IDPN is free of glyceraldehyde. In another embodiment, the IDPN is
essentially free of glyceraldehyde. In another embodiment, the IDPN
is free of glycerol. In another embodiment, the IDPN is essentially
free of glycerol.
[0103] In one embodiment, a carbohydrate is introduced into an IDPN
composition by adding to an IDPN composition an amount of a stock
carbohydrate solution. In another embodiment, a carbohydrate is
introduced into an IDPN composition by adding to an IDPN
composition a volume of a stock carbohydrate solution. In another
embodiment, a stock carbohydrate solution has a carbohydrate
concentration of at least about 10% on a mass/volume basis. In
another embodiment, a stock carbohydrate solution has a
carbohydrate concentration of at least about 10% on a mass/mass
basis. In another embodiment, a stock carbohydrate solution has a
carbohydrate concentration of at least about 20% on a mass/volume
basis. In another embodiment, a stock carbohydrate solution has a
carbohydrate concentration of at least about 20% on a mass/mass
basis. In another embodiment, a stock carbohydrate solution has a
carbohydrate concentration of at least about 30% on a mass/volume
basis. In another embodiment, a stock carbohydrate solution has a
carbohydrate concentration of at least about 30% on a mass/mass
basis. In another embodiment, a stock carbohydrate solution has a
carbohydrate concentration of at least about 40% on a mass/volume
basis. In another embodiment, a stock carbohydrate solution has a
carbohydrate concentration of at least about 40% on a mass/mass
basis. In another embodiment, a stock carbohydrate solution has a
carbohydrate concentration of at least about 50% on a mass/volume
basis. In another embodiment, a stock carbohydrate solution has a
carbohydrate concentration of at least about 50% on a mass/mass
basis. In another embodiment, a stock carbohydrate solution has a
carbohydrate concentration of at least about 60% on a mass/volume
basis. In another embodiment, a stock carbohydrate solution has a
carbohydrate concentration of at least about 60% on a mass/mass
basis. In another embodiment, a stock carbohydrate solution has a
carbohydrate concentration of at least about 70% on a mass/volume
basis. In another embodiment, a stock carbohydrate solution has a
carbohydrate concentration of at least about 70% on a mass/mass
basis. In another embodiment, a stock carbohydrate solution has a
carbohydrate concentration of less than about 80% on a mass/volume
basis. In another embodiment, a stock carbohydrate solution has a
carbohydrate concentration of less than about 80% on a mass/mass
basis. In another embodiment, a stock carbohydrate solution has a
carbohydrate concentration of from about 10% to about 80% on a
mass/volume basis. In another embodiment, a stock carbohydrate
solution has a carbohydrate concentration of from about 10% to
about 80% on a mass/mass basis. In another embodiment, a stock
carbohydrate solution has a carbohydrate concentration of from
about 20% to about 80% on a mass/volume basis. In another
embodiment, a stock carbohydrate solution has a carbohydrate
concentration of from about 20% to about 80% on a mass/mass basis.
In another embodiment, a stock carbohydrate solution has a
carbohydrate concentration of from about 40% to about 80% on a
mass/volume basis. In another embodiment, a stock carbohydrate
solution has a carbohydrate concentration of from about 40% to
about 80% on a mass/mass basis. In another embodiment, a stock
carbohydrate solution has a carbohydrate concentration of from
about 60% to about 80% on a mass/volume basis. In another
embodiment, a stock carbohydrate solution has a carbohydrate
concentration of from about 60% to about 80% on a mass/mass basis.
In another embodiment, a stock carbohydrate solution has a
carbohydrate concentration of about 5%, about 10%, about 15%, about
20%, about 25%, about 30%, about 35%, about 40%, about 45%, about
50%, about 55%, about 60%, about 65%, about 70%, about 75%, or
about 80% on a mass/volume basis. In another embodiment, a stock
carbohydrate solution has a carbohydrate concentration of from
about 60% to about 80% on a mass/mass basis. In another embodiment,
a stock carbohydrate solution has a carbohydrate concentration of
about 5%, about 10%, about 15%, about 20%, about 25%, about 30%,
about 35%, about 40%, about 45%, about 50%, about 55%, about 60%,
about 65%, about 70%, about 75%, or about 80% on a mass/mass basis.
In another embodiment, a stock carbohydrate solution has a
carbohydrate concentration of about 70% on a mass/volume basis. In
another embodiment, a stock carbohydrate solution has a
carbohydrate concentration of about 70% on a mass/mass basis. In
another embodiment, the carbohydrate of the stock carbohydrate
solution is dextrose. In another embodiment, a stock carbohydrate
solution has a dextrose concentration of at least about 10% on a
mass/volume basis. In another embodiment, a stock carbohydrate
solution has a dextrose concentration of at least about 10% on a
mass/mass basis. In another embodiment, a stock carbohydrate
solution has a dextrose concentration of at least about 20% on a
mass/volume basis. In another embodiment, a stock carbohydrate
solution has a dextrose concentration of at least about 20% on a
mass/mass basis. In another embodiment, a stock carbohydrate
solution has a dextrose concentration of at least about 30% on a
mass/volume basis. In another embodiment, a stock carbohydrate
solution has a dextrose concentration of at least about 30% on a
mass/mass basis. In another embodiment, a stock carbohydrate
solution has a dextrose concentration of at least about 40% on a
mass/volume basis. In another embodiment, a stock carbohydrate
solution has a dextrose concentration of at least about 40% on a
mass/mass basis. In another embodiment, a stock carbohydrate
solution has a dextrose concentration of at least about 50% on a
mass/volume basis. In another embodiment, a stock carbohydrate
solution has a dextrose concentration of at least about 50% on a
mass/mass basis. In another embodiment, a stock carbohydrate
solution has a dextrose concentration of at least about 60% on a
mass/volume basis. In another embodiment, a stock carbohydrate
solution has a dextrose concentration of at least about 60% on a
mass/mass basis. In another embodiment, a stock carbohydrate
solution has a dextrose concentration of at least about 70% on a
mass/volume basis. In another embodiment, a stock carbohydrate
solution has a dextrose concentration of at least about 70% on a
mass/mass basis. In another embodiment, a stock carbohydrate
solution has a dextrose concentration of less than about 80% on a
mass/volume basis. In another embodiment, a stock carbohydrate
solution has a dextrose concentration of less than about 80% on a
mass/mass basis. In another embodiment, a stock carbohydrate
solution has a dextrose concentration of from about 10% to about
80% on a mass/volume basis. In another embodiment, a stock
carbohydrate solution has a dextrose concentration of from about
10% to about 80% on a mass/mass basis. In another embodiment, a
stock carbohydrate solution has a dextrose concentration of from
about 20% to about 80% on a mass/volume basis. In another
embodiment, a stock carbohydrate solution has a dextrose
concentration of from about 20% to about 80% on a mass/mass basis.
In another embodiment, a stock carbohydrate solution has a dextrose
concentration of from about 40% to about 80% on a mass/volume
basis. In another embodiment, a stock carbohydrate solution has a
dextrose concentration of from about 40% to about 80% on a
mass/mass basis. In another embodiment, a stock carbohydrate
solution has a dextrose concentration of from about 60% to about
80% on a mass/volume basis. In another embodiment, a stock
carbohydrate solution has a dextrose concentration of from about
60% to about 80% on a mass/mass basis. In another embodiment, a
stock carbohydrate solution has a dextrose concentration of about
5%, about 10%, about 15%, about 20%, about 25%, about 30%, about
35%, about 40%, about 45%, about 50%, about 55%, about 60%, about
65%, about 70%, about 75%, or about 80% on a mass/volume basis. In
another embodiment, a stock carbohydrate solution has a dextrose
concentration of about 5%, about 10%, about 15%, about 20%, about
25%, about 30%, about 35%, about 40%, about 45%, about 50%, about
55%, about 60%, about 65%, about 70%, about 75%, or about 80% on a
mass/mass basis. In another embodiment, a stock carbohydrate
solution has a dextrose concentration of about 70% on a mass/volume
basis. In another embodiment, a stock carbohydrate solution has a
dextrose concentration of about 70% on a mass/mass basis.
[0104] In one embodiment, an IDPN composition comprises a lipid. In
another embodiment, an IDPN composition comprises greater than
about 0.001 g/mL of lipids. In another embodiment, an IDPN
composition comprises greater than about 0.005 g/mL of lipids. In
another embodiment, an IDPN composition comprises greater than
about 0.01 g/mL of lipids. In another embodiment, an IDPN
composition comprises greater than about 0.02 g/mL of lipids. In
another embodiment, an IDPN composition comprises less than about
0.10 g/mL of lipids. In another embodiment, an IDPN composition
comprises less than about 0.05 g/mL of lipids. In another
embodiment, an IDPN composition comprises less than about 0.03 g/mL
of lipids. In another embodiment, an IDPN composition comprises
from about 0.001 g/mL to about 0.10 g/mL of lipids. In another
embodiment, an IDPN composition comprises from about 0.01 g/mL to
about 0.05 g/mL of lipids. In another embodiment, an IDPN
composition comprises from about 0.015 g/mL to about 0.035 g/mL of
lipids. In another embodiment, an IDPN composition comprises from
about 0.02 g/mL to about 0.03 g/mL of lipids. In another
embodiment, an IDPN composition comprises about 0.010 g/mL, about
0.011 g/mL, about 0.012 g/mL, about 0.013 g/mL, about 0.014 g/mL,
about 0.015 g/mL, about 0.016 g/mL, about 0.017 g/mL, about 0.018
g/mL, about 0.019 g/mL, about 0.020 g/mL, about 0.021 g/mL, about
0.022 g/mL, about 0.023 g/mL, about 0.024 g/mL, about 0.025 g/mL,
about 0.026 g/mL, about 0.027 g/mL, about 0.028 g/mL, about 0.029
g/mL, about 0.030 g/mL, about 0.031 g/mL, about 0.032 g/mL, about
0.033 g/mL, about 0.034 g/mL, about 0.035 g/mL, about 0.036 g/mL,
about 0.037 g/mL, about 0.038 g/mL, about 0.039 g/mL, about 0.040
g/mL, about 0.041 g/mL, about 0.042 g/mL, about 0.043 g/mL, about
0.044 g/mL, about 0.045 g/mL, about 0.046 g/mL, about 0.047 g/mL,
about 0.048 g/mL, about 0.049 g/mL, or about 0.050 g/mL of
lipids.
[0105] In one embodiment, an IDPN composition is lipid-free. In
another embodiment, an IDPN composition is essentially lipid-free.
In another embodiment, an IDPN composition comprises less than 10%
mass/volume, less than 9% mass/volume, less than 8% mass/volume,
less than 7% mass/volume, less than 6% mass/volume, less than 5%
mass/volume, less than 4% mass/volume, less than 3% mass/volume,
less than 2% mass/volume, less than 1% mass/volume, less than 0.9%
mass/volume, less than 0.8% mass/volume, less than 0.7%
mass/volume, less than 0.6% mass/volume, less than 0.5%
mass/volume, less than 0.4% mass/volume, less than 0.3%
mass/volume, less than 0.2% mass/volume, less than 0.1% mass/volume
of lipids. In another embodiment, an IDPN composition comprises
between about 5% and about 10% mass/volume of lipids. In another
embodiment, an IDPN composition comprises between about 0.1% and
about 1% mass/volume of lipids. In another embodiment, an IDPN
composition comprises between about 1% and about 5% mass/volume of
lipids. In another embodiment, an IDPN composition comprises
between about 0.5% and about 3% mass/volume of lipids. In another
embodiment, an IDPN composition comprises between about 1% and
about 6% mass/volume of lipids. In another embodiment, an IDPN
composition comprises less than 10% mass/mass, less than 9%
mass/mass, less than 8% mass/mass, less than 7% mass/mass, less
than 6% mass/mass, less than 5% mass/mass, less than 4% mass/mass,
less than 3% mass/mass, less than 2% mass/mass, less than 1%
mass/mass, less than 0.9% mass/mass, less than 0.8% mass/mass, less
than 0.7% mass/mass, less than 0.6% mass/mass, less than 0.5%
mass/mass, less than 0.4% mass/mass, less than 0.3% mass/mass, less
than 0.2% mass/mass, less than 0.1% mass/mass of lipids. In another
embodiment, an IDPN composition comprises between about 5% and
about 10% mass/mass of lipids. In another embodiment, an IDPN
composition comprises between about 0.1% and about 1% mass/mass of
lipids. In another embodiment, an IDPN composition comprises
between about 1% and about 5% mass/mass of lipids. In another
embodiment, an IDPN composition comprises between about 0.5% and
about 3% mass/mass of lipids. In another embodiment, an IDPN
composition comprises between about 1% and about 6% mass/mass of
lipids.
[0106] In one embodiment, a lipid is introduced into an IDPN
composition by adding to an IDPN composition an amount of a stock
lipid mixture. In another embodiment, a lipid stock mixture is a
solution. In another embodiment, a lipid stock mixture is an
aqueous solution. In another embodiment, a lipid stock mixture is a
non-aqueous mixture. In another embodiment, a lipid stock mixture
is a non-aqueous solution. In another embodiment, a lipid stock
mixture is a solid mixture. In another embodiment, a lipid stock
mixture is a powder. In another embodiment, a lipid stock mixture
is a gel. In another embodiment, a lipid stock mixture is a paste.
In another embodiment, a lipid stock mixture is a concentrate,
wherein the concentrate can be diluted to a target concentration
with a solvent, for example, water. In another embodiment, a lipid
stock mixture is crystalline. In another embodiment, a lipid stock
mixture is a heterogeneous mixture. In another embodiment, a lipid
stock mixture is a suspension. In another embodiment, a lipid stock
mixture is an emulsion. In another embodiment, a lipid stock
mixture comprises a fat-soluble vitamin, for example, vitamin
D.
[0107] In another embodiment, a lipid stock mixture comprises
greater than about 2.5% lipids on a mass/volume basis. In another
embodiment, a lipid stock mixture comprises greater than about 2.5%
lipids on a mass/mass basis. In another embodiment, a lipid stock
mixture comprises greater than about 2.5% lipids on a volume/volume
basis. In another embodiment, a lipid stock solution comprises
greater than about 2.5% lipids on a mass/volume basis. In another
embodiment, a lipid stock solution comprises greater than about
2.5% lipids on a mass/mass basis. In another embodiment, a lipid
stock solution comprises greater than about 2.5% lipids on a
volume/volume basis. In another embodiment, a lipid stock mixture
comprises greater than about 5% lipids on a mass/volume basis. In
another embodiment, a lipid stock mixture comprises greater than
about 5% lipids on a mass/mass basis. In another embodiment, a
lipid stock mixture comprises greater than about 5% lipids on a
volume/volume basis. In another embodiment, a lipid stock solution
comprises greater than about 5% lipids on a mass/volume basis. In
another embodiment, a lipid stock solution comprises greater than
about 5% lipids on a mass/mass basis. In another embodiment, a
lipid stock solution comprises greater than about 5% lipids on a
volume/volume basis. In another embodiment, a lipid stock mixture
comprises less than about 70% lipids on a mass/volume basis. In
another embodiment, a lipid stock mixture comprises less than about
70% lipids on a mass/mass basis. In another embodiment, a lipid
stock mixture comprises less than about 70% lipids on a
volume/volume basis. In another embodiment, a lipid stock solution
comprises less than about 70% lipids on a mass/volume basis. In
another embodiment, a lipid stock solution comprises less than
about 70% lipids on a mass/mass basis. In another embodiment, a
lipid stock solution comprises less than about 70% lipids on a
volume/volume basis. In another embodiment, a lipid stock mixture
comprises less than about 60% lipids on a mass/volume basis. In
another embodiment, a lipid stock mixture comprises less than about
60% lipids on a mass/mass basis. In another embodiment, a lipid
stock mixture comprises less than about 60% lipids on a
volume/volume basis. In another embodiment, a lipid stock solution
comprises less than about 60% lipids on a mass/volume basis. In
another embodiment, a lipid stock solution comprises less than
about 60% lipids on a mass/mass basis. In another embodiment, a
lipid stock solution comprises less than about 60% lipids on a
volume/volume basis. In another embodiment, a lipid stock mixture
comprises from about 2.5% to about 70% lipids on a mass/volume
basis. In another embodiment, a lipid stock mixture comprises from
about 2.5% to about 70% lipids on a mass/mass basis. In another
embodiment, a lipid stock mixture comprises from about 2.5% to
about 70% lipids on a volume/volume basis. In another embodiment, a
lipid stock solution comprises from about 2.5% to about 70% lipids
on a mass/volume basis. In another embodiment, a lipid stock
solution comprises from about 2.5% to about 70% lipids on a
mass/mass basis. In another embodiment, a lipid stock solution
comprises from about 2.5% to about 70% lipids on a volume/volume
basis. In another embodiment, a lipid stock mixture comprises from
about 5% to about 50% lipids on a mass/volume basis. In another
embodiment, a lipid stock mixture comprises from about 5% to about
50% lipids on a mass/mass basis. In another embodiment, a lipid
stock mixture comprises from about 5% to about 50% lipids on a
volume/volume basis. In another embodiment, a lipid stock solution
comprises from about 5% to about 50% lipids on a mass/volume basis.
In another embodiment, a lipid stock solution comprises from about
5% to about 50% lipids on a mass/mass basis. In another embodiment,
a lipid stock solution comprises from about 5% to about 50% lipids
on a volume/volume basis. In another embodiment, a lipid stock
mixture comprises from about 10% to about 30% lipids on a
mass/volume basis. In another embodiment, a lipid stock mixture
comprises from about 10% to about 30% lipids on a mass/mass basis.
In another embodiment, a lipid stock mixture comprises from about
10% to about 30% lipids on a volume/volume basis. In another
embodiment, a lipid stock solution comprises from about 10% to
about 30% lipids on a mass/volume basis. In another embodiment, a
lipid stock solution comprises from about 10% to about 30% lipids
on a mass/mass basis. In another embodiment, a lipid stock solution
comprises 1 from about 10% to about 30% lipids on a volume/volume
basis. In another embodiment, a lipid stock mixture comprises about
5% lipids on a mass/volume basis. In another embodiment, a lipid
stock mixture comprises about 5% lipids on a mass/mass basis. In
another embodiment, a lipid stock mixture comprises about 5% lipids
on a volume/volume basis. In another embodiment, a lipid stock
solution comprises about 5% lipids on a mass/volume basis. In
another embodiment, a lipid stock solution comprises about 5%
lipids on a mass/mass basis. In another embodiment, a lipid stock
solution comprises about 5% lipids on a volume/volume basis. In
another embodiment, a lipid stock mixture comprises about 10%
lipids on a mass/volume basis. In another embodiment, a lipid stock
mixture comprises about 10% lipids on a mass/mass basis. In another
embodiment, a lipid stock mixture comprises about 10% lipids on a
volume/volume basis. In another embodiment, a lipid stock solution
comprises about 10% lipids on a mass/volume basis. In another
embodiment, a lipid stock solution comprises about 10% lipids on a
mass/mass basis. In another embodiment, a lipid stock solution
comprises about 10% lipids on a volume/volume basis. In another
embodiment, a lipid stock mixture comprises about 15% lipids on a
mass/volume basis. In another embodiment, a lipid stock mixture
comprises about 15% lipids on a mass/mass basis. In another
embodiment, a lipid stock mixture comprises about 15% lipids on a
volume/volume basis. In another embodiment, a lipid stock solution
comprises about 15% lipids on a mass/volume basis. In another
embodiment, a lipid stock solution comprises about 15% lipids on a
mass/mass basis. In another embodiment, a lipid stock solution
comprises about 15% lipids on a volume/volume basis. In another
embodiment, a lipid stock mixture comprises about 20% lipids on a
mass/volume basis. In another embodiment, a lipid stock mixture
comprises about 20% lipids on a mass/mass basis. In another
embodiment, a lipid stock mixture comprises about 20% lipids on a
volume/volume basis. In another embodiment, a lipid stock solution
comprises about 20% lipids on a mass/volume basis. In another
embodiment, a lipid stock solution comprises about 20% lipids on a
mass/mass basis. In another embodiment, a lipid stock solution
comprises about 20% lipids on a volume/volume basis. In another
embodiment, a lipid stock mixture comprises about 25% lipids on a
mass/volume basis. In another embodiment, a lipid stock mixture
comprises about 25% lipids on a mass/mass basis. In another
embodiment, a lipid stock mixture comprises about 25% lipids on a
volume/volume basis. In another embodiment, a lipid stock solution
comprises about 25% lipids on a mass/volume basis. In another
embodiment, a lipid stock solution comprises about 25% lipids on a
mass/mass basis. In another embodiment, a lipid stock solution
comprises about 25% lipids on a volume/volume basis. In another
embodiment, a lipid stock mixture comprises about 30% lipids on a
mass/volume basis. In another embodiment, a lipid stock mixture
comprises about 30% lipids on a mass/mass basis. In another
embodiment, a lipid stock mixture comprises about 30% lipids on a
volume/volume basis. In another embodiment, a lipid stock solution
comprises about 30% lipids on a mass/volume basis. In another
embodiment, a lipid stock solution comprises about 30% lipids on a
mass/mass basis. In another embodiment, a lipid stock solution
comprises about 30% lipids on a volume/volume basis. In another
embodiment, a lipid stock mixture comprises about 35% lipids on a
mass/volume basis. In another embodiment, a lipid stock mixture
comprises about 35% lipids on a mass/mass basis. In another
embodiment, a lipid stock mixture comprises about 35% lipids on a
volume/volume basis. In another embodiment, a lipid stock solution
comprises about 35% lipids on a mass/volume basis. In another
embodiment, a lipid stock solution comprises about 35% lipids on a
mass/mass basis. In another embodiment, a lipid stock solution
comprises about 35% lipids on a volume/volume basis. In another
embodiment, a lipid stock mixture comprises about 40% lipids on a
mass/volume basis. In another embodiment, a lipid stock mixture
comprises about 40% lipids on a mass/mass basis. In another
embodiment, a lipid stock mixture comprises about 40% lipids on a
volume/volume basis. In another embodiment, a lipid stock solution
comprises about 40% lipids on a mass/volume basis. In another
embodiment, a lipid stock solution comprises about 40% lipids on a
mass/mass basis. In another embodiment, a lipid stock solution
comprises about 40% lipids on a volume/volume basis. In another
embodiment, a lipid stock mixture comprises about 45% lipids on a
mass/volume basis. In another embodiment, a lipid stock mixture
comprises about 45% lipids on a mass/mass basis. In another
embodiment, a lipid stock mixture comprises about 45% lipids on a
volume/volume basis. In another embodiment, a lipid stock solution
comprises about 45% lipids on a mass/volume basis. In another
embodiment, a lipid stock solution comprises about 45% lipids on a
mass/mass basis. In another embodiment, a lipid stock solution
comprises about 45% lipids on a volume/volume basis. In another
embodiment, a lipid stock mixture comprises about 50% lipids on a
mass/volume basis. In another embodiment, a lipid stock mixture
comprises about 50% lipids on a mass/mass basis. In another
embodiment, a lipid stock mixture comprises about 50% lipids on a
volume/volume basis. In another embodiment, a lipid stock solution
comprises about 50% lipids on a mass/volume basis. In another
embodiment, a lipid stock solution comprises about 50% lipids on a
mass/mass basis. In another embodiment, a lipid stock solution
comprises about 50% lipids on a volume/volume basis.
[0108] In one embodiment, an IDPN composition is lipid-free. In
another embodiment, an IDPN composition is essentially
lipid-free.
[0109] In one embodiment, an IDPN composition is packaged in a
sterile container. In another embodiment, a sterile container is
effective for administration to a subject. In another embodiment, a
sterile container is a bag. In another embodiment, a sterile
container is effective for parenteral administration of an IDPN
composition to a subject. In another embodiment, a bag holds
between about 100 and about 2 liters of an IDPN composition. In
another embodiment, a bag holds between about 300 mL to about 1
liter of an IDPN composition. In another embodiment, a bag holds
between about 419 mL and about 809 mL of an IDPN composition. In
another embodiment, a bag holds between about 350 mL and about 635
mL of an IDPN composition. In another embodiment, a bag holds less
than about 2 liters of an IDPN composition. In another embodiment,
a bag holds less than about 1 liter of an IDPN composition. In
another embodiment, a bag holds more than about 10 mL of an IDPN
composition. In another embodiment, a bag holds more than about 100
mL of an IDPN composition. In another embodiment, a bag holds more
than 1 liter of an IDPN composition.
[0110] In one embodiment, a sterile container holds one dose of an
IDPN composition. In another embodiment, a sterile container is
effective for administration of one dose to a subject.
[0111] In one embodiment, a dose has a volume between about 100 mL
and about 2 liters. In another embodiment, a dose has a volume
between about 350 mL and about 635 mL. In another embodiment, a
dose has a volume of about 300, about 342, about 350, about 383,
about 400, about 419, about 427, about 450, about 483, about 500,
about 540, about 550, about 600, about 613, about 635, about 700 or
about 809 mL. In another embodiment, a dose has a volume less than
about 2 liters. In another embodiment, a dose has a volume less
than about 1 liter. In another embodiment, a dose has a volume more
than about 10 mL. In another embodiment, a dose has a volume more
than about 100 mL. In another embodiment, a dose has a volume more
than 1 liter.
[0112] In one embodiment, a dose comprises between about 10 and
about 50 g of dextrose. In another embodiment, a dose comprises
between about 20 and about 45 g of dextrose. In another embodiment,
a dose comprises more than about 10 g of dextrose. In another
embodiment, a dose comprises less than about 50 g of dextrose. In
another embodiment, a dose comprises about 20, about 23, about 26,
about 30, about 35 or about 41 g of dextrose.
[0113] In one embodiment, the amount of dextrose in a dose is
dependent upon the body mass of a subject receiving the dose. In
another embodiment, the amount of dextrose in a dose is dependent
on the duration of hemodialysis. In another embodiment, the amount
of dextrose in a dose is dependent upon the body mass of a subject
receiving the dose and the duration of hemodialysis. In another
embodiment, a dose comprises less than about 1 g of dextrose per kg
of body mass of the subject. In another embodiment, a dose
comprises a mass of dextrose from about 50% to about 60% the body
mass of a subject on a (g/kg) basis. Non-limiting examples follow.
In one non-limiting example, a subject with a body mass between
about 34 and about 39 kg receives a dose comprising about 20 g of
dextrose. In one non-limiting example, a subject with a body mass
between about 40 and about 44 kg receives a dose comprising about
23 g of dextrose. In one non-limiting example, a subject with a
body mass between about 45 and about 51 kg receives a dose
comprising about 26 g of dextrose. In one non-limiting example, a
subject with a body mass between about 52 and about 59 kg receives
a dose comprising about 30 g of dextrose. In one non-limiting
example, a subject with a body mass between about 60 and about 69
kg receives a dose comprising about 35 g of dextrose. In one
non-limiting example, a subject with a body mass of about 70 kg, or
greater, receives a dose comprising about 41 g of dextrose, or
greater. In one embodiment the duration of hemodialysis is between
2-4.5 hrs. In one embodiment, the duration of hemodialysis is
between 2.75-4 hrs.
[0114] In one embodiment, an IDPN composition comprises between
about 0.10 and about 1.0 g/mL of amino acids. In another
embodiment, an IDPN composition comprises between about 0.10 and
about 0.50 g/mL of amino acids. In another embodiment, an IDPN
composition comprises between about 0.10 and about 0.20 g/mL of
amino acids. In another embodiment, an IDPN composition comprises
between about 0.12 and about 0.18 g/ml of amino acids. In another
embodiment, an IDPN comprises between about 0.15 and about 0.17
g/mL of amino acids. In another embodiment, an IDPN composition
comprises about 0.10, about 0.11, about 0.12, about 0.13, about
0.14, about 0.15, about 0.16, about 0.17, about 0.18, about 0.19 or
about 0.20 g/mL of amino acids. In another embodiment, an IDPN
composition comprises more than about 0.10 g/mL of amino acids. In
another embodiment, an IDPN composition comprises less than about
1.0 g/mL. In another embodiment, an IDPN composition comprises less
than about 0.50 g/mL. In another embodiment, an IDPN composition
comprises less than about 0.20 g/mL. In another embodiment, an IDPN
composition comprises about 0.150, about 0.151, about 0.152, about
0.153, about 0.154, about 0.155, about 0.156, about 0.157, about
0.158, about 0.159, about 0.160, about 0.161, about 0.162, about
0.163, about 0.164, about 0.165, about 0.166, about 0.167, about
0.168, about 0.169 or about 0.170 g/mL of amino acids.
[0115] In one embodiment, a dose comprises a least about 1 g of
amino acids. In another embodiment, a dose comprises less than
about 200 g of amino acids. In another embodiment, a dose comprises
between about 10 and about 200 g of amino acids. In another
embodiment, a dose comprises between about 20 and about 150 g of
amino acids. In another embodiment, a dose comprises between about
30 and about 120 g of amino acids. In another embodiment, a dose
comprises between about 50 and about 110 g of amino acids. In
another embodiment, a dose comprises about 1, about 1.5, about 2,
about 2.5, about 3, about 3.5, about 4, about 4.5, about 5, about
5.5, about 6, about 6.5, about 7, about 7.5, about 8, about 8.5,
about 9, about 9.5, about 10, about 10.5, about 11, about 11.5,
about 12, about 12.5, about 13, about 13.5, about 14, about 14.5,
about 15, about 15.5, about 16, about 16.5, about 17, about 17.5,
about 18, about 18.5, about 19, about 19.5, about 20, about 20.5,
about 21, about 21.5, about 22, about 22.5, about 23, about 23.5,
about 24, about 24.5, about 25, about 25.5, about 26, about 26.5,
about 27, about 27.5, about 28, about 28.5, about 29, about 29.5,
about 30, about 30.5, about 31, about 31.5, about 32, about 32.5,
about 33, about 33.5, about 34, about 34.5, about 35, about 35.5,
about 36, about 36.5, about 37, about 37.5, about 38, about 38.5,
about 39, about 39.5, about 40, about 40.5, about 41, about 41.5,
about 42, about 42.5, about 43, about 43.5, about 44, about 44.5,
about 45, about 45.5, about 46, about 46.5, about 47, about 47.5,
about 48, about 48.5, about 49, about 49.5, about 50, about 50.5,
about 51, about 51.5, about 52, about 52.5, about 53, about 53.5,
about 54, about 54.5, about 55, about 55.5, about 56, about 56.5,
about 57, about 57.5, about 58, about 58.5, about 59, about 59.5,
about 60, about 60.5, about 61, about 61.5, about 62, about 62.5,
about 63, about 63.5, about 64, about 64.5, about 65, about 65.5,
about 66, about 66.5, about 67, about 67.5, about 68, about 68.5,
about 69, about 69.5, about 70, about 70.5, about 71, about 71.5,
about 72, about 72.5, about 73, about 73.5, about 74, about 74.5,
about 75, about 75.5, about 76, about 76.5, about 77, about 77.5,
about 78, about 78.5, about 79, about 79.5, about 80, about 80.5,
about 81, about 81.5, about 82, about 82.5, about 83, about 83.5,
about 84, about 84.5, about 85, about 85.5, about 86, about 86.5,
about 87, about 87.5, about 88, about 88.5, about 89, about 89.5,
about 90, about 90.5, about 91, about 91.5, about 92, about 92.5,
about 93, about 93.5, about 94, about 94.5, about 95, about 95.5,
about 96, about 96.5, about 97, about 97.5, about 98, about 98.5,
about 99, about 99.5, about 100, about 100.5, about 101, about
101.5, about 102, about 102.5, about 103, about 103.5, about 104,
about 104.5, about 105, about 105.5, about 106, about 106.5, about
107, about 107.5, about 108, about 108.5, about 109, about 109.5,
about 110, about 110.5, about 111, about 111.5, about 112, about
112.5, about 113, about 113.5, about 114, about 114.5, about 115,
about 115.5, about 116, about 116.5, about 117, about 117.5, about
118, about 118.5, about 119, about 119.5, about 120, about 120.5,
about 121, about 121.5, about 122, about 122.5, about 123, about
123.5, about 124, about 124.5, about 125, about 125.5, about 126,
about 126.5, about 127, about 127.5, about 128, about 128.5, about
129, about 129.5, about 130, about 130.5, about 131, about 131.5,
about 132, about 132.5, about 133, about 133.5, about 134, about
134.5, about 135, about 135.5, about 136, about 136.5, about 137,
about 137.5, about 138, about 138.5, about 139, about 139.5, about
140, about 140.5, about 141, about 141.5, about 142, about 142.5,
about 143, about 143.5, about 144, about 144.5, about 145, about
145.5, about 146, about 146.5, about 147, about 147.5, about 148,
about 148.5, about 149, about 149.5, about 150, about 150.5, about
151, about 151.5, about 152, about 152.5, about 153, about 153.5,
about 154, about 154.5, about 155, about 155.5, about 156, about
156.5, about 157, about 157.5, about 158, about 158.5, about 159,
about 159.5, about 160, about 160.5, about 161, about 161.5, about
162, about 162.5, about 163, about 163.5, about 164, about 164.5,
about 165, about 165.5, about 166, about 166.5, about 167, about
167.5, about 168, about 168.5, about 169, about 169.5, about 170,
about 170.5, about 171, about 171.5, about 172, about 172.5, about
173, about 173.5, about 174, about 174.5, about 175, about 175.5,
about 176, about 176.5, about 177, about 177.5, about 178, about
178.5, about 179, about 179.5, about 180, about 180.5, about 181,
about 181.5, about 182, about 182.5, about 183, about 183.5, about
184, about 184.5, about 185, about 185.5, about 186, about 186.5,
about 187, about 187.5, about 188, about 188.5, about 189, about
189.5, about 190, about 190.5, about 191, about 191.5, about 192,
about 192.5, about 193, about 193.5, about 194, about 194.5, about
195, about 195.5, about 196, about 196.5, about 197, about 197.5,
about 198, about 198.5, about 199, about 199.5, or about 200 g of
amino acids.
[0116] In one embodiment, the amount of amino acids in a dose is
dependent upon the body mass of a subject receiving the dose. In
another embodiment, the amount of amino acids in a dose is
dependent on the duration of hemodialysis. In another embodiment,
the amount of amino acids in a dose is dependent upon the body mass
of a subject receiving the dose and the duration of hemodialysis.
In another embodiment, a dose comprises less than about 2 g of
amino acids per kg of body mass of the subject. In another
embodiment, a dose comprises a mass of amino acids from about 120%
to about 160% the body mass of a subject on a (g/kg) basis.
Non-limiting examples follow. In one non-limiting example, a
subject with a body mass between about 34 and about 39 kg receives
a dose comprising about 51 g of amino acids. In one non-limiting
example, a subject with a body mass between about 40 and about 44
kg receives a dose comprising about 60 g of amino acids. In one
non-limiting example, a subject with a body mass between about 45
and about 51 kg receives a dose comprising about 68 g of amino
acids. In one non-limiting example, a subject with a body mass
between about 52 and about 59 kg receives a dose comprising about
78 g of amino acids. In one non-limiting example, a subject with a
body mass between about 60 and about 69 kg receives a dose
comprising about 90 g of amino acids. In one non-limiting example,
a subject with a body mass of about 70 kg, or greater, receives a
dose comprising about 105 g of amino acids, or greater. In one
embodiment the duration of hemodialysis is between 2-4.5 hrs. In
one embodiment the duration of hemodialysis is between 2.75-4
hrs.
[0117] In one embodiment, an IDPN composition comprises one or more
lipids. In another embodiment, a lipid is provided in the form of
an emulsion. In another embodiment, a lipid is provided in the form
of an emulsion of purified vegetable oil from soybean. In another
embodiment, an emulsion of purified vegetable oil from soybean is
Intralipid.RTM. (Kabi Vitrum). In another embodiment, an emulsion
of purified vegetable oil from soybean comprises Travamulsion.RTM.
(Travenol). In another embodiment, an emulsion of purified
vegetable oil from soybean comprises egg phospholipids and soybean
oil. In another embodiment, an emulsion of purified vegetable oil
from soybean comprises soybean oil, egg yolk phospholipids,
glycerin, water, and sodium hydroxide. In another embodiment, an
emulsion of purified vegetable oil from soybean comprises
phytosterols. In another embodiment, a lipid is provided in the
form of an emulsion of purified safflower oil. In another
embodiment, an emulsion of purified safflower oil is Liposyn.RTM.
(Abbott). In another embodiment, an emulsion of purified safflower
oil comprises safflower oil, soybean oil, egg phosphatides,
glycerin, water, and sodium hydroxide. In another embodiment, a
lipid is provided in the form of an emulsion of purified fish oil.
In another embodiment, an emulsion of purified fish oil is
Omegaven.RTM. (Fresenius AG). In another embodiment, a lipid is
provided in the form of an emulsion of purified olive oil. In
another embodiment, a lipid is provided in the form of an emulsion
of medium-chain triglyceride oil. In another embodiment, a lipid is
provided in the form of an emulsion of two or more of soybean oil,
safflower oil, fish oil, olive oil and medium-chain triglyceride
oil. In another embodiment, the lipid is 50% soybean oil and 50%
safflower oil. In another embodiment, the lipid is 50% soybean oil
and 50% medium-chain triglyceride oil. In another embodiment, the
lipid is 40% soybean oil, 50% medium-chain triglyceride oil, and
10% fish oil. In another embodiment, the lipid is 25% soybean oil
and 75% medium-chain triglyceride. In another embodiment, the lipid
is 20% soybean oil and 80% olive oil. In another embodiment, a
lipid comprises a triglyceride comprising three fatty acid
residues. In another embodiment, a lipid comprises a triglyceride
comprising saturated and/or unsaturated fatty acid residues. In
another embodiment, a fatty acid residue is derived from linoleic
acid, oleic acid, palmitic acid, or stearic acid. In another
embodiment, a fatty acid residue is derived from eicosapentaenoic
acid, arachidonic acid or docosahexaeneoic acid. In another
embodiment, a lipid comprises a phospholipid. In another
embodiment, an IDPN composition comprises about 5 to about 30%
lipids by volume. In another embodiment, a composition comprises
about 10 to about 20% lipids by volume. In another embodiment, an
IDPN composition comprises lipids and propofol. In another
embodiment, an IDPN composition comprises lipids, propofol, and a
cyclodrtrin, a cyclodextrin analogue, or a
pharmaceutically-acceptable salt of cyclodextrin. In another
embodiment, a composition does not comprise a lipid. In another
embodiment, a composition that does not comprise a lipid is
administered to a subject comprising hyperlipemia, acute
pancreatitis, lipid nephrosis or allergic reactions to eggs.
[0118] In one embodiment, a dose comprises between about 5 and
about 50 g of lipids. In another embodiment, a dose comprises
between about 5 and about 30 g of lipids. In another embodiment, a
dose comprises between about 10 and about 25 g of lipids. In
another embodiment, a dose comprises more than about 5 g of lipids.
In another embodiment, a dose comprises less than about 50 g of
lipids. In another embodiment, a dose comprises about 5 g, about 6
g, about 7 g, about 8 g, about 9 g, about 10 g, about 11 g, about
12 g, about 13 g, about 14 g, about 15 g, about 16 g, about 17 g,
about 18 g, about 19 g, about 20 g, about 21 g, about 22 g, about
23 g, about 24 g, about 25 g, about 26 g, about 27 g, about 28 g,
about 29 g, about 30 g, about 31 g, about 32 g, about 33 g, about
34 g, about 35 g, about 36 g, about 37 g, about 38 g, about 39 g,
about 40 g, about 41 g, about 42 g, about 43 g, about 44 g, about
45 g, about 46 g, about 47 g, about 48 g, about 49 g, or about 50 g
of lipids.
[0119] In one embodiment, the amount of lipids in a dose is
dependent upon the body mass of a subject receiving the dose. In
another embodiment, the amount of lipids in a dose is dependent on
the duration of hemodialysis. In another embodiment, the amount of
lipids in a dose is dependent upon the body mass of a subject
receiving the dose and the duration of hemodialysis. In another
embodiment, a dose comprises less than about 0.4 g of lipids per kg
of body mass of the subject. In another embodiment, a dose
comprises a mass of lipids from about 10% to about 40% the body
mass of a subject on a (g/kg) basis. In another embodiment, a dose
comprises a mass of lipids from about 20% to about 30% the body
mass of a subject on a (g/kg) basis. Non-limiting examples follow.
In one non-limiting example, a subject with a body mass between
about 34 and about 39 kg receives a dose comprising about 8.6 g of
lipids. In one non-limiting example, a subject with a body mass
between about 40 and about 44 kg receives a dose comprising about
10.2 g of lipids. In one non-limiting example, a subject with a
body mass between about 45 and about 51 kg receives a dose
comprising about 11.2 g of lipids. In one non-limiting example, a
subject with a body mass between about 52 and about 59 kg receives
a dose comprising about 13.2 g of lipids. In one non-limiting
example, a subject with a body mass between about 60 and about 69
kg receives a dose comprising about 15.2 g of lipids. In one
non-limiting example, a subject with a body mass of about 70 kg, or
greater, receives a dose comprising about 17.8 g of lipids, or
greater. In one embodiment, the duration of hemodialysis is between
2-4.5 hrs. In one embodiment, the duration of hemodialysis is
between 2.75-4 hrs.
[0120] In one embodiment, the presence of a lipid improves the
ability of an IDPN composition to increase albumin levels in a
subject. In another embodiment, the presence of a lipid does not
improve the ability of an IDPN composition to increase albumin
levels in a subject. In another embodiment, the presence of a lipid
increases the nutritional value of an IDPN composition. In another
embodiment, the presence of a lipid increases the caloric content
of an IDPN composition. In another embodiment, an IDPN composition
comprising a lipid has higher nutritional value than an IDPN
composition that does not comprise a lipid. In another embodiment,
an IDPN composition comprising a lipid has higher caloric content
than an IDPN composition that does not comprise a lipid. In one
embodiment, a subject being administered an IDPN composition with a
low caloric content does not catabolize the amino acids of the IDPN
composition. In one embodiment, a subject being administered an
IDPN composition with a low caloric content catabolizes the amino
acids of the IDPN composition. In one embodiment, a subject being
administered an IDPN composition with a low caloric content
catabolizes the amino acids of the IDPN composition, thereby
diminishing the increase in albumin levels. In one embodiment, a
subject being administered an IDPN composition that does not
comprise lipids does not catabolize the amino acids of the IDPN
composition. In one embodiment, a subject being administered an
IDPN composition that does not comprise lipids catabolizes the
amino acids of the IDPN composition. In one embodiment, a subject
being administered an IDPN composition that does not comprise
lipids catabolizes the amino acids of the IDPN composition, thereby
diminishing the increase in albumin levels. In another embodiment,
a subject being administered an IDPN composition with a high
caloric content does not catabolize the amino acids of the IDPN
composition. In another embodiment, a subject being administered an
IDPN composition comprising a lipid does not catabolize the amino
acids of the IDPN composition. In another embodiment, a subject
being administered an IDPN composition with a high caloric content
does not catabolize the amino acids of the IDPN composition,
thereby enabling an increase in albumin levels. In another
embodiment, a subject being administered an IDPN composition
comprising a lipid does not catabolize the amino acids of the IDPN
composition, thereby enabling an increase in albumin levels.
[0121] In one embodiment, an IDPN composition comprises one or more
micronutrients. In another embodiment, an IDPN composition is
co-administered with one or more micronutrients. In another
embodiment, a micronutrient is a vitamin, a trace element, and/or a
mineral. In another embodiment, a vitamin is a water soluble
vitamin. In another embodiment, the vitamin is vitamin C, folic
acid, vitamin B.sub.1, or vitamin B.sub.6. In another embodiment, a
vitamin comprises a multivitamin lacking vitamin K. In another
embodiment, a trace element comprises one or more of zinc,
selenium, copper, chromium, magnesium, and manganese. In another
embodiment, a mineral comprises a mineral salt. In another
embodiment, a mineral salt comprises sodium phosphate, sodium
chloride, sodium iodide, sodium acetate, potassium chloride,
potassium iodide, potassium acetate, potassium metabisulfite,
calcium acetate, magnesium acetate, or magnesium sulfate. In
another embodiment, a mineral salt comprises a lithium, sodium,
potassium, calcium, magnesium, aluminum, zinc, cesium, scandium,
titanium, zirconium, hafnium, vanadium, chromium, molybdenum,
manganese, iron, ruthenium, osmium, cobalt, rhenium, iridium,
nickel, palladium, platinum, copper, silver, gold, cadmium,
mercury, indium, tin, lead, bismuth, cerium, samarium, or strontium
salt, or a combination of any of the forgoing. In another
embodiment, a mineral salt comprises a fluoride, chloride, bromide,
iodide, nitrate, nitrite, phosphate, sulfate, sulfite, bisulfite,
thiosulfate, carbonate, bicarbonate, chlorate, perchlorate,
chlorite, or hypochlorite salt, or a combination of any of the
forgoing.
[0122] In one embodiment, an IDPN composition comprises one or more
pharmaceutical agents. One non-limiting example of a pharmaceutical
agent appropriate for inclusion in an IDPN composition is insulin.
In another embodiment, insulin is added to an IDPN composition
prior to administration to the subject. In another embodiment, the
addition of insulin to an IDPN composition in a container takes
place immediately prior to administration to prevent absorption of
the insulin by a container material. In another embodiment, insulin
is co-administered with an IDPN composition. In another embodiment,
the insulin is subcutaneously injected during treatment with an
IDPN composition. In another embodiment, about 5 to about 20 units
of insulin is added with one dose of an IDPN composition.
[0123] In one embodiment, an IDPN composition is co-administered
with one or more pharmaceutical agents. In another embodiment,
co-administration of a pharmaceutical agent takes place prior to
administration of an IDPN composition. In another embodiment,
co-administration of a pharmaceutical agent takes place during
administration of an IDPN composition. In another embodiment,
co-administration of a pharmaceutical agent takes place after
administration of an IDPN composition. Non-limiting examples of
pharmaceutical agents that are co-administered with an IDPN
composition include: an erythropoietin agent, for example,
Procrit.RTM., Epogen.RTM., ARANESP.RTM. or epoietin alpha; and iron
agent, for example, InFeD.RTM., Ferrlecit.RTM. and Venofer.RTM.; a
phosphorous binder, for example, PhosLo.RTM. (calcium acetate),
Tums.RTM. (calcium carbonate), Renagel.RTM. (sevelamer), and
Fosrenol.RTM. (lanthanum carbonate); an active vitamin D agent, for
example, Rocaltrol.RTM. (calcitriol) and Hectorol.RTM.
(doxercalciferol); Zemplar.RTM. (paricalcitol), Calcijex.RTM.
(calcitrol), and Sensipar.RTM. (cinacalcet); vitamin complex
agents, for example, Nephro-Vite.RTM., Nephrocaps.RTM. and
Nephroplex.RTM.; an antihistamine, for example, Benadryl.RTM.
(diphenhydramine), Atarax.RTM. or Vistaril.RTM. (hydroxyzine), and
Zyrtec.RTM. (loratadine); and a statin, for example, Lipitor.RTM.
(Atorvastatin), Zocor.RTM. (Simvastatin), and Pravachol.RTM.
(Pravastatin).
[0124] In one embodiment, an IDPN composition is administered with
a fill. In another embodiment, a fill comprises water. In another
embodiment, a fill comprises sterile water. In another embodiment,
a fill consists of sterile water. In another embodiment, a fill
comprises saline. In another embodiment, a fill consists of saline.
In another embodiment, a fill comprises physiological saline. In
another embodiment, a fill consists of physiological saline. In
another embodiment, a fill comprises an IDPN composition. In
another embodiment, a fill consists of an IDPN composition. In
another embodiment, a fill comprises an IDPN composition that is
administered with the fill. In another embodiment, a fill consists
of an IDPN composition that is administered with the fill. In
another embodiment, a fill has a volume of greater than about 1 mL.
In another embodiment, a fill has a volume of greater than about 10
mL. In another embodiment, a fill has a volume of less than about
200 mL. In another embodiment, a fill has a volume of less than
about 150 mL. In another embodiment, a fill has a volume of from
about 1 mL to about 200 mL. In another embodiment, a fill has a
volume of from about 10 mL to about 100 mL. In another embodiment,
a fill has a volume of from about 25 mL to about 75 mL. In another
embodiment, a fill has a volume of from about 40 mL to about 60 mL.
In another embodiment, a fill has a volume greater than about 25
ml. In another embodiment, a fill has a volume less than about 75
mL. In another embodiment, a fill has a volume of about 5 mL, about
10 mL, about 15 mL, about 20 mL, about 25 mL, about 30 mL, about 35
mL, about 40 mL, about 45 mL, about 50 mL, about 55 mL, about 60
mL, about 65 mL, about 70 mL, about 75 mL, about 80 mL, about 85
mL, about 90 mL, about 95 mL, about 100 mL, about 105 mL, about 110
mL, about 115, mL, about 120 mL, about 125 mL, about 130 mL, about
135 mL, about 140 mL, about 145 mL, or about 150 mL. In another
embodiment, a fill has a volume of about 50 mL.
[0125] In one embodiment, an IDPN composition is administered
simultaneously with a fill. In another embodiment, an IDPN
composition is administered after a fill is administered. In
another embodiment, a fill is used to prime a dialysis tubing. In
another embodiment, a fill is administered to a subject. In another
embodiment, a fill is not administered to a subject. In another
embodiment, a fill is premixed with an IDPN composition.
[0126] In one embodiment, an IDPN composition comprises an amount
of a stock carbohydrate solution and an amount of an amino acid
stock mixture. In another embodiment, an IDPN composition comprises
an amount of a stock carbohydrate solution and an amount of an
amino acid stock solution. In another embodiment, an IDPN
composition comprises a volume of a stock carbohydrate solution and
a volume of an amino acid stock mixture. In another embodiment, an
IDPN composition comprises a volume of a stock carbohydrate
solution and a volume of an amino acid stock solution. In another
embodiment, an IDPN composition further comprises a fill. In
another embodiment, an IDPN composition further comprises an amount
of a fill. In another embodiment, an IDPN composition further
comprises a volume of a fill.
[0127] In one embodiment, an IDPN composition comprises an amount
of a stock carbohydrate solution, an amount of an amino acid stock
mixture, and an amount of a fill. In another embodiment, an IDPN
composition comprises an amount of a stock carbohydrate solution,
an amount of an amino acid stock solution, and an amount of a fill.
In another embodiment, an IDPN composition comprises a volume of a
stock carbohydrate solution, a volume of an amino acid stock
mixture, and a volume of a fill. In another embodiment, an IDPN
composition comprises a volume of a stock carbohydrate solution, a
volume of an amino acid stock solution, and a volume of a fill.
IDPN Compositions Effective to Modulate Albumin Levels in a
Subject
[0128] In one embodiment, an IDPN composition is effective to
modulate albumin levels of a subject. In another embodiment, an
IDPN composition is effective to increase albumin levels of a
subject. In another embodiment, the modulation in albumin levels is
relative to the amount of an IDPN composition administered to a
subject. In another embodiment, a modulation in albumin levels is
independent of the amount of an IDPN composition administered to a
subject.
[0129] In one embodiment, a modulation in albumin levels is greater
than about 0.01 g/dL. In another embodiment, a modulation in
albumin levels is greater than about 0.05 g/dL. In another
embodiment, a modulation in albumin levels is greater than about
0.1 g/dL. In another embodiment, a modulation in albumin levels is
less than about 1.0 g/dL. In another embodiment, a modulation in
albumin levels is less than about 0.8 g/dL. In another embodiment,
a modulation in albumin levels is less than about 0.6 g/dL. In
another embodiment, a modulation in albumin levels is from about
0.01 g/dL to about 1.0 g/dL. In another embodiment, a modulation in
albumin levels is from about 0.05 g/dL to about 0.8 g/dL. In
another embodiment, a modulation in albumin levels is from about
0.1 g/dL to about 0.6 g/dL. In another embodiment, a modulation in
albumin levels is from about 0.2 g/dL to about 0.4 g/dL.
[0130] In one embodiment, a increase in albumin levels is greater
than about 0.01 g/dL. In another embodiment, a increase in albumin
levels is greater than about 0.05 g/dL. In another embodiment, a
increase in albumin levels is greater than about 0.1 g/dL. In
another embodiment, a increase in albumin levels is less than about
1.0 g/dL. In another embodiment, a increase in albumin levels is
less than about 0.8 g/dL. In another embodiment, a increase in
albumin levels is less than about 0.6 g/dL. In another embodiment,
a increase in albumin levels is from about 0.01 g/dL to about 1.0
g/dL. In another embodiment, a increase in albumin levels is from
about 0.05 g/dL to about 0.8 g/dL. In another embodiment, a
increase in albumin levels is from about 0.1 g/dL to about 0.6
g/dL. In another embodiment, a increase in albumin levels is from
about 0.2 g/dL to about 0.4 g/dL.
[0131] In one embodiment, a modulation in albumin levels is greater
than about 1%. In another embodiment, a modulation in albumin
levels is greater than about 5%. In another embodiment, a
modulation in albumin levels is greater than about 10%. In another
embodiment, a modulation in albumin levels is greater than about
25%. In another embodiment, a modulation in albumin levels is
greater than about 50%. In another embodiment, a modulation in
albumin levels is greater than about 100%. In another embodiment, a
modulation in albumin levels is less than about 100%. In another
embodiment, a modulation in albumin levels is less than about 50%.
In another embodiment, a modulation in albumin levels is less than
about 25%. In another embodiment, a modulation in albumin levels is
less than about 10%. In another embodiment, a modulation in albumin
levels is less than about 5%. In another embodiment, a modulation
in albumin levels is less than about 1%. In another embodiment, a
modulation in albumin levels is from about 1% to about 100%. In
another embodiment, a modulation in albumin levels is from about 5%
to about 50%. In another embodiment, a modulation in albumin levels
is from about 10% to about 50%. In another embodiment, a modulation
in albumin levels is from about 25% to about 50%. In another
embodiment, a modulation in albumin levels is about 0.1%, about
0.2%, about 0.3%, about 0.4%, about 0.5%, about 0.6%, about 0.7%,
about 0.8%, about 0.9%, about 1%, about 1.1%, about 1.2%, about
1.3%, about 1.4%, about 1.5%, about 1.6%, about 1.7%, about 1.8%,
about 1.9%, about 2%, about 2.1%, about 2.2%, about 2.3%, about
2.4%, about 2.5%, about 2.6%, about 2.7%, about 2.8%, about 2.9%,
about 3%, about 3.1%, about 3.2%, about 3.3%, about 3.4%, about
3.5%, about 3.6%, about 3.7%, about 3.8%, about 3.9%, about 4%,
about 4.1%, about 4.2%, about 4.3%, about 4.4%, about 4.5%, about
4.6%, about 4.7%, about 4.8%, about 4.9%, about 5%, about 5.5%,
about 6%, about 6.5%, about 7%, about 7.5%, about 8%, about 8.5%,
about 9%, about 9.5%, about 10%, about 11%, about 12%, about 13%,
about 14%, about 15%, about 16%, about 17%, about 18%, about 19%,
about 20%, about 21%, about 22%, about 23%, about 24%, about 25%,
about 26%, about 27%, about 28%, about 29%, about 30%, about 31%,
about 32%, about 33%, about 34%, about 35%, about 36%, about 37%,
about 38%, about 39%, about 40%, about 41%, about 42%, about 43%,
about 44%, about 45%, about 46%, about 47%, about 48%, about 49%,
about 50%, about 51%, about 52%, about 53%, about 54%, about 55%,
about 56%, about 57%, about 58%, about 59%, about 60%, about 61%,
about 62%, about 63%, about 64%, about 65%, about 66%, about 67%,
about 68%, about 69%, about 70%, about 71%, about 72%, about 73%,
about 74%, about 75%, about 76%, about 77%, about 78%, about 79%,
about 80%, about 81%, about 82%, about 83%, about 84%, about 85%,
about 86%, about 87%, about 88%, about 89%, about 90%, about 91%,
about 92%, about 93%, about 94%, about 95%, about 96%, about 97%,
about 98%, about 99%, or about 100%.
[0132] In one embodiment, an increase in albumin levels is greater
than about 1%. In another embodiment, an increase in albumin levels
is greater than about 5%. In another embodiment, an increase in
albumin levels is greater than about 10%. In another embodiment, an
increase in albumin levels is greater than about 25%. In another
embodiment, an increase in albumin levels is greater than about
50%. In another embodiment, an increase in albumin levels is
greater than about 100%. In another embodiment, an increase in
albumin levels is less than about 100%. In another embodiment, an
increase in albumin levels is less than about 50%. In s one
embodiment, an increase in albumin levels is less than about 25%.
In another embodiment, an increase in albumin levels is less than
about 10%. In another embodiment, an increase in albumin levels is
less than about 5%. In another embodiment, an increase in albumin
levels is less than about 1%. In another embodiment, an increase in
albumin levels is from about 1% to about 100%. In another
embodiment, an increase in albumin levels is from about 5% to about
50%. In another embodiment, an increase in albumin levels is from
about 10% to about 50%. In another embodiment, an increase in
albumin levels is from about 25% to about 50%. In another
embodiment, an increase in albumin levels is about 0.1%, about
0.2%, about 0.3%, about 0.4%, about 0.5%, about 0.6%, about 0.7%,
about 0.8%, about 0.9%, about 1%, about 1.1%, about 1.2%, about
1.3%, about 1.4%, about 1.5%, about 1.6%, about 1.7%, about 1.8%,
about 1.9%, about 2%, about 2.1%, about 2.2%, about 2.3%, about
2.4%, about 2.5%, about 2.6%, about 2.7%, about 2.8%, about 2.9%,
about 3%, about 3.1%, about 3.2%, about 3.3%, about 3.4%, about
3.5%, about 3.6%, about 3.7%, about 3.8%, about 3.9%, about 4%,
about 4.1%, about 4.2%, about 4.3%, about 4.4%, about 4.5%, about
4.6%, about 4.7%, about 4.8%, about 4.9%, about 5%, about 5.5%,
about 6%, about 6.5%, about 7%, about 7.5%, about 8%, about 8.5%,
about 9%, about 9.5%, about 10%, about 11%, about 12%, about 13%,
about 14%, about 15%, about 16%, about 17%, about 18%, about 19%,
about 20%, about 21%, about 22%, about 23%, about 24%, about 25%,
about 26%, about 27%, about 28%, about 29%, about 30%, about 31%,
about 32%, about 33%, about 34%, about 35%, about 36%, about 37%,
about 38%, about 39%, about 40%, about 41%, about 42%, about 43%,
about 44%, about 45%, about 46%, about 47%, about 48%, about 49%,
about 50%, about 51%, about 52%, about 53%, about 54%, about 55%,
about 56%, about 57%, about 58%, about 59%, about 60%, about 61%,
about 62%, about 63%, about 64%, about 65%, about 66%, about 67%,
about 68%, about 69%, about 70%, about 71%, about 72%, about 73%,
about 74%, about 75%, about 76%, about 77%, about 78%, about 79%,
about 80%, about 81%, about 82%, about 83%, about 84%, about 85%,
about 86%, about 87%, about 88%, about 89%, about 90%, about 91%,
about 92%, about 93%, about 94%, about 95%, about 96%, about 97%,
about 98%, about 99%, or about 100%.
[0133] In one embodiment, a modulation in albumin levels is
observable within about an hour, within about 4 hours, within about
8 hours, within about 12 hours, within about 24 hours, within about
2 days, within about 3 days, within about 4 days, within about 5
days, within about 6 days, or within about 7 days. In another
embodiment, a modulation in albumin levels is observable within
about a month, within about 2 months, within about 3 months, within
about 4 months, within about 5 months, within about 6 months,
within about 7 months, within about 8 months, within about 9
months, within about 10 months, within about 11 months, or within
about 12 months. In another embodiment, a modulation in albumin
levels is observable within about 6 months. In another embodiment,
a modulation in albumin levels is observable within about a
year.
[0134] In one embodiment, an increase in albumin levels is
observable within about an hour, within about 4 hours, within about
8 hours, within about 12 hours, within about 24 hours, within about
2 days, within about 3 days, within about 4 days, within about 5
days, within about 6 days, or within about 7 days. In another
embodiment, an increase in albumin levels is observable within
about a month, within about 2 months, within about 3 months, within
about 4 months, within about 5 months, within about 6 months,
within about 7 months, within about 8 months, within about 9
months, within about 10 months, within about 11 months, or within
about 12 months. In another embodiment, an increase in albumin
levels is observable within about 6 months. In another embodiment,
an increase in albumin levels is observable within about a
year.
[0135] In one embodiment, therapy continues until a desired
increase in albumin levels is observed in a subject. In another
embodiment, a desired increase in albumin levels is greater than
about 0.05 g/dL. In another embodiment, a desired increase in
albumin levels is greater than about 0.1 g/dL. In another
embodiment, a desired increase in albumin levels is less than about
1.0 g/dL. In another embodiment, a desired increase in albumin
levels is less than about 0.6 g/dL. In another embodiment, a
desired increase in albumin levels is from about 0.05 to about 1.0
g/dL. In another embodiment, a desired increase in albumin levels
is from about 0.1 to about 0.6 g/dL. In another embodiment, a
desired increase in albumin levels is from about 0.2 to about 0.4
g/dL. In another embodiment, a desired increase in albumin levels
is about 0.05, about 0.10, about 0.15, about 0.20, about 0.25,
about 0.30, about 0.35, about 0.40, about 0.45, about 0.50, about
0.55, about 0.60, about 0.65, about 0.70, about 0.75, about 0.80,
about 0.85, about 0.90, about 0.95, or about 1.00 g/dL.
[0136] In one embodiment, therapy continues until a desired albumen
level in a subject is reached. In another embodiment, a desired
albumin level is greater than about 3.5 g/dL. In another
embodiment, a desired albumin level is less than about 4.0 g/dL. In
another embodiment, a desired albumin level is from about 3.5 to
about 4.0 g/dL. In another embodiment, a desired albumin level is
about 3.5, about 3.55, about 3.6, about 3.65, about 3.7, about
3.75, about 3.8, about 3.85, about 3.9, about 3.95, or about 4.0
g/dL. In another embodiment, a desired albumin level is about 3.8
g/dL.
[0137] In one embodiment, an IDPN composition is co-administered
with one or more agents effective to increase albumin levels in a
subject. In another embodiment, an IDPN composition is
co-administered with one or more appetite stimulants. Non-limiting
examples of appetite stimulants include marinol, cyprohepatadine,
megestrol acetate, and pizotifen. In another embodiment, an IDPN
composition is co-administered with megestrol acetate.
IDPN Compositions Effective to Modulate Glucose Levels in a
Subject
[0138] In one embodiment, IDPN compositions with low glucose levels
allow medical personnel to engage in reduced carbohydrate
management for MHD subjects when the subjects receive IDPN. In
another embodiment, an IDPN composition is effective for treating
or preventing malnutrition in a MHD subject with glucose management
difficulties, insulin resistance, type I diabetes, type II
diabetes, and/or pancreatitis. In some embodiments, a subject
receiving an IDPN composition experiences reduced symptoms of
hyperglycemia. In certain embodiments, low glucose IDPN
compositions provided herein warrant less stringent glucose
monitoring. In some embodiments, insulin administration is required
when low glucose IDPN compositions provided herein are administered
to a subject. In other embodiments, no insulin administration is
required when low glucose IDPN compositions provided herein are
administered to a subject. In other embodiments, less insulin
administration is required when low glucose IDPN compositions
provided herein are administered to a subject as compared to the
administration of regular glucose IDPN composition.
[0139] In one embodiment, an IDPN composition is effective to
modulate blood glucose levels of a subject. In another embodiment,
an IDPN composition is effective to decrease blood glucose levels
of a subject. In another embodiment, a low glucose IDPN composition
is effective to decrease blood glucose levels of a subject compared
to a subject being administered regular glucose level IDPN
composition. In another embodiment, the modulation in blood glucose
levels is relative to the amount of an IDPN composition
administered to a subject. In another embodiment, a modulation in
blood glucose levels is independent of the amount of an IDPN
composition administered to a subject. In certain embodiments, no
insulin is administered to a subject being administered an IDPN
composition. In some embodiments, blood glucose levels are measured
pre-infusion, mid-infusion, post-infusion, or any combination
thereof. In another embodiment, the subject has a post-hemodialysis
blood glucose level that is within 1-25% of the subject's
pre-hemodialysis blood glucose level. In another embodiment, the
subject has a post-hemodialysis blood glucose level that is within
1-20% of the subject's pre-hemodialysis blood glucose level. In
another embodiment, the subject has a post-hemodialysis blood
glucose level that is within 1-15% of the subject's
pre-hemodialysis blood glucose level. In another embodiment, the
subject has a post-hemodialysis blood glucose level that is within
1-10% of the subject's pre-hemodialysis blood glucose level. In
another embodiment, the subject has a post-hemodialysis blood
glucose level that is within 1-5% of the subject's pre-hemodialysis
blood glucose level. In another embodiment, the subject has a
post-hemodialysis blood glucose level that is within 10% of their
pre-hemodialysis blood glucose level. In another embodiment, the
subject has a post-hemodialysis blood glucose level that is within
5% of the subject's pre-hemodialysis blood glucose level. In
another embodiment, the subject has a post-hemodialysis blood
glucose level that is within about 1, 2, 3, 4, 5, 6, 7, 8, 9 or 10%
of the subject's pre-hemodialysis blood glucose level. In another
embodiment, the hemodialyis moduylates the blood glucose levels of
the subject. In another embodiment, the subject's blood glucose
levels vary less than 30% during-hemodialysis. In another
embodiment, the subject's blood glucose levels vary less than 30%
pre-, mid-, and post-hemodialysis. In another embodiment, the
subject's blood glucose levels vary less than 25%
during-hemodialysis. In another embodiment, the subject's blood
glucose levels vary less than 25% pre-, mid-, and
post-hemodialysis. In another embodiment, the subject's blood
glucose levels vary less than 20% during-hemodialysis. In another
embodiment, the subject's blood glucose levels vary less than 20%
pre-, mid-, and post-hemodialysis. In another embodiment, the
subject's blood glucose levels vary less than 15%
during-hemodialysis. In another embodiment, the subject's blood
glucose levels vary less than 15% pre-, mid-, and
post-hemodialysis. In another embodiment, the subject's blood
glucose levels vary less than 10% during-hemodialysis In another
embodiment, the subject's blood glucose levels vary less than 10%
pre-, mid-, and post-hemodialysis. In another embodiment, the
subject's blood glucose levels vary less than 5%
during-hemodialysis. In another embodiment, the subject's blood
glucose levels vary less than 5% pre-, mid-, and post-hemodialysis.
In another embodiment, the subject's blood glucose levels vary less
than 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10% during-hemodialysis. In
another embodiment, the subject's blood glucose levels vary less
than 0-10% pre-, mid-, and post-hemodialysis. In another
embodiment, the subject's blood glucose levels decrease during
dialysis. In another embodiment, the subject's post-hemodialysis
blood glucose levels decrease by at least 20% as compared to the
subject's pre-hemodialysis glucose levels. In another embodiment,
the subject's post-hemodialysis blood glucose levels decrease by at
least 15% as compared to the subject's pre-hemodialysis glucose
levels. In another embodiment, the subject's post-hemodialysis
blood glucose levels decrease by at least 10% as compared to the
subject's pre-hemodialysis glucose levels. In another embodiment,
the subject's post-hemodialysis blood glucose levels decrease by at
least 5% as compared to the subject's pre-hemodialysis glucose
levels. In another embodiment, the subject's post-hemodialysis
blood glucose levels decrease by at least 1, 2, 3, 4, 5, 6, 7, 8,
9, or 10% as compared to the subject's pre-hemodialysis glucose
levels. In another embodiment, the subject's post-hemodialysis
blood glucose levels decrease by at least 2% as compared to the
subject's pre-hemodialysis glucose levels. In another embodiment,
the subject's post-hemodialysis blood glucose levels decrease by
0-10% as compared to the subject's pre-hemodialysis glucose levels.
In another embodiment, the subject's post-hemodialysis blood
glucose levels decrease by 0-5% as compared to the subject's
pre-hemodialysis glucose levels.
[0140] In one embodiment, an IDPN composition is effective to
decrease pre-infusion levels of blood glucose by about 5 mg/dL at
post-infusion. In one embodiment, an IDPN composition is effective
to decrease pre-infusion levels of blood glucose by about 10 mg/dL
at post-infusion. In one embodiment, an IDPN composition is
effective to decrease pre-infusion levels of blood glucose by about
15 mg/dL at post-infusion. In one embodiment, an IDPN composition
is effective to decrease pre-infusion levels of blood glucose by
about 20 mg/dL at post-infusion. In one embodiment, an IDPN
composition is effective to decrease pre-infusion levels of blood
glucose by about 25 mg/dL at post-infusion. In one embodiment, an
IDPN composition is effective to decrease pre-infusion levels of
blood glucose by about 30 mg/dL at post-infusion. In one
embodiment, an IDPN composition is effective to decrease
pre-infusion levels of blood glucose by about 35 mg/dL at
post-infusion. In one embodiment, an IDPN composition is effective
to decrease pre-infusion levels of blood glucose by about 40 mg/dL
at post-infusion. In one embodiment, an IDPN composition is
effective to decrease pre-infusion levels of blood glucose by about
45 mg/dL at post-infusion. In one embodiment, an IDPN composition
is effective to decrease pre-infusion levels of blood glucose by
about 50 mg/dL at post-infusion. In another embodiment, an IDPN
composition is effective to decrease pre-infusion levels of blood
glucose by about 5 mg/dL to about 25 mg/dL at post-infusion. In
another embodiment, an IDPN composition is effective to decrease
pre-infusion levels of blood glucose by about 5 mg/dL to about 15
mg/dL at post-infusion. In another embodiment, an IDPN composition
is effective to decrease pre-infusion levels of blood glucose by
about 10 mg/dL to about 35 mg/dL at post-infusion. In another
embodiment, an IDPN composition is effective to decrease
pre-infusion levels of blood glucose by about 15 mg/dL to about 50
mg/dL at post-infusion.
[0141] In one embodiment, an IDPN composition is effective to
decrease pre-infusion levels of blood glucose by about 1% at
post-infusion. In one embodiment, an IDPN composition is effective
to decrease pre-infusion levels of blood glucose by about 2% at
post-infusion. In one embodiment, an IDPN composition is effective
to decrease pre-infusion levels of blood glucose by about 5% at
post-infusion. In one embodiment, an IDPN composition is effective
to decrease pre-infusion levels of blood glucose by about 10% at
post-infusion. In one embodiment, an IDPN composition is effective
to decrease pre-infusion levels of blood glucose by about 15% at
post-infusion. In one embodiment, an IDPN composition is effective
to decrease pre-infusion levels of blood glucose by about 20% at
post-infusion. In one embodiment, an IDPN composition is effective
to decrease pre-infusion levels of blood glucose by about 25% at
post-infusion. In one embodiment, an IDPN composition is effective
to decrease pre-infusion levels of blood glucose by about 30% at
post-infusion. In another embodiment, an IDPN composition is
effective to decrease pre-infusion levels of blood glucose by about
1% to about 5% at post-infusion. In another embodiment, an IDPN
composition is effective to decrease pre-infusion levels of blood
glucose by about 1% to about 10% at post-infusion. In another
embodiment, an IDPN composition is effective to decrease
pre-infusion levels of blood glucose by about 2% to about 15% at
post-infusion. In another embodiment, an IDPN composition is
effective to decrease pre-infusion levels of blood glucose by about
2% to about 30% at post-infusion. In one embodiment, an IDPN
composition is effective to decrease pre-infusion levels of blood
glucose by at least 1% at post-infusion. In one embodiment, an IDPN
composition is effective to decrease pre-infusion levels of blood
glucose by at least 2% at post-infusion. In one embodiment, an IDPN
composition is effective to decrease pre-infusion levels of blood
glucose by at least 5% at post-infusion. In one embodiment, an IDPN
composition is effective to decrease pre-infusion levels of blood
glucose by at least 10% at post-infusion. In one embodiment, an
IDPN composition is effective to decrease pre-infusion levels of
blood glucose by at least 15% at post-infusion. In one embodiment,
an IDPN composition is effective to decrease pre-infusion levels of
blood glucose by at least 20% at post-infusion. In one embodiment,
an IDPN composition is effective to decrease pre-infusion levels of
blood glucose by at least 25% at post-infusion. In one embodiment,
an IDPN composition is effective to decrease pre-infusion levels of
blood glucose by at least 30% at post-infusion.
[0142] In one embodiment, an IDPN composition is effective to
achieve mid-infusion blood glucose levels less than 5 mg/dL higher
than pre-infusion levels. In one embodiment, an IDPN composition is
effective to achieve mid-infusion blood glucose levels less than 10
mg/dL higher than pre-infusion levels. In one embodiment, an IDPN
composition is effective to achieve mid-infusion blood glucose
levels less than 15 mg/dL higher than pre-infusion levels. In one
embodiment, an IDPN composition is effective to achieve
mid-infusion blood glucose levels less than 20 mg/dL higher than
pre-infusion levels. In one embodiment, an IDPN composition is
effective to achieve mid-infusion blood glucose levels less than 25
mg/dL higher than pre-infusion levels. In one embodiment, an IDPN
composition is effective to achieve mid-infusion blood glucose
levels less than 30 mg/dL higher than pre-infusion levels. In
another embodiment, an IDPN composition is effective to achieve
mid-infusion blood glucose levels 5 mg/dL to 25 mg/dL higher than
pre-infusion levels. In another embodiment, an IDPN composition is
effective to achieve mid-infusion blood glucose levels 5 mg/dL to
15 mg/dL higher than pre-infusion levels. In another embodiment, an
IDPN composition is effective to achieve mid-infusion blood glucose
levels 5 mg/dL to 25 mg/dL higher than pre-infusion levels. In
another embodiment, an IDPN composition is effective to achieve
mid-infusion blood glucose levels 10 mg/dL to 35 mg/dL higher than
pre-infusion levels. In another embodiment, an IDPN composition is
effective to achieve mid-infusion blood glucose levels 10 mg/dL to
30 mg/dL higher than pre-infusion levels.
[0143] In one embodiment, an IDPN composition is effective to
achieve mid-infusion blood glucose levels less than 1% higher than
pre-infusion levels. In one embodiment, an IDPN composition is
effective to achieve mid-infusion blood glucose levels less than 2%
higher than pre-infusion levels. In one embodiment, an IDPN
composition is effective to achieve mid-infusion blood glucose
levels less than 5% higher than pre-infusion levels. In one
embodiment, an IDPN composition is effective to achieve
mid-infusion blood glucose levels less than 10% higher than
pre-infusion levels. In one embodiment, an IDPN composition is
effective to achieve mid-infusion blood glucose levels less than
15% higher than pre-infusion levels. In one embodiment, an IDPN
composition is effective to achieve mid-infusion blood glucose
levels less than 20% higher than pre-infusion levels. In one
embodiment, an IDPN composition is effective to achieve
mid-infusion blood glucose levels less than 25% higher than
pre-infusion levels. In one embodiment, an IDPN composition is
effective to achieve mid-infusion blood glucose levels less than
30% higher than pre-infusion levels. In one embodiment, an IDPN
composition is effective to achieve mid-infusion blood glucose
levels less than 35% higher than pre-infusion levels.
[0144] In another embodiment, an IDPN composition is effective to
achieve mid-infusion blood glucose level 1% to 10% higher than
pre-infusion levels. In another embodiment, an IDPN composition is
effective to achieve mid-infusion blood glucose level 5% to 25%
higher than pre-infusion levels. In another embodiment, an IDPN
composition is effective to achieve mid-infusion blood glucose
level 10% to 35% higher than pre-infusion levels. In another
embodiment, an IDPN composition is effective to achieve
mid-infusion blood glucose level 15% to 35% higher than
pre-infusion levels. In another embodiment, an IDPN composition is
effective to achieve mid-infusion blood glucose level 2% to 20%
higher than pre-infusion levels.
[0145] In one embodiment, a modulation in blood glucose levels is
observable within about an hour, within about 4 hours, within about
8 hours, within about 12 hours, within about 24 hours, within about
2 days, within about 3 days, within about 4 days, within about 5
days, within about 6 days, or within about 7 days. In another
embodiment, a modulation in blood glucose levels is observable
within about a month, within about 2 months, within about 3 months,
within about 4 months, within about 5 months, within about 6
months, within about 7 months, within about 8 months, within about
9 months, within about 10 months, within about 11 months, or within
about 12 months. In another embodiment, a modulation in blood
glucose levels is observable within about 6 months. In another
embodiment, a modulation in blood glucose levels is observable
within about a year. In another embodiment, a modulation in blood
glucose levels is observable within about 1 hour to about 4 hours.
In another embodiment, a modulation in blood glucose levels is
observable within about 1 hour to about 8 hours. In another
embodiment, a modulation in blood glucose levels is observable
within about 1 day to about 7 days. In another embodiment, a
modulation in blood glucose levels is observable within about 1
week to about 3 weeks.
Administration of IDPN Compositions
[0146] In one embodiment, an IDPN composition is administered
weekly. In another embodiment, an IDPN composition is administered
daily. In another embodiment, an IDPN composition is administered
at least once a day. In another embodiment, an IDPN composition is
administered more than once a day. In another embodiment, an IDPN
composition is administered 1, 2, 3, 4, 5, 6, or 7 times a week. In
another embodiment, an IDPN composition is administered 3 days a
week. In another embodiment, an IDPN composition is administered 2
days a week. In another embodiment, an IDPN composition is
administered 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 times a day. In
another embodiment, an IDPN composition is administered 1, 2, 3, 4,
5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22,
23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39,
40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56,
57, 58, 59, 60, 61, 62, 63, 64, 65, 66, 67, 68, 69, or 70 times a
week. In another embodiment, an IDPN composition is administered
from about 1 to about 10 times a day. In another embodiment, an
IDPN composition is administered from about 1 to about 5 times a
day. In another embodiment, an IDPN composition is administered 1
to 3 times a day. In another embodiment, an IDPN composition is
administered about 1 to about 100 times a week. In another
embodiment, an IDPN composition is administered about 5 to about 50
times a week. In another embodiment, an IDPN composition is
administered about 7 to about 35 times a week. In another
embodiment, an IDPN composition is administered about 7 to about 21
times a week. In another embodiment, the administrations are spread
out evenly over a time period. In another embodiment, an IDPN
composition is administered as needed. In another embodiment, an
IDPN composition is administered at the discretion of a health care
provider. In another embodiment, IDPN compositions are administered
as per a regimen.
[0147] In one embodiment, a dose is administered over an infusion
time. In another embodiment, an infusion time is less than about 8
hours. In another embodiment, an infusion time is less than about 6
hours. In another embodiment, an infusion time is less than about 4
hours. In another embodiment, an infusion time is less than about 2
hours. In another embodiment, an infusion time is from about 2
hours to about 8 hours. In another embodiment, an infusion time is
from about 3 hours to about 5 hours. In another embodiment, an
infusion time is about 2 hours, about 2.25 hours, about 2.5 hours,
about 2.75 hours, about 3 hours, about 3.25 hours, about 3.5 hours,
about 3.75 hours, or about 4 hours. In another embodiment, an
infusion time is about 2.75-3 hours. In another embodiment, an
infusion time is about 3-3.25 hours. In another embodiment, an
infusion time is about 3.25-3.5 hours. In another embodiment, an
infusion time is about 3.5-3.75 hours. In another embodiment, an
infusion time is about 3.75-4 hours.
[0148] In one embodiment, an infusion time is optionally extended
by an additional period. In another embodiment, an infusion time is
extended by an additional period. In another embodiment, an
additional period improves the efficacy of infusion of an IDPN
composition into the subject. In another embodiment, an additional
period precedes the infusion time. In another embodiment, an
additional period follows the infusion time. In another embodiment,
an infusion time is interrupted by one or more additional periods.
In another embodiment, an additional period is greater than about
0.05 hours. In another embodiment, an additional period is greater
than about 0.20 hours. In another embodiment, an additional period
is less than about 1.0 hours. In another embodiment, an additional
period is less than about 0.55 hours. In another embodiment, an
additional period is from about 0.05 hours to about 1.0 hours. In
another embodiment, an additional period is from about 0.10 hours
to about 0.50 hours. In another embodiment, an additional period is
about 0.05 hours, about 0.10 hours, about 0.15 hours, about 0.20
hours, about 0.25 hours, about 0.30 hours, about 0.35 hours, about
0.40 hours, about 0.45 hours, or about 0.50 hours. In another
embodiment, an additional period is about 0.25 hours. In another
embodiment, an additional period follows an infusion time and is
0.25 hours.
[0149] In one embodiment, an infusion time is about 2.00 hours
extended by an additional period of about 0.25 hours. In another
embodiment, an infusion time is about 2.25 hours extended by an
additional period of about 0.25 hours. In another embodiment, an
infusion time is about 2.50 hours extended by an additional period
of about 0.25 hours. In another embodiment, an infusion time is
about 2.75 hours extended by an additional period of about 0.25
hours. In another embodiment, an infusion time is about 3.00 hours
extended by an additional period of about 0.25 hours. In another
embodiment, an infusion time is about 3.25 hours extended by an
additional period of about 0.25 hours. In another embodiment, an
infusion time is about 3.50 hours extended by an additional period
of about 0.25 hours. In another embodiment, an infusion time is
about 3.75 hours extended by an additional period of about 0.25
hours. In another embodiment, an infusion time is about 4.00 hours
extended by an additional period of about 0.25 hours. In another
embodiment, an infusion time is about 2.00 hours extended by an
additional period of about 0.50 hours. In another embodiment, an
infusion time is about 2.25 hours extended by an additional period
of about 0.50 hours. In another embodiment, an infusion time is
about 2.50 hours extended by an additional period of about 0.50
hours. In another embodiment, an infusion time is about 2.75 hours
extended by an additional period of about 0.50 hours. In another
embodiment, an infusion time is about 3.00 hours extended by an
additional period of about 0.50 hours. In another embodiment, an
infusion time is about 3.25 hours extended by an additional period
of about 0.50 hours. In another embodiment, an infusion time is
about 3.50 hours extended by an additional period of about 0.50
hours.
[0150] In another embodiment, an infusion time is about 3.75 hours
extended by an additional period of about 0.50 hours. In another
embodiment, an infusion time is about 4.00 hours extended by an
additional period of about 0.50 hours.
[0151] In one embodiment, a dose is administered at an infusion
rate. In another embodiment, an infusion rate is directly
proportionate to the body mass of the subject. In another
embodiment, an infusion rate is modulated as therapy progresses for
a subject. In another embodiment an infusion rate during the second
week of therapy is greater than an infusion rate during the first
week of therapy for a given subject. In another embodiment, an
infusion rate during the second week of therapy is about 1.5 times
greater than an infusion rate during the first week of therapy for
a given subject. In another embodiment, an infusion rate during the
second week of therapy is about 2 times greater than an infusion
rate during the first week of therapy for a given subject. In
another embodiment, an infusion rate during the second week of
therapy is about 3 times greater than an infusion rate during the
first week of therapy for a given subject.
[0152] In one embodiment, an infusion rate is greater than about 10
mL/hour. In another embodiment, an infusion rate is less than about
300 mL/hour. In another embodiment, an infusion rate is from about
10 mL/hour to about 300 mL/hour. In another embodiment, an infusion
rate is about 10 mL/hour, about 11 mL/hour, about 12 mL/hour, about
13 mL/hour, about 14 mL/hour, about 15 mL/hour, about 16 mL/hour,
about 17 mL/hour, about 18 mL/hour, about 19 mL/hour, about 20
mL/hour, about 21 mL/hour, about 22 mL/hour, about 23 mL/hour,
about 24 mL/hour, about 25 mL/hour, about 26 mL/hour, about 27
mL/hour, about 28 mL/hour, about 29 mL/hour, about 30 mL/hour,
about 31 mL/hour, about 32 mL/hour, about 33 mL/hour, about 34
mL/hour, about 35 mL/hour, about 36 mL/hour, about 37 mL/hour,
about 38 mL/hour, about 39 mL/hour, about 40 mL/hour, about 41
mL/hour, about 42 mL/hour, about 43 mL/hour, about 44 mL/hour,
about 45 mL/hour, about 46 mL/hour, about 47 mL/hour, about 48
mL/hour, about 49 mL/hour, about 50 mL/hour, 51 mL/hour, about 52
mL/hour, about 53 mL/hour, about 54 mL/hour, about 55 mL/hour,
about 56 mL/hour, about 57 mL/hour, about 58 mL/hour, about 59
mL/hour, about 60 mL/hour, about 61 mL/hour, about 62 mL/hour,
about 63 mL/hour, about 64 mL/hour, about 65 mL/hour, about 66
mL/hour, about 67 mL/hour, about 68 mL/hour, about 69 mL/hour,
about 70 mL/hour, about 71 mL/hour, about 72 mL/hour, about 73
mL/hour, about 74 mL/hour, about 75 mL/hour, about 76 mL/hour,
about 77 mL/hour, about 78 mL/hour, about 79 mL/hour, about 80
mL/hour, about 81 mL/hour, about 82 mL/hour, about 83 mL/hour,
about 84 mL/hour, about 85 mL/hour, about 86 mL/hour, about 87
mL/hour, about 88 mL/hour, about 89 mL/hour, about 90 mL/hour,
about 91 mL/hour, about 92 mL/hour, about 93 mL/hour, about 94
mL/hour, about 95 mL/hour, about 96 mL/hour, about 97 mL/hour,
about 98 mL/hour, about 99 mL/hour, about 100 mL/hour, about 101
mL/hour, about 102 mL/hour, about 103 mL/hour, about 104 mL/hour,
about 105 mL/hour, about 106 mL/hour, about 107 mL/hour, about 108
mL/hour, about 109 mL/hour, about 110 mL/hour, about 111 mL/hour,
about 112 mL/hour, about 113 mL/hour, about 114 mL/hour, about 115
mL/hour, about 116 mL/hour, about 117 mL/hour, about 118 mL/hour,
about 119 mL/hour, about 120 mL/hour, about 121 mL/hour, about 122
mL/hour, about 123 mL/hour, about 124 mL/hour, about 125 mL/hour,
about 126 mL/hour, about 127 mL/hour, about 128 mL/hour, about 129
mL/hour, about 130 mL/hour, about 131 mL/hour, about 132 mL/hour,
about 133 mL/hour, about 134 mL/hour, about 135 mL/hour, about 136
mL/hour, about 137 mL/hour, about 138 mL/hour, about 139 mL/hour,
about 140 mL/hour, about 141 mL/hour, about 142 mL/hour, about 143
mL/hour, about 144 mL/hour, about 145 mL/hour, about 146 mL/hour,
about 147 mL/hour, about 148 mL/hour, about 149 mL/hour, about 150
mL/hour, about 151 mL/hour, about 152 mL/hour, about 153 mL/hour,
about 154 mL/hour, about 155 mL/hour, about 156 mL/hour, about 157
mL/hour, about 158 mL/hour, about 159 mL/hour, about 160 mL/hour,
about 161 mL/hour, about 162 mL/hour, about 163 mL/hour, about 164
mL/hour, about 165 mL/hour, about 166 mL/hour, about 167 mL/hour,
about 168 mL/hour, about 169 mL/hour, about 170 mL/hour, about 171
mL/hour, about 172 mL/hour, about 173 mL/hour, about 174 mL/hour,
about 175 mL/hour, about 176 mL/hour, about 177 mL/hour, about 178
mL/hour, about 179 mL/hour, about 180 mL/hour, about 181 mL/hour,
about 182 mL/hour, about 183 mL/hour, about 184 mL/hour, about 185
mL/hour, about 186 mL/hour, about 187 mL/hour, about 188 mL/hour,
about 189 mL/hour, about 190 mL/hour, about 191 mL/hour, about 192
mL/hour, about 193 mL/hour, about 194 mL/hour, about 195 mL/hour,
about 196 mL/hour, about 197 mL/hour, about 198 mL/hour, about 199
mL/hour, about 200 mL/hour, about 201 mL/hour, about 202 mL/hour,
about 203 mL/hour, about 204 mL/hour, about 205 mL/hour, about 206
mL/hour, about 207 mL/hour, about 208 mL/hour, about 209 mL/hour,
about 210 mL/hour, about 211 mL/hour, about 212 mL/hour, about 213
mL/hour, about 214 mL/hour, about 215 mL/hour, about 216 mL/hour,
about 217 mL/hour, about 218 mL/hour, about 219 mL/hour, about 220
mL/hour, about 221 mL/hour, about 222 mL/hour, about 223 mL/hour,
about 224 mL/hour, about 225 mL/hour, about 226 mL/hour, about 227
mL/hour, about 228 mL/hour, about 229 mL/hour, about 230 mL/hour,
about 231 mL/hour, about 232 mL/hour, about 233 mL/hour, about 234
mL/hour, about 235 mL/hour, about 236 mL/hour, about 237 mL/hour,
about 238 mL/hour, about 239 mL/hour, about 240 mL/hour, about 241
mL/hour, about 242 mL/hour, about 243 mL/hour, about 244 mL/hour,
about 245 mL/hour, about 246 mL/hour, about 247 mL/hour, about 248
mL/hour, about 249 mL/hour, about 250 mL/hour, about 251 mL/hour,
about 252 mL/hour, about 253 mL/hour, about 254 mL/hour, about 255
mL/hour, about 256 mL/hour, about 257 mL/hour, about 258 mL/hour,
about 259 mL/hour, about 260 mL/hour, about 261 mL/hour, about 262
mL/hour, about 263 mL/hour, about 264 mL/hour, about 265 mL/hour,
about 266 mL/hour, about 267 mL/hour, about 268 mL/hour, about 269
mL/hour, about 270 mL/hour, about 271 mL/hour, about 272 mL/hour,
about 273 mL/hour, about 274 mL/hour, about 275 mL/hour, about 276
mL/hour, about 277 mL/hour, about 278 mL/hour, about 279 mL/hour,
about 280 mL/hour, about 281 mL/hour, about 282 mL/hour, about 283
mL/hour, about 284 mL/hour, about 285 mL/hour, about 286 mL/hour,
about 287 mL/hour, about 288 mL/hour, about 289 mL/hour, about 290
mL/hour, about 291 mL/hour, about 292 mL/hour, about 293 mL/hour,
about 294 mL/hour, about 295 mL/hour, about 296 mL/hour, about 297
mL/hour, about 298 mL/hour, about 299 mL/hour, or about 300
mL/hour.
[0153] In one embodiment, a modulation in albumin levels is
determined by analyzing the blood of a subject. In another
embodiment, an increase in albumin levels is determined by
analyzing the blood of a subject.
[0154] In one embodiment, hemodialysis with an IDPN composition
provides an IDPN composition with reduced infusion volume. In
another embodiment, reduced infusion volume reduces one or more
side effects associated with a high infusion volume. In another
embodiment, a side effect associated with a high infusion volume is
dyspnea, increased respiratory rate, rhonchi, edema, hypertension,
hernia, or anxiety. In another embodiment, hemodialysis with an
IDPN composition provides an IDPN composition with reduced symptoms
associated with hyperglycemia. In another embodiment, a symptom
associated with hyperglycemia is excessive thirst, excessive
urination, physical exhaustion, involuntary weight loss, yeast or
fungal infection, blurred vision, numbness, confusion, coma, or a
symptom associated with diabetes type 2. In another embodiment, a
symptom associated with diabetes type 2 is skin rash, skin
infection, athlete's foot, poor skin healing, urinary tract
infection, candida, thrush, dry itchy skin, flaky skin, skin
ulcers, peripheral neuropathy, paresthesias, foot tingling, foot
numbness, hand tingling, hand numbness, blurred vision, sexual
dysfunction, erectile failure, vaginal dryness, premature
menopause, absent periods, involuntary weight gain, drowsiness,
malaise, dehydration, bedwetting, excessive hunger, muscle cramps,
muscle aches, headaches, irritability, fatigue, muscle weakness,
acne, hyperglycemic hyperosmolar nonketoic syndrome, diabetic
ketoacidosis, nausea, vomiting, respiratory difficulty, rapid
pulse, or abdominal pain. In another embodiment, hemodialysis with
an IDPN composition provides hemodialysis with reduced side effects
associated with a high infusion volume and with reduced symptoms
associated with hyperglycemia.
[0155] In another embodiment, an IDPN composition comprises one or
more agents effective to increase albumin levels in a subject. In
another embodiment, an IDPN composition is co-administered with one
or more agents effective to increase albumin levels in a subject.
In another embodiment, co-administration of an agent effective to
increase albumin levels in a subject takes place prior to
administration of an IDPN composition. In another embodiment,
co-administration of an agent effective to increase albumin levels
in a subject takes place during administration of an IDPN
composition. In another embodiment, co-administration of an agent
effective to increase albumin levels in a subject takes place after
administration of an IDPN composition. In another embodiment, a
subject treated with an IDPN composition is also treated with an
appetite stimulant. In another embodiment, an IDPN composition is
co-administered with one or more appetite stimulants. In another
embodiment, co-administration of an appetite stimulant takes place
prior to administration of an IDPN composition. In another
embodiment, co-administration of an appetite stimulant takes place
during administration of an IDPN composition. In another
embodiment, co-administration of an appetite stimulant takes place
after administration of an IDPN composition. Non-limiting examples
of appetite stimulants include marinol, cyprohepatadine, megestrol
acetate, and pizotifen. In another embodiment, an IDPN composition
is co-administered with megestrol acetate.
[0156] In one embodiment, an IDPN composition is administered using
a dialysis machine. Non-limiting examples of dialysis machines that
are compatable with IDPN compositions of the instant invention
include a Fresenius 2008 series, a B.Braun Dialog+, a Gambro
Phoenix System, a Redy 2000, a Baxter SPS550/1550, an Althin 1000,
an Althin Altratouch 1000, an Althin Tina, a Meridian, an Aurora
system 1000, a NxStage System One with Pure Flow, and a Fresinius
2008K At Home.
[0157] A Fresinius 2008 series is characterized by a pliable venous
drip chamber comprising beveled downspouts resulting in low
turbulence and reduced foaming, reduced resistance to flow, thereby
reducing the potential for clotting, and thick-walled
kink-resistant blood tubing.
[0158] A B.Braun Dialog+ is characterized by a bicarbonate
cartridge holder, and an UltraPureFluid-System and Diacap.RTM.
Ultra pyrogen filter to produce pure dialysate thereby reducing the
risk of contaminated dialysis fluid and complications arising from
the same.
[0159] A Gambro Phoenix System is characterized by online mixing of
sterile dry bicarbonate, bloodlines with low extracorporeal blood
volume, simplified priming thereby eliminating the need to reverse
the dialyzer, and the absence of a priming bucket.
[0160] A Redy 2000 is characterized by self-containment,
portability, a built-in blood pump, and a built-in foam
detector.
[0161] A Baxter SPS550/1550 is characterized by an internally
regulated pressure of 70 Kpa (10 psi) after the inlet water
pressure regulator, and 100 KPa (15 psi) after the proportioning
pump pressure regulator.
[0162] An Althin 1000 is characterized by a pressure measurement
that detects backfiltration, and an integrated intelligent single
needle.
[0163] An Althin Altratouch 1000 is characterized by reliable
monitoring of very low flow rates.
[0164] An Althin Tina is characterized by a hydraulic module that
swings out of the body of the machine out on a door, and a small
number of openings into the machine.
[0165] A Meridian is characterized by prevention of an excessive
loss of water from the blood of a subject, the ability to function
with a carbonate concentrate or an acetate concentrate, and
automated chemical disinfection.
[0166] An Aurora system 1000 is characterized by prevention of an
excessive loss of water from the blood of a subject, the ability to
function with a carbonate concentrate or an acetate concentrate,
and the ability to prepare dialysate from a concentrate.
[0167] A NxStage System One with Pure Flow is characterized by
small size and portability, thereby enabling hemodialysis at home
and during travel, compatibility with common household electrical
and plumbing facilities, a compact water purification system, the
ability to prepare dialysate from tap water thereby eliminating the
need for a large external water purification system, and built-in
water purity sensors.
[0168] A Fresenius 2008K At Home is characterized by enabling
hemodialysis at home, a pliable venous drip chamber comprising
beveled downspouts resulting in low turbulence and reduced foaming,
reduced resistance to flow, thereby reducing the potential for
clotting, and thick-walled kink-resistant blood tubing.
[0169] In one embodiment, administration comprises dialysis. In
another embodiment, administration takes place in a health care
facility. In another embodiment, administration takes place outside
of a healthcare facility. In another embodiment, administration
takes place in the home of the subject. In another embodiment,
administration takes place in the home of the subject using a
NxStage System One with Pure Flow dialysis machine.
[0170] In one embodiment, a dialysis machine comprises one or more
blood lines. In another embodiment, a blood line is compatible with
an IDPN composition. In another embodiment, a dialysis machine
comprises a venous drip chamber. In another embodiment, a venous
drip chamber comprises a pigtail In one embodiment, a hemodialysis
system is composed of two major subsystems, a dialysate delivery
system and an extracorporeal blood circuit. In another embodiment,
an extracorporeal blood circuit is compatible with an IDPN
composition. In another embodiment, an extracorporeal circuit
comprises a venous drip chamber. In another embodiment the venous
drip chamber comprises a venous medication infusion luer lock line.
In another embodiment, a venous medication infusion luer lock line
is an access port outside the human body. In another embodiment, a
venous medication infusion luer lock line is compatible with IDPN
composition. In another embodiment, an IDPN composition is
administered to the subject via the venous medication infusion luer
lock line. In another embodiment, an IDPN composition enters the
blood of the subject via the venous medication infusion luer lock
line. In another embodiment, the subjects blood travels through the
venous portion of the extracorporeal circuit, and into the subjects
body. In another embodiment, an IDPN composition is administered by
a route other than the venous medication infusion luer lock line.
In another embodiment, an IDPN composition is administered to a
subject by a route other than a pigtail.
[0171] In one embodiment, an IDPN composition is administered to a
dialysis subject. In another embodiment, a subject is suffering
from malnutrition. In another embodiment, a subject is in need or
want of nutrition. In another embodiment, a subject is in need or
want of a therapy for malnutrition. In another embodiment, a
dialysis subject suffering from malnutrition is identified by
detecting: evidence of protein or energy malnutrition and
inadequate dietary protein intake, evidence of the inability to
administer or tolerate adequate oral nutrition inclusive of
supplements and tube feeding, and evidence that the combination or
oral and/or enteral intake when combined with an IDPN composition
of the instant invention will meet the subject's nutritional
needs.
[0172] Administration of an IDPN composition generally coincides
with the start of hemodialysis on a subject. During IDPN
composition administration, a subject is monitored for glucose
tolerance, protein load and/or fat tolerance. Glucose monitoring
includes blood glucose level before, during and after IDPN
administration and monitoring a subject for symptoms of hyper or
hypoglycemia. The symptoms of hyperglycemia include nausea, thirst,
headache, vomiting and weakness. The symptoms of hypoglycemia
include headache, dizziness, tremors, cold sweat, confusion, and
faintness. The presence of hyper or hypoglycemia can then be
confirmed through blood sugar analysis, such as via a fingerstick
or arterial glucose level. In one embodiment, insulin is
administered, thereby treating hyperglycemia. In one embodiment, a
subject receives about 20 to about 30 g of simple carbohydrates
orally, thereby treating hypoglycemia. Protein monitoring includes
the monitoring of blood urea nitrogen (BUN) prior to dialysis and
Kt/V, which is a measure of dialysis adequacy.
[0173] Fat monitoring includes a pre-dialysis triglyceride test
prior to a lipid infusion and then another following the lipid
infusion to ensure that the subject is clearing lipids from the
bloodstream. In one embodiment, sodium, potassium, phosphorus and
magnesium levels are monitored for the presence of refeeding
syndrome.
[0174] In one embodiment, an IDPN composition is administered
through a port post dialyzer of the dialysis machine being used to
perform hemodialysis on the subject. In another embodiment, the
administration is performed through the venous chamber of the
dialysis machine. An IDPN composition is administered by any
suitable method known to a practitioner of hemodialysis.
[0175] Hemodialysis in general uses diffusion to remove waste
products from a subject blood. A diffusive gradient that occurs
across a semi-permeable dialyzer between the blood and an
electrolyte solution, called dialysate, causes diffusion. In one
embodiment, the hemodialysis takes place in a health care facility.
In another embodiment, the hemodialysis takes place in a clinic. In
another embodiment, the hemodialysis takes place in a hospital. In
another embodiment, the hemodialysis takes place in a dialysis
unit. In one embodiment, the hemodialysis takes place in the home
of the subject. In another embodiment, the dialysis machine is a
home system. In another embodiment, a home system comprises a
mobile cart and integral bag manager. In another embodiment, the
dialysis machine accepts a dose of an IDPN composition. In another
embodiment, the dialysis machine accepts multiple doses of an IDPN
composition. In another embodiment, a dialysis machine accepts 1,
2, 3, 4, 5, 6, 7, 8, 9, or 10 doses of an IDPN composition. In
another embodiment, a dialysis machine accepts a dose in the form
of a bag. In another embodiment, a dialysis machine accepts bags of
a certain size. In another embodiment, a dialysis machine accepts
bags of various sizes. In another embodiment, the sizes of the bags
are as described herein.
[0176] In one embodiment, the invention provides methods for the
treatment of malnutrition in a subject in need or want thereof,
using the systems, devices, and IDPN compositions described
herein.
[0177] In one embodiment, the invention provides a method for
treating or preventing malnutrition in a subject in need or want
thereof, the method comprising: a) formulating an aqueous
composition comprising carbohydrates, amino acids, and optionally
one or more of lipids and micronutrients, wherein the amount of
each of the carbohydrates, the amino acids, the lipids, and the
micronutrients is related to the body mass of the subject and
optionally to the age of the subject; and b) infusing the
composition into the subject at an infusion rate, wherein the
infusion rate is related to the body mass of the subject and
optionally to the age of the subject.
[0178] In one embodiment, the invention provides a method for
treating or preventing malnutrition in a subject in need or want
thereof, the method comprising: a) formulating an aqueous
composition comprising carbohydrates, amino acids, and optionally
one or more of lipids and micronutrients, wherein the amount of
each of the carbohydrates, the amino acids, the lipids, and the
micronutrients is related to the body mass of the subject and
optionally to the age of the subject; and b) infusing the
composition into the subject at an infusion rate, wherein the
infusion rate is related to the body mass of the subject and
optionally to the age of the subject. In another embodiment, the
body mass is from 9 to 39 kg. In another embodiment, the body mass
is from 34 to greater than 70 kg.
[0179] In one embodiment, the invention provides a method for
treating or preventing malnutrition in a subject in need or want
thereof, the method comprising: a) formulating an aqueous
composition comprising carbohydrates and amino acids, wherein the
amount of each of the carbohydrates and the amino acids is related
to the body mass of the subject and optionally to the age of the
subject; and b) infusing the composition into the subject at an
infusion rate, wherein the infusion rate is related to the body
mass of the subject and optionally to the age of the subject. In
another embodiment, the body mass is from 9 to 39 kg. In another
embodiment, the body mass is from 34 to greater than 70 kg.
[0180] In one embodiment, the invention provides a method for
treating or preventing malnutrition in a subject in need or want
thereof, the method comprising: a) formulating an aqueous
composition comprising carbohydrates, amino acids, and
micronutrients, wherein the amount of each of the carbohydrates,
the amino acids, and the micronutrients is related to the body mass
of the subject and optionally to the age of the subject; and b)
infusing the composition into the subject at an infusion rate,
wherein the infusion rate is related to the body mass of the
subject and optionally to the age of the subject. In another
embodiment, the body mass is from 9 to 39 kg. In another
embodiment, the body mass is from 34 to greater than 70 kg.
[0181] In one embodiment, the invention provides a method for
treating or preventing malnutrition in a subject in need or want
thereof, the method comprising: a) formulating an aqueous
composition comprising carbohydrates, amino acids, and lipids,
wherein the amount of each of the carbohydrates, the amino acids,
and lipids is related to the body mass of the subject and
optionally to the age of the subject; and b) infusing the
composition into the subject at an infusion rate, wherein the
infusion rate is related to the body mass of the subject and
optionally to the age of the subject. In another embodiment, the
body mass is from 9 to 39 kg. In another embodiment, the body mass
is from 34 to greater than 70 kg.
[0182] In one embodiment, the invention provides a method for
treating or preventing malnutrition in a subject in need or want
thereof, the method comprising: a) formulating an aqueous
composition comprising carbohydrates, amino acids, lipids and
micronutrients, wherein the amount of each of the carbohydrates,
the amino acids, the lipids, and the micronutrients is related to
the body mass of the subject and optionally to the age of the
subject; and b) infusing the composition into the subject at an
infusion rate, wherein the infusion rate is related to the body
mass of the subject and optionally to the age of the subject. In
another embodiment, the body mass is from 9 to 39 kg. In another
embodiment, the body mass is from 34 to greater than 70 kg.
[0183] In one embodiment, the invention provides a method for
treating or preventing malnutrition in a subject in need or want
thereof, the method comprising: a) formulating an aqueous
composition comprising carbohydrates, amino acids, and optionally
one or more of lipids and micronutrients, wherein the amount of
each of the carbohydrates, the amino acids, the lipids, and the
micronutrients is related to the body mass of the subject; and b)
infusing the composition into the subject at an infusion rate,
wherein the infusion rate is related to the body mass of the
subject. In another embodiment, the body mass is from 9 to 39 kg.
In another embodiment, the body mass is from 34 to greater than 70
kg.
[0184] In one embodiment, the invention provides a method for
treating or preventing malnutrition in a subject in need or want
thereof, the method comprising: a) formulating an aqueous
composition comprising carbohydrates and amino acids, wherein the
amount of each of the carbohydrates and the amino acids is related
to the body mass of the subject; and b) infusing the composition
into the subject at an infusion rate, wherein the infusion rate is
related to the body mass of the subject. In another embodiment, the
body mass is from 9 to 39 kg. In another embodiment, the body mass
is from 34 to greater than 70 kg.
[0185] In one embodiment, the invention provides a method for
treating or preventing malnutrition in a subject in need or want
thereof, the method comprising: a) formulating an aqueous
composition comprising carbohydrates, amino acids, and
micronutrients, wherein the amount of each of the carbohydrates,
the amino acids, and the micronutrients is related to the body mass
of the subject; and b) infusing the composition into the subject at
an infusion rate, wherein the infusion rate is related to the body
mass of the subject. In another embodiment, the body mass is from 9
to 39 kg. In another embodiment, the body mass is from 34 to
greater than 70 kg.
[0186] In one embodiment, the invention provides a method for
treating or preventing malnutrition in a subject in need or want
thereof, the method comprising: a) formulating an aqueous
composition comprising carbohydrates, amino acids, and lipids,
wherein the amount of each of the carbohydrates, the amino acids,
and lipids is related to the body mass of the subject; and b)
infusing the composition into the subject at an infusion rate,
wherein the infusion rate is related to the body mass of the
subject.
[0187] In one embodiment, the invention provides a method for
treating or preventing malnutrition in a subject in need or want
thereof, the method comprising: a) formulating an aqueous
composition comprising carbohydrates, amino acids, lipids and
micronutrients, wherein the amount of each of the carbohydrates,
the amino acids, the lipids, and the micronutrients is related to
the body mass of the subject; and b) infusing the composition into
the subject at an infusion rate, wherein the infusion rate is
related to the body mass of the subject. In another embodiment, the
body mass is from 9 to 39 kg. In another embodiment, the body mass
is from 34 to greater than 70 kg.
[0188] In one embodiment, the invention provides a method for
treating or preventing malnutrition in a subject in need or want
thereof, the method comprising: a) formulating an aqueous
composition comprising carbohydrates, amino acids, and optionally
one or more of lipids and micronutrients, wherein the amount of
each of the carbohydrates, the amino acids, the lipids, and the
micronutrients is related to the estimated dry weight of the
subject and optionally to the age of the subject; and b) infusing
the composition into the subject at an infusion rate, wherein the
infusion rate is related to the estimated dry weight of the subject
and optionally to the age of the subject. In another embodiment,
the estimated dry weight is from 9 to 39 kg. In another embodiment,
the estimated dry weight is from 34 to greater than 70 kg.
[0189] In one embodiment, the invention provides a method for
treating or preventing malnutrition in a subject in need or want
thereof, the method comprising: a) formulating an aqueous
composition comprising carbohydrates and amino acids, wherein the
amount of each of the carbohydrates and the amino acids is related
to the estimated dry weight of the subject and optionally to the
age of the subject; and b) infusing the composition into the
subject at an infusion rate, wherein the infusion rate is related
to the estimated dry weight of the subject and optionally to the
age of the subject. In another embodiment, the estimated dry weight
is from 9 to 39 kg. In another embodiment, the estimated dry weight
is from 34 to greater than 70 kg.
[0190] In one embodiment, the invention provides a method for
treating or preventing malnutrition in a subject in need or want
thereof, the method comprising: a) formulating an aqueous
composition comprising carbohydrates, amino acids, and
micronutrients, wherein the amount of each of the carbohydrates,
the amino acids, and the micronutrients is related to the estimated
dry weight of the subject and optionally to the age of the subject;
and b) infusing the composition into the subject at an infusion
rate, wherein the infusion rate is related to the estimated dry
weight of the subject and optionally to the age of the subject. In
another embodiment, the estimated dry weight is from 9 to 39 kg. In
another embodiment, the estimated dry weight is from 34 to greater
than 70 kg.
[0191] In one embodiment, the invention provides a method for
treating or preventing malnutrition in a subject in need or want
thereof, the method comprising: a) formulating an aqueous
composition comprising carbohydrates, amino acids, and lipids,
wherein the amount of each of the carbohydrates, the amino acids,
and lipids is related to the estimated dry weight of the subject
and optionally to the age of the subject; and b) infusing the
composition into the subject at an infusion rate, wherein the
infusion rate is related to the estimated dry weight of the subject
and optionally to the age of the subject. In another embodiment,
the estimated dry weight is from 9 to 39 kg. In another embodiment,
the estimated dry weight is from 34 to greater than 70 kg.
[0192] In one embodiment, the invention provides a method for
treating or preventing malnutrition in a subject in need or want
thereof, the method comprising: a) formulating an aqueous
composition comprising carbohydrates, amino acids, lipids and
micronutrients, wherein the amount of each of the carbohydrates,
the amino acids, the lipids, and the micronutrients is related to
the estimated dry weight of the subject and optionally to the age
of the subject; and b) infusing the composition into the subject at
an infusion rate, wherein the infusion rate is related to the
estimated dry weight of the subject and optionally to the age of
the subject. In another embodiment, the estimated dry weight is
from 9 to 39 kg. In another embodiment, the estimated dry weight is
from 34 to greater than 70 kg.
[0193] In one embodiment, the invention provides a method for
treating or preventing malnutrition in a subject in need or want
thereof, the method comprising: a) formulating an aqueous
composition comprising carbohydrates, amino acids, and optionally
one or more of lipids and micronutrients, wherein the amount of
each of the carbohydrates, the amino acids, the lipids, and the
micronutrients is related to the estimated dry weight of the
subject; and b) infusing the composition into the subject at an
infusion rate, wherein the infusion rate is related to the
estimated dry weight of the subject. In another embodiment, the
estimated dry weight is from 9 to 39 kg. In another embodiment, the
estimated dry weight is from 34 to greater than 70 kg.
[0194] In one embodiment, the invention provides a method for
treating or preventing malnutrition in a subject in need or want
thereof, the method comprising: a) formulating an aqueous
composition comprising carbohydrates and amino acids, wherein the
amount of each of the carbohydrates and the amino acids is related
to the estimated dry weight of the subject; and b) infusing the
composition into the subject at an infusion rate, wherein the
infusion rate is related to the estimated dry weight of the
subject. In another embodiment, the estimated dry weight is from 9
to 39 kg. In another embodiment, the estimated dry weight is from
34 to greater than 70 kg.
[0195] In one embodiment, the invention provides a method for
treating or preventing malnutrition in a subject in need or want
thereof, the method comprising: a) formulating an aqueous
composition comprising carbohydrates, amino acids, and
micronutrients, wherein the amount of each of the carbohydrates,
the amino acids, and the micronutrients is related to the estimated
dry weight of the subject; and b) infusing the composition into the
subject at an infusion rate, wherein the infusion rate is related
to the estimated dry weight of the subject. In another embodiment,
the estimated dry weight is from 9 to 39 kg. In another embodiment,
the estimated dry weight is from 34 to greater than 70 kg.
[0196] In one embodiment, the invention provides a method for
treating or preventing malnutrition in a subject in need or want
thereof, the method comprising: a) formulating an aqueous
composition comprising carbohydrates, amino acids, and lipids,
wherein the amount of each of the carbohydrates, the amino acids,
and lipids is related to the estimated dry weight of the subject;
and b) infusing the composition into the subject at an infusion
rate, wherein the infusion rate is related to the estimated dry
weight of the subject. In another embodiment, the estimated dry
weight is from 9 to 39 kg. In another embodiment, the estimated dry
weight is from 34 to greater than 70 kg.
[0197] In one embodiment, the invention provides a method for
treating or preventing malnutrition in a subject in need or want
thereof, the method comprising: a) formulating an aqueous
composition comprising carbohydrates, amino acids, lipids and
micronutrients, wherein the amount of each of the carbohydrates,
the amino acids, the lipids, and the micronutrients is related to
the estimated dry weight of the subject; and b) infusing the
composition into the subject at an infusion rate, wherein the
infusion rate is related to the estimated dry weight of the
subject. In another embodiment, the estimated My weight is from 9
to 39 kg. In another embodiment, the estimated dry weight is from
34 to greater than 70 kg.
[0198] In one embodiment, the invention provides a method for
treating or preventing malnutrition in a subject in need or want
thereof, the method comprising: a) formulating an aqueous
composition comprising carbohydrates, amino acids, and optionally
one or more of lipids and micronutrients, wherein the amount of
each of the carbohydrates, the amino acids, the lipids, and the
micronutrients is related to the ideal body weight of the subject
and optionally to the age of the subject; and b) infusing the
composition into the subject at an infusion rate, wherein the
infusion rate is related to the ideal body weight of the subject
and optionally to the age of the subject. In another embodiment,
the ideal body weight is from 9 to 39 kg. In another embodiment,
the ideal body weight is from 34 to greater than 70 kg.
[0199] In one embodiment, the invention provides a method for
treating or preventing malnutrition in a subject in need or want
thereof, the method comprising: a) formulating an aqueous
composition comprising carbohydrates and amino acids, wherein the
amount of each of the carbohydrates and the amino acids is related
to the ideal body weight of the subject and optionally to the age
of the subject; and b) infusing the composition into the subject at
an infusion rate, wherein the infusion rate is related to the ideal
body weight of the subject and optionally to the age of the
subject. In another embodiment, the ideal body weight is from 9 to
39 kg. In another embodiment, the ideal body weight is from 34 to
greater than 70 kg.
[0200] In one embodiment, the invention provides a method for
treating or preventing malnutrition in a subject in need or want
thereof, the method comprising: a) formulating an aqueous
composition comprising carbohydrates, amino acids, and
micronutrients, wherein the amount of each of the carbohydrates,
the amino acids, and the micronutrients is related to the ideal
body weight of the subject and optionally to the age of the
subject; and b) infusing the composition into the subject at an
infusion rate, wherein the infusion rate is related to the ideal
body weight of the subject and optionally to the age of the
subject. In another embodiment, the ideal body weight is from 9 to
39 kg. In another embodiment, the ideal body weight is from 34 to
greater than 70 kg.
[0201] In one embodiment, the invention provides a method for
treating or preventing malnutrition in a subject in need or want
thereof, the method comprising: a) formulating an aqueous
composition comprising carbohydrates, amino acids, and lipids,
wherein the amount of each of the carbohydrates, the amino acids,
and lipids is related to the ideal body weight of the subject and
optionally to the age of the subject; and b) infusing the
composition into the subject at an infusion rate, wherein the
infusion rate is related to the ideal body weight of the subject
and optionally to the age of the subject. In another embodiment,
the ideal body weight is from 9 to 39 kg. In another embodiment,
the ideal body weight is from 34 to greater than 70 kg.
[0202] In one embodiment, the invention provides a method for
treating or preventing malnutrition in a subject in need or want
thereof, the method comprising: a) formulating an aqueous
composition comprising carbohydrates, amino acids, lipids and
micronutrients, wherein the amount of each of the carbohydrates,
the amino acids, the lipids, and the micronutrients is related to
the ideal body weight of the subject and optionally to the age of
the subject; and b) infusing the composition into the subject at an
infusion rate, wherein the infusion rate is related to the ideal
body weight of the subject and optionally to the age of the
subject. In another embodiment, the ideal body weight is from 9 to
39 kg. In another embodiment, the ideal body weight is from 34 to
greater than 70 kg.
[0203] In one embodiment, the invention provides a method for
treating or preventing malnutrition in a subject in need or want
thereof, the method comprising: a) formulating an aqueous
composition comprising carbohydrates, amino acids, and optionally
one or more of lipids and micronutrients, wherein the amount of
each of the carbohydrates, the amino acids, the lipids, and the
micronutrients is related to the ideal body weight of the subject;
and b) infusing the composition into the subject at an infusion
rate, wherein the infusion rate is related to the ideal body weight
of the subject. In another embodiment, the ideal body weight is
from 9 to 39 kg. In another embodiment, the ideal body weight is
from 34 to greater than 70 kg.
[0204] In one embodiment, the invention provides a method for
treating or preventing malnutrition in a subject in need or want
thereof, the method comprising: a) formulating an aqueous
composition comprising carbohydrates and amino acids, wherein the
amount of each of the carbohydrates and the amino acids is related
to the ideal body weight of the subject; and b) infusing the
composition into the subject at an infusion rate, wherein the
infusion rate is related to the ideal body weight of the subject.
In another embodiment, the ideal body weight is from 9 to 39 kg. In
another embodiment, the ideal body weight is from 34 to greater
than 70 kg.
[0205] In one embodiment, the invention provides a method for
treating or preventing malnutrition in a subject in need or want
thereof, the method comprising: a) formulating an aqueous
composition comprising carbohydrates, amino acids, and
micronutrients, wherein the amount of each of the carbohydrates,
the amino acids, and the micronutrients is related to the ideal
body weight of the subject; and b) infusing the composition into
the subject at an infusion rate, wherein the infusion rate is
related to the ideal body weight of the subject. In another
embodiment, the ideal body weight is from 9 to 39 kg. In another
embodiment, the ideal body weight is from 34 to greater than 70
kg.
[0206] In one embodiment, the invention provides a method for
treating or preventing malnutrition in a subject in need or want
thereof, the method comprising: a) formulating an aqueous
composition comprising carbohydrates, amino acids, and lipids,
wherein the amount of each of the carbohydrates, the amino acids,
and lipids is related to the ideal body weight of the subject; and
b) infusing the composition into the subject at an infusion rate,
wherein the infusion rate is related to the ideal body weight of
the subject. In another embodiment, the ideal body weight is from 9
to 39 kg. In another embodiment, the ideal body weight is from 34
to greater than 70 kg.
[0207] In one embodiment, the invention provides a method for
treating or preventing malnutrition in a subject in need or want
thereof, the method comprising: a) formulating an aqueous
composition comprising carbohydrates, amino acids, lipids and
micronutrients, wherein the amount of each of the carbohydrates,
the amino acids, the lipids, and the micronutrients is related to
the ideal body weight of the subject; and b) infusing the
composition into the subject at an infusion rate, wherein the
infusion rate is related to the ideal body weight of the subject.
In another embodiment, the ideal body weight is from 9 to 39 kg. In
another embodiment, the ideal body weight is from 34 to greater
than 70 kg.
[0208] In one embodiment, the invention provides a method of
treating or preventing malnutrition in a hemodialysis subject in
need thereof comprising determining a body mass of the subject,
wherein if the body mass of the subject is between 9 and 12 kg, the
subject is parenterally administered about 4 g of dextrose and
about 13.5 g of amino acids in about 124 mL of an aqueous
composition; wherein if the body mass of the subject is between 13
and 17 kg, the subject is parenterally administered about 6 g of
dextrose and about 19.5 g of amino acids in about 156 mL of an
aqueous composition; wherein if the body mass of the subject is
between 18 and 22 kg, the subject is parenterally administered
about 9 g of dextrose and about 27 g of amino acids in about 198 mL
of an aqueous composition; wherein if the body mass of the subject
is between 23 and 27 kg, the subject is parenterally administered
about 11 g of dextrose and about 34.5 g of amino acids in about 239
mL of an aqueous composition; wherein if the body mass of the
subject is between 28 and 33 kg, the subject is parenterally
administered about 14 g of dextrose and about 42 g of amino acids
in about 280 mL of an aqueous composition; and wherein if the body
mass of the subject is between 34 and 39 kg, the subject is
parenterally administered about 17 g of dextrose and about 51 g of
amino acids in about 329 mL of an aqueous composition; thereby
treating or preventing malnutrition in the hemodialysis subject in
need thereof.
[0209] In another embodiment, the invention provides a method of
treating or preventing malnutrition in a hemodialysis subject in
need thereof comprising determining a body mass of the subject,
wherein if the body mass of the subject is between 9 and 12 kg, the
subject is parenterally administered about 5 g of dextrose and
about 13.5 g of amino acids in about 125 mL of an aqueous
composition; wherein if the body mass of the subject is between 13
and 17 kg, the subject is parenterally administered about 8 g of
dextrose and about 19.5 g of amino acids in about 158 mL of an
aqueous composition; wherein if the body mass of the subject is
between 18 and 22 kg, the subject is parenterally administered
about 10.5 g of dextrose and about 27 g of amino acids in about 200
mL of an aqueous composition; wherein if the body mass of the
subject is between 23 and 27 kg, the subject is parenterally
administered about 13 g of dextrose and about 34.5 g of amino acids
in about 242 mL of an aqueous composition; wherein if the body mass
of the subject is between 28 and 33 kg, the subject is parenterally
administered about 16 g of dextrose and about 42 g of amino acids
in about 283 mL of an aqueous composition; and wherein if the body
mass of the subject is between 34 and 39 kg, the subject is
parenterally administered about 20 g of dextrose and about 51 g of
amino acids in about 334 mL of an aqueous composition; thereby
treating or preventing malnutrition in the hemodialysis subject in
need thereof.
[0210] In another embodiment, the invention provides a method of
treating or preventing malnutrition in a hemodialysis subject in
need thereof comprising determining a body mass of the subject,
wherein if the body mass of the subject is between 9 and 12 kg, the
subject is parenterally administered about 6 g of dextrose and
about 13.5 g of amino acids in about 127 mL of an aqueous
composition; wherein if the body mass of the subject is between 13
and 17 kg, the subject is parenterally administered about 9 g of
dextrose and about 19.5 g of amino acids in about 160 mL of an
aqueous composition; wherein if the body mass of the subject is
between 18 and 22 kg, the subject is parenterally administered
about 12 g of dextrose and about 27 g of amino acids in about 202
mL of an aqueous composition; wherein if the body mass of the
subject is between 23 and 27 kg, the subject is parenterally
administered about 15.5 g of dextrose and about 34.5 g of amino
acids in about 245 mL of an aqueous composition; wherein if the
body mass of the subject is between 28 and 33 kg, the subject is
parenterally administered about 19 g of dextrose and about 42 g of
amino acids in about 287 mL of an aqueous composition; and wherein
if the body mass of the subject is between 34 and 39 kg, the
subject is parenterally administered about 23 g of dextrose and
about 51 g of amino acids in about 338 mL of an aqueous
composition; thereby treating or preventing malnutrition in the
hemodialysis subject in need thereof.
[0211] In another embodiment, the invention provides a method of
treating or preventing malnutrition in a hemodialysis subject in
need thereof comprising determining a body mass of the subject,
wherein if the body mass of the subject is between 9 and 12 kg, the
subject is parenterally administered about 4 g of dextrose and
about 13.5 g of amino acids in about 146 mL of an aqueous
composition; wherein if the body mass of the subject is between 13
and 17 kg, the subject is parenterally administered about 6 g of
dextrose and about 19.5 g of amino acids in about 189 mL of an
aqueous composition; wherein if the body mass of the subject is
between 18 and 22 kg, the subject is parenterally administered
about 9 g of dextrose and about 27 g of amino acids in about 243 mL
of an aqueous composition; wherein if the body mass of the subject
is between 23 and 27 kg, the subject is parenterally administered
about 11 g of dextrose and about 34.5 g of amino acids in about 296
mL of an aqueous composition; wherein if the body mass of the
subject is between 28 and 33 kg, the subject is parenterally
administered about 14 g of dextrose and about 42 g of amino acids
in about 350 mL of an aqueous composition; and wherein if the body
mass of the subject is between 34 and 39 kg, the subject is
parenterally administered about 17 g of dextrose and about 51 g of
amino acids in about 414 mL of an aqueous composition; thereby
treating or preventing malnutrition in the hemodialysis subject in
need thereof.
[0212] In another embodiment, the invention provides a method of
treating or preventing malnutrition in a hemodialysis subject in
need thereof comprising determining a body mass of the subject,
wherein if the body mass of the subject is between 9 and 12 kg, the
subject is parenterally administered about 5 g of dextrose and
about 13.5 g of amino acids in about 147 mL of an aqueous
composition; wherein if the body mass of the subject is between 13
and 17 kg, the subject is parenterally administered about 8 g of
dextrose and about 19.5 g of amino acids in about 191 mL of an
aqueous composition; wherein if the body mass of the subject is
between 18 and 22 kg, the subject is parenterally administered
about 10.5 g of dextrose and about 27 g of amino acids in about 243
mL of an aqueous composition; wherein if the body mass of the
subject is between 23 and 27 kg, the subject is parenterally
administered about 13 g of dextrose and about 34.5 g of amino acids
in about 299 mL of an aqueous composition; wherein if the body mass
of the subject is between 28 and 33 kg, the subject is parenterally
administered about 16 g of dextrose and about 42 g of amino acids
in about 353 mL of an aqueous composition; and wherein if the body
mass of the subject is between 34 and 39 kg, the subject is
parenterally administered about 20 g of dextrose and about 51 g of
amino acids in about 419 mL of an aqueous composition; thereby
treating or preventing malnutrition in the hemodialysis subject in
need thereof.
[0213] In another embodiment, the invention provides a method of
treating or preventing malnutrition in a hemodialysis subject in
need thereof comprising determining a body mass of the subject,
wherein if the body mass of the subject is between 9 and 12 kg, the
subject is parenterally administered about 6 g of dextrose and
about 13.5 g of amino acids in about 149 mL of an aqueous
composition; wherein if the body mass of the subject is between 13
and 17 kg, the subject is parenterally administered about 9 g of
dextrose and about 19.5 g of amino acids in about 193 mL of an
aqueous composition; wherein if the body mass of the subject is
between 18 and 22 kg, the subject is parenterally administered
about 12 g of dextrose and about 27 g of amino acids in about 247
mL of an aqueous composition; wherein if the body mass of the
subject is between 23 and 27 kg, the subject is parenterally
administered about 15.5 g of dextrose and about 34.5 g of amino
acids in about 302 mL of an aqueous composition; wherein if the
body mass of the subject is between 28 and 33 kg, the subject is
parenterally administered about 19 g of dextrose and about 42 g of
amino acids in about 357 mL of an aqueous composition; and wherein
if the body mass of the subject is between 34 and 39 kg, the
subject is parenterally administered about 23 g of dextrose and
about 51 g of amino acids in about 423 mL of an aqueous
composition; thereby treating or preventing malnutrition in the
hemodialysis subject in need thereof.
[0214] In another embodiment, the invention provides a method
useful for treating or preventing malnutrition in a hemodialysis
subject in need thereof comprising determining a body mass of the
subject, wherein if the body mass of the subject is between 34 and
39 kg, the subject is parenterally administered about 17 g of
dextrose and about 51 g of amino acids in about 329 mL of an
aqueous composition; wherein if the body mass of the subject is
between 40 and 44 kg, the subject is parenterally administered
about 20 g of dextrose and about 60 g of amino acids in about 379
mL of an aqueous composition; wherein if the body mass of the
subject is between 45 and 51 kg, the subject is parenterally
administered about 22 g of dextrose and about 68 g of amino acids
in about 421 mL of an aqueous composition; wherein if the body mass
of the subject is between 52 and 59 kg, the subject is parenterally
administered about 26 g of dextrose and about 78 g of amino acids
in about 477 mL of an aqueous composition; wherein if the body mass
of the subject is between 60 and 69 kg, the subject is parenterally
administered about 30 g of dextrose and about 90 g of amino acids
in about 543 mL of an aqueous composition; and wherein if the body
mass of the subject is 70 kg or higher, the subject is parenterally
administered about 35 g of dextrose and about 105 g of amino acids
in about 625 mL of an aqueous composition; thereby treating or
preventing malnutrition in the hemodialysis subject in need
thereof.
[0215] In another embodiment, the invention provides a method
useful for treating or preventing malnutrition in a hemodialysis
subject in need thereof comprising determining a body mass of the
subject, wherein if the body mass of the subject is between 34 and
39 kg, the subject is parenterally administered about 23 g of
dextrose and about 51 g of amino acids in about 338 mL of an
aqueous composition; wherein if the body mass of the subject is
between 40 and 44 kg, the subject is parenterally administered
about 27 g of dextrose and about 60 g of amino acids in about 389
mL of an aqueous composition; wherein if the body mass of the
subject is between 45 and 51 kg, the subject is parenterally
administered about 30 g of dextrose and about 68 g of amino acids
in about 433 mL of an aqueous composition; wherein if the body mass
of the subject is between 52 and 59 kg, the subject is parenterally
administered about 35 g of dextrose and about 78 g of amino acids
in about 490 mL of an aqueous composition; wherein if the body mass
of the subject is between 60 and 69 kg, the subject is parenterally
administered about 41 g of dextrose and about 90 g of amino acids
in about 559 mL of an aqueous composition; and wherein if the body
mass of the subject is 70 kg or higher, the subject is parenterally
administered about 47 g of dextrose and about 105 g of amino acids
in about 642 mL of an aqueous composition; thereby treating or
preventing malnutrition in the hemodialysis subject in need
thereof.
[0216] In another embodiment, the invention provides a method
useful for treating or preventing malnutrition in a hemodialysis
subject in need thereof comprising determining a body mass of the
subject, wherein if the body mass of the subject is between 34 and
39 kg, the subject is parenterally administered about 20 g of
dextrose and about 51 g of amino acids in about 334 mL of an
aqueous composition; wherein if the body mass of the subject is
between 40 and 44 kg, the subject is parenterally administered
about 23 g of dextrose and about 60 g of amino acids in about 383
mL of an aqueous composition; wherein if the body mass of the
subject is between 45 and 51 kg, the subject is parenterally
administered about 26 g of dextrose and about 68 g of amino acids
in about 427 mL of an aqueous composition; wherein if the body mass
of the subject is between 52 and 59 kg, the subject is parenterally
administered about 30 g of dextrose and about 78 g of amino acids
in about 483 mL of an aqueous composition; wherein if the body mass
of the subject is between 60 and 69 kg, the subject is parenterally
administered about 35 g of dextrose and about 90 g of amino acids
in about 550 mL of an aqueous composition; and wherein if the body
mass of the subject is 70 kg or higher, the subject is parenterally
administered about 41 g of dextrose and about 105 g of amino acids
in about 635 mL of an aqueous composition; thereby treating or
preventing malnutrition in the hemodialysis subject in need
thereof.
[0217] In another embodiment, the invention provides a method
useful for treating or preventing malnutrition in a hemodialysis
subject in need thereof comprising determining a body mass of the
subject, wherein if the body mass of the subject is between 34 and
39 kg, the subject is parenterally administered about 17 g of
dextrose and about 51 g of amino acids in about 414 mL of an
aqueous composition; wherein if the body mass of the subject is
between 40 and 44 kg, the subject is parenterally administered
about 20 g of dextrose and about 60 g of amino acids in about 479
mL of an aqueous composition; wherein if the body mass of the
subject is between 45 and 51 kg, the subject is parenterally
administered about 22 g of dextrose and about 68 g of amino acids
in about 536 mL of an aqueous composition; wherein if the body mass
of the subject is between 52 and 59 kg, the subject is parenterally
administered about 26 g of dextrose and about 78 g of amino acids
in about 607 mL of an aqueous composition; wherein if the body mass
of the subject is between 60 and 69 kg, the subject is parenterally
administered about 30 g of dextrose and about 90 g of amino acids
in about 693 mL of an aqueous composition; and wherein if the body
mass of the subject is 70 kg or higher, the subject is parenterally
administered about 35 g of dextrose and about 105 g of amino acids
in about 800 mL of an aqueous composition; thereby treating or
preventing malnutrition in the hemodialysis subject in need
thereof.
[0218] In another embodiment, the invention provides a method
useful for treating or preventing malnutrition in a hemodialysis
subject in need thereof comprising determining a body mass of the
subject, wherein if the body mass of the subject is between 34 and
39 kg, the subject is parenterally administered about 23 g of
dextrose and about 51 g of amino acids in about 423 mL of an
aqueous composition; wherein if the body mass of the subject is
between 40 and 44 kg, the subject is parenterally administered
about 27 g of dextrose and about 60 g of amino acids in about 489
mL of an aqueous composition; wherein if the body mass of the
subject is between 45 and 51 kg, the subject is parenterally
administered about 30 g of dextrose and about 68 g of amino acids
in about 548 mL of an aqueous composition; wherein if the body mass
of the subject is between 52 and 59 kg, the subject is parenterally
administered about 35 g of dextrose and about 78 g of amino acids
in about 620 mL of an aqueous composition; wherein if the body mass
of the subject is between 60 and 69 kg, the subject is parenterally
administered about 41 g of dextrose and about 90 g of amino acids
in about 709 mL of an aqueous composition; and wherein if the body
mass of the subject is 70 kg or higher, the subject is parenterally
administered about 47 g of dextrose and about 105 g of amino acids
in about 817 mL of an aqueous composition; thereby treating or
preventing malnutrition in the hemodialysis subject in need
thereof.
[0219] In another embodiment, the invention provides a method
useful for treating or preventing malnutrition in a hemodialysis
subject in need thereof comprising determining a body mass of the
subject, wherein if the body mass of the subject is between 34 and
39 kg, the subject is parenterally administered about 20 g of
dextrose and about 51 g of amino acids in about 419 mL of an
aqueous composition; wherein if the body mass of the subject is
between 40 and 44 kg, the subject is parenterally administered
about 23 g of dextrose and about 60 g of amino acids in about 483
mL of an aqueous composition; wherein if the body mass of the
subject is between 45 and 51 kg, the subject is parenterally
administered about 26 g of dextrose and about 68 g of amino acids
in about 542 mL of an aqueous composition; wherein if the body mass
of the subject is between 52 and 59 kg, the subject is parenterally
administered about 30 g of dextrose and about 78 g of amino acids
in about 613 mL of an aqueous composition; wherein if the body mass
of the subject is between 60 and 69 kg, the subject is parenterally
administered about 35 g of dextrose and about 90 g of amino acids
in about 700 mL of an aqueous composition; and wherein if the body
mass of the subject is 70 kg or higher, the subject is parenterally
administered about 41 g of dextrose and about 105 g of amino acids
in about 809 mL of an aqueous composition; thereby treating or
preventing malnutrition in the hemodialysis subject in need
thereof.
[0220] In another embodiment, the invention provides a method
useful for treating or preventing malnutrition in a hemodialysis
subject in need thereof comprising determining a body mass of the
subject, wherein if the body mass of the subject is between 34 and
39 kg, the subject is parenterally administered about 17 g of
dextrose, about 51 g of amino acids and about 8.6 g of lipids in
about 372 mL of an aqueous composition; wherein if the body mass of
the subject is between 40 and 44 kg, the subject is parenterally
administered about 20 g of dextrose, about 60 g of amino acids and
about 10.2 g of lipids in about 430 mL of an aqueous composition;
wherein if the body mass of the subject is between 45 and 51 kg,
the subject is parenterally administered about 22 g of dextrose,
about 68 g of amino acids and about 11.2 g of lipids in about 477
mL of an aqueous composition; wherein if the body mass of the
subject is between 52 and 59 kg, the subject is parenterally
administered about 26 g of dextrose, about 78 g of amino acids and
about 13.2 g of lipids in about 543 mL of an aqueous composition;
wherein if the body mass of the subject is between 60 and 69 kg,
the subject is parenterally administered about 30 g of dextrose,
about 90 g of amino acids and about 15.2 g of lipids in about 619
mL of an aqueous composition; and wherein if the body mass of the
subject is 70 kg or higher, the subject is parenterally
administered about 35 g of dextrose, about 105 g of amino acids and
about 17.8 g of lipids in about 715 mL of an aqueous composition;
thereby treating or preventing malnutrition in the hemodialysis
subject in need thereof.
[0221] In another embodiment, the invention provides a method
useful for treating or preventing malnutrition in a hemodialysis
subject in need thereof comprising determining a body mass of the
subject, wherein if the body mass of the subject is between 34 and
39 kg, the subject is parenterally administered about 23 g of
dextrose, about 51 g of amino acids and about 11.8 g of lipids in
about 397 mL of an aqueous composition; wherein if the body mass of
the subject is between 40 and 44 kg, the subject is parenterally
administered about 27 g of dextrose, about 60 g of amino acids and
about 13.8 g of lipids in about 458 mL of an aqueous composition;
wherein if the body mass of the subject is between 45 and 51 kg,
the subject is parenterally administered about 30 g of dextrose,
about 68 g of amino acids and about 15.2 g of lipids in about 509
mL of an aqueous composition; wherein if the body mass of the
subject is between 52 and 59 kg, the subject is parenterally
administered about 35 g of dextrose, about 78 g of amino acids and
about 17.8 g of lipids in about 579 mL of an aqueous composition;
wherein if the body mass of the subject is between 60 and 69 kg,
the subject is parenterally administered about 41 g of dextrose,
about 90 g of amino acids and about 21 g of lipids in about 664 mL
of an aqueous composition; and wherein if the body mass of the
subject is 70 kg or higher, the subject is parenterally
administered about 47 g of dextrose, about 105 g of amino acids and
about 24 g of lipids in about 762 mL of an aqueous composition;
thereby treating or preventing malnutrition in the hemodialysis
subject in need thereof.
[0222] In another embodiment, the invention provides a method
useful for treating or preventing malnutrition in a hemodialysis
subject in need thereof comprising determining a body mass of the
subject, wherein if the body mass of the subject is between 34 and
39 kg, the subject is parenterally administered about 20 g of
dextrose, about 51 g of amino acids and about 10.2 g of lipids in
about 385 mL of an aqueous composition; wherein if the body mass of
the subject is between 40 and 44 kg, the subject is parenterally
administered about 23 g of dextrose, about 60 g of amino acids and
about 11.8 g of lipids in about 442 mL of an aqueous composition;
wherein if the body mass of the subject is between 45 and 51 kg,
the subject is parenterally administered about 26 g of dextrose,
about 68 g of amino acids and about 13.3 g of lipids in about 493
mL of an aqueous composition; wherein if the body mass of the
subject is between 52 and 59 kg, the subject is parenterally
administered about 30 g of dextrose, about 78 g of amino acids and
about 15.2 g of lipids in about 559 mL of an aqueous composition;
wherein if the body mass of the subject is between 60 and 69 kg,
the subject is parenterally administered about 35 g of dextrose,
about 90 g of amino acids and about 17.8 g of lipids in about 639
mL of an aqueous composition; and wherein if the body mass of the
subject is 70 kg or higher, the subject is parenterally
administered about 41 g of dextrose, about 105 g of amino acids and
about 21 g of lipids in about 739 mL of an aqueous composition;
thereby treating or preventing malnutrition in the hemodialysis
subject in need thereof.
[0223] In another embodiment, the invention provides a method
useful for treating or preventing malnutrition in a hemodialysis
subject in need thereof comprising determining a body mass of the
subject, wherein if the body mass of the subject is between 34 and
39 kg, the subject is parenterally administered about 17 g of
dextrose, about 51 g of amino acids and about 8.6 g of lipids in
about 457 mL of an aqueous composition; wherein if the body mass of
the subject is between 40 and 44 kg, the subject is parenterally
administered about 20 g of dextrose, about 60 g of amino acids and
about 10.2 g of lipids in about 530 mL of an aqueous composition;
wherein if the body mass of the subject is between 45 and 51 kg,
the subject is parenterally administered about 22 g of dextrose,
about 68 g of amino acids and about 11.2 g of lipids in about 590
mL of an aqueous composition; wherein if the body mass of the
subject is between 52 and 59 kg, the subject is parenterally
administered about 26 g of dextrose, about 78 g of amino acids and
about 13.2 g of lipids in about 673 mL of an aqueous composition;
wherein if the body mass of the subject is between 60 and 69 kg,
the subject is parenterally administered about 30 g of dextrose,
about 90 g of amino acids and about 15.2 g of lipids in about 769
mL of an aqueous composition; and wherein if the body mass of the
subject is 70 kg or higher, the subject is parenterally
administered about 35 g of dextrose, about 105 g of amino acids and
about 17.8 g of lipids in about 889 mL of an aqueous composition;
thereby treating or preventing malnutrition in the hemodialysis
subject in need thereof.
[0224] In another embodiment, the invention provides a method
useful for treating or preventing malnutrition in a hemodialysis
subject in need thereof comprising determining a body mass of the
subject, wherein if the body mass of the subject is between 34 and
39 kg, the subject is parenterally administered about 23 g of
dextrose, about 51 g of amino acids and about 11.8 g of lipids in
about 482 mL of an aqueous composition; wherein if the body mass of
the subject is between 40 and 44 kg, the subject is parenterally
administered about 27 g of dextrose, about 60 g of amino acids and
about 13.8 g of lipids in about 558 mL of an aqueous composition;
wherein if the body mass of the subject is between 45 and 51 kg,
the subject is parenterally administered about 30 g of dextrose,
about 68 g of amino acids and about 15.2 g of lipids in about 622
mL of an aqueous composition; wherein if the body mass of the
subject is between 52 and 59 kg, the subject is parenterally
administered about 35 g of dextrose, about 78 g of amino acids and
about 17.8 g of lipids in about 709 mL of an aqueous composition;
wherein if the body mass of the subject is between 60 and 69 kg,
the subject is parenterally administered about 41 g of dextrose,
about 90 g of amino acids and about 21 g of lipids in about 814 mL
of an aqueous composition; and wherein if the body mass of the
subject is 70 kg or higher, the subject is parenterally
administered about 47 g of dextrose, about 105 g of amino acids and
about 24 g of lipids in about 937 mL of an aqueous composition;
thereby treating or preventing malnutrition in the hemodialysis
subject in need thereof.
[0225] In another embodiment, the invention provides a method
useful for treating or preventing malnutrition in a hemodialysis
subject in need thereof comprising determining a body mass of the
subject, wherein if the body mass of the subject is between 34 and
39 kg, the subject is parenterally administered about 20 g of
dextrose, about 51 g of amino acids and about 10.2 g of lipids in
about 470 mL of an aqueous composition; wherein if the body mass of
the subject is between 40 and 44 kg, the subject is parenterally
administered about 23 g of dextrose, about 60 g of amino acids and
about 11.8 g of lipids in about 542 mL of an aqueous composition;
wherein if the body mass of the subject is between 45 and 51 kg,
the subject is parenterally administered about 26 g of dextrose,
about 68 g of amino acids and about 13.2 g of lipids in about 606
mL of an aqueous composition; wherein if the body mass of the
subject is between 52 and 59 kg, the subject is parenterally
administered about 30 g of dextrose, about 78 g of amino acids and
about 15.2 g of lipids in about 689 mL of an aqueous composition;
wherein if the body mass of the subject is between 60 and 69 kg,
the subject is parenterally administered about 35 g of dextrose,
about 90 g of amino acids and about 17.8 g of lipids in about 789
mL of an aqueous composition; and wherein if the body mass of the
subject is 70 kg or higher, the subject is parenterally
administered about 41 g of dextrose, about 105 g of amino acids and
about 21 g of lipids in about 914 mL of an aqueous composition;
thereby treating or preventing malnutrition in the hemodialysis
subject in need thereof.
[0226] In one embodiment, a subject has adequate caloric intake. In
another embodiment, a subject has inadequate caloric intake. In
another embodiment, a subject has inadequate protein intake. In
another embodiment, a subject has adequate caloric intake and
inadequate protein intake. In another embodiment, a subject has
inadequate caloric intake and inadequate protein intake. In another
embodiment, a subject has normal body weight. In another
embodiment, a subject is overweight. In another embodiment, a
subject is obese. In another embodiment, a subject is underweight.
In another embodiment, a subject's ability to process fluids is
impaired. In another embodiment, a subject benefits from reduced
IDPN composition volume. In another embodiment, a subject is
administered an IDPN composition with reduced volume.
[0227] In one embodiment, the IDPN solution is formulated based on
the subject's body mass. In another embodiment, the subject's body
mass is estimated dry weight. Estimated dry weight describes the
mass of a subject prior to administration of an IDPN solution. In
another embodiment, the subject's body mass is the subjects ideal
body mass. Ideal body mass is determined based on the subject's
height. If a subject's actual body mass is greater than or equal to
115% of the subject's ideal body mass, then an IDPN solution can be
formulated based on the subject's ideal body mass. In the case of
an obese subject, an IDPN solution formulated based on the obese
subject's estimated dry weight or ideal body mass would lead to the
formulation of an IDPN solution with a volume and nutrition content
that are prohibitively high. The use of the ideal body mass, based
on height, provides a safer mechanism for determining the amount of
nutrition that the obese subject should receive.
[0228] In some embodiments, the invention provides a sterile
aqueous composition for parenteral administration comprising:
between 0.01 and 0.10 g/ml of dextrose; and between 0.07 and 0.20
g/ml of amino acids.
[0229] In some embodiments, the invention provides a sterile
aqueous composition for parenteral administration to a subject, the
composition comprising an amount of dextrose and an amount of amino
acids in a total volume, wherein: a) the amount of dextrose is
about 20 g, the amount of amino acids is about 51 g, and the total
volume is about 334 mL when the subject has a body mass of 34-39
kg; b) the amount of dextrose is about 23 g, the amount of amino
acids is about 60 g, and the total volume is about 383 mL when the
subject has a body mass of 40-44 kg; c) the amount of dextrose is
about 26 g, the amount of amino acids is about 68 g, and the total
volume is about 427 mL when the subject has a body mass of 45-51
kg; d) the amount of dextrose is about 30 g, the amount of amino
acids is about 78 g, and the total volume is about 483 mL when the
subject has a body mass of 52-59 kg; e) the amount of dextrose is
about 35 g, the amount of amino acids is about 90 g, and the total
volume is about 550 mL when the subject has a body mass of 60-69
kg; and f) the amount of dextrose is about 41 g, the amount of
amino acids is about 105 g, and the total volume is about 635 mL
when the subject has a body mass of at least 70 kg.
[0230] In some embodiments, the invention provides a sterile
aqueous composition for parenteral administration to a subject, the
composition comprising an amount of dextrose and an amount of amino
acids in a total volume, wherein: a) the amount of dextrose is
about 20 g, the amount of amino acids is about 51 g, and the total
volume is about 419 mL when the subject has a body mass of 34-39
kg; b) the amount of dextrose is about 23 g, the amount of amino
acids is about 60 g, and the total volume is about 483 mL when the
subject has a body mass of 40-44 kg; c) the amount of dextrose is
about 26 g, the amount of amino acids is about 68 g, and the total
volume is about 540 mL when the subject has a body mass of 45-51
kg; d) the amount of dextrose is about 30 g, the amount of amino
acids is about 78 g, and the total volume is about 613 mL when the
subject has a body mass of 52-59 kg; e) the amount of dextrose is
about 35 g, the amount of amino acids is about 90 g, and the total
volume is about 700 mL when the subject has a body mass of 60-69
kg; and f) the amount of dextrose is about 41 g, the amount of
amino acids is about 105 g, and the total volume is about 809 mL
when the subject has a body mass of at least 70 kg.
[0231] In some embodiments, the invention provides a sterile
aqueous composition for parenteral administration to a subject, the
composition comprising an amount of dextrose and an amount of amino
acids in a total volume, wherein: a) the amount of dextrose is
about 4 g, the amount of amino acids is about 13.5 g, and the total
volume is about 124 mL when the subject has a body mass of 9-12 kg;
b) the amount of dextrose is about 6 g, the amount of amino acids
is about 19.5 g, and the total volume is about 156 mL when the
subject has a body mass of 13-17 kg; c) the amount of dextrose is
about 9 g, the amount of amino acids is about 27 g, and the total
volume is about 198 mL when the subject has a body mass of 18-22
kg; d) the amount of dextrose is about 11 g, the amount of amino
acids is about 34.5 g, and the total volume is about 239 mL when
the subject has a body mass of 23-27 kg; e) the amount of dextrose
is about 14 g, the amount of amino acids is about 42 g, and the
total volume is about 280 mL when the subject has a body mass of
28-33 kg; and f) the amount of dextrose is about 17 g, the amount
of amino acids is about 51 g, and the total volume is about 329 mL
when the subject has a body mass of 34-39 kg.
[0232] In some embodiments, the invention provides a sterile
aqueous composition for parenteral administration to a subject, the
composition comprising an amount of dextrose and an amount of amino
acids in a total volume, wherein: a) the amount of dextrose is
about 5 g, the amount of amino acids is about 13.5 g, and the total
volume is about 125 mL when the subject has a body mass of 9-12 kg;
b) the amount of dextrose is about 8 g, the amount of amino acids
is about 19.5 g, and the total volume is about 158 mL when the
subject has a body mass of 13-17 kg; c) the amount of dextrose is
about 10.5 g, the amount of amino acids is about 27 g, and the
total volume is about 200 mL when the subject has a body mass of
18-22 kg; d) the amount of dextrose is about 13 g, the amount of
amino acids is about 34.5 g, and the total volume is about 242 mL
when the subject has a body mass of 23-27 kg; e) the amount of
dextrose is about 16 g, the amount of amino acids is about 42 g,
and the total volume is about 283 mL when the subject has a body
mass of 28-33 kg; and f) the amount of dextrose is about 20 g, the
amount of amino acids is about 51 g, and the total volume is about
334 mL when the subject has a body mass of 34-39 kg.
[0233] In some embodiments, the invention provides a sterile
aqueous composition for parenteral administration to a subject, the
composition comprising an amount of dextrose and an amount of amino
acids in a total volume, wherein: a) the amount of dextrose is
about 6 g, the amount of amino acids is about 13.5 g, and the total
volume is about 127 mL when the subject has a body mass of 9-12 kg;
b) the amount of dextrose is about 9 g, the amount of amino acids
is about 19.5 g, and the total volume is about 160 mL when the
subject has a body mass of 13-17 kg; c) the amount of dextrose is
about 12 g, the amount of amino acids is about 27 g, and the total
volume is about 202 mL when the subject has a body mass of 18-22
kg; d) the amount of dextrose is about 15.5 g, the amount of amino
acids is about 34.5 g, and the total volume is about 245 mL when
the subject has a body mass of 23-27 kg; e) the amount of dextrose
is about 19 g, the amount of amino acids is about 42 g, and the
total volume is about 287 mL when the subject has a body mass of
28-33 kg; and f) the amount of dextrose is about 23 g, the amount
of amino acids is about 51 g, and the total volume is about 338 mL
when the subject has a body mass of 34-39 kg.
[0234] In some embodiments, the invention provides a sterile
aqueous composition for parenteral administration to a subject, the
composition comprising an amount of dextrose and an amount of amino
acids in a total volume, wherein: a) the amount of dextrose is
about 4 g, the amount of amino acids is about 13.5 g, and the total
volume is about 146 mL when the subject has a body mass of 9-12 kg;
b) the amount of dextrose is about 6 g, the amount of amino acids
is about 19.5 g, and the total volume is about 189 mL when the
subject has a body mass of 13-17 kg; c) the amount of dextrose is
about 9 g, the amount of amino acids is about 27 g, and the total
volume is about 243 mL when the subject has a body mass of 18-22
kg; d) the amount of dextrose is about 11 g, the amount of amino
acids is about 34.5 g, and the total volume is about 296 mL when
the subject has a body mass of 23-27 kg; e) the amount of dextrose
is about 14 g, the amount of amino acids is about 42 g, and the
total volume is about 350 mL when the subject has a body mass of
28-33 kg; and f) the amount of dextrose is about 17 g, the amount
of amino acids is about 51 g, and the total volume is about 414 mL
when the subject has a body mass of 34-39 kg.
[0235] In some embodiments, the invention provides a sterile
aqueous composition for parenteral administration to a subject, the
composition comprising an amount of dextrose and an amount of amino
acids in a total volume, wherein: a) the amount of dextrose is
about 5 g, the amount of amino acids is about 13.5 g, and the total
volume is about 147 mL when the subject has a body mass of 9-12 kg;
b) the amount of dextrose is about 8 g, the amount of amino acids
is about 19.5 g, and the total volume is about 191 mL when the
subject has a body mass of 13-17 kg; c) the amount of dextrose is
about 10.5 g, the amount of amino acids is about 27 g, and the
total volume is about 245 mL when the subject has a body mass of
18-22 kg; d) the amount of dextrose is about 13 g, the amount of
amino acids is about 34.5 g, and the total volume is about 299 mL
when the subject has a body mass of 23-27 kg; e) the amount of
dextrose is about 16 g, the amount of amino acids is about 42 g,
and the total volume is about 353 mL when the subject has a body
mass of 28-33 kg; and f) the amount of dextrose is about 20 g, the
amount of amino acids is about 51 g, and the total volume is about
419 mL when the subject has a body mass of 34-39 kg.
[0236] In some embodiments, the invention provides a sterile
aqueous composition for parenteral administration to a subject, the
composition comprising an amount of dextrose and an amount of amino
acids in a total volume, wherein: a) the amount of dextrose is
about 6 g, the amount of amino acids is about 13.5 g, and the total
volume is about 149 mL when the subject has a body mass of 9-12 kg;
b) the amount of dextrose is about 9 g, the amount of amino acids
is about 19.5 g, and the total volume is about 193 mL when the
subject has a body mass of 13-17 kg; c) the amount of dextrose is
about 12 g, the amount of amino acids is about 27 g, and the total
volume is about 247 mL when the subject has a body mass of 18-22
kg; d) the amount of dextrose is about 15.5 g, the amount of amino
acids is about 34.5 g, and the total volume is about 302 mL when
the subject has a body mass of 23-27 kg; e) the amount of dextrose
is about 19 g, the amount of amino acids is about 42 g, and the
total volume is about 357 mL when the subject has a body mass of
28-33 kg; and f) the amount of dextrose is about 23 g, the amount
of amino acids is about 51 g, and the total volume is about 423 mL
when the subject has a body mass of 34-39 kg.
[0237] In some embodiments, the invention provides a sterile
aqueous composition for parenteral administration to a subject, the
composition comprising an amount of dextrose and an amount of amino
acids in a total volume, wherein: a) the amount of dextrose is
about 17 g, the amount of amino acids is about 51 g, and the total
volume is about 329 mL when the subject has a body mass of 34-39
kg; b) the amount of dextrose is about 20 g, the amount of amino
acids is about 60 g, and the total volume is about 379 mL when the
subject has a body mass of 40-44 kg; c) the amount of dextrose is
about 22 g, the amount of amino acids is about 68 g, and the total
volume is about 421 mL when the subject has a body mass of 45-51
kg; d) the amount of dextrose is about 26 g, the amount of amino
acids is about 78 g, and the total volume is about 477 mL when the
subject has a body mass of 52-59 kg; e) the amount of dextrose is
about 30 g, the amount of amino acids is about 90 g, and the total
volume is about 543 mL when the subject has a body mass of 60-69
kg; and f) the amount of dextrose is about 35 g, the amount of
amino acids is about 105 g, and the total volume is about 625 mL
when the subject has a body mass of at least 70 kg.
[0238] In some embodiments, the invention provides a sterile
aqueous composition for parenteral administration to a subject, the
composition comprising an amount of dextrose and an amount of amino
acids in a total volume, wherein: a) the amount of dextrose is
about 23 g, the amount of amino acids is about 51 g, and the total
volume is about 338 mL when the subject has a body mass of 34-39
kg; b) the amount of dextrose is about 27 g, the amount of amino
acids is about 60 g, and the total volume is about 389 mL when the
subject has a body mass of 40-44 kg; c) the amount of dextrose is
about 30 g, the amount of amino acids is about 68 g, and the total
volume is about 433 mL when the subject has a body mass of 45-51
kg; d) the amount of dextrose is about 35 g, the amount of amino
acids is about 78 g, and the total volume is about 490 mL when the
subject has a body mass of 52-59 kg; e) the amount of dextrose is
about 41 g, the amount of amino acids is about 90 g, and the total
volume is about 559 mL when the subject has a body mass of 60-69
kg; and f) the amount of dextrose is about 47 g, the amount of
amino acids is about 105 g, and the total volume is about 642 mL
when the subject has a body mass of at least 70 kg.
[0239] In some embodiments, the invention provides a sterile
aqueous composition for parenteral administration to a subject, the
composition comprising an amount of dextrose and an amount of amino
acids in a total volume, wherein: a) the amount of dextrose is
about 17 g, the amount of amino acids is about 51 g, and the total
volume is about 414 mL when the subject has a body mass of 34-39
kg; b) the amount of dextrose is about 20 g, the amount of amino
acids is about 60 g, and the total volume is about 479 mL when the
subject has a body mass of 40-44 kg; c) the amount of dextrose is
about 22 g, the amount of amino acids is about 68 g, and the total
volume is about 536 mL when the subject has a body mass of 45-51
kg; d) the amount of dextrose is about 26 g, the amount of amino
acids is about 78 g, and the total volume is about 607 mL when the
subject has a body mass of 52-59 kg; e) the amount of dextrose is
about 30 g, the amount of amino acids is about 90 g, and the total
volume is about 693 mL when the subject has a body mass of 60-69
kg; and f) the amount of dextrose is about 35 g, the amount of
amino acids is about 105 g, and the total volume is about 800 mL
when the subject has a body mass of at least 70 kg.
[0240] In some embodiments, the invention provides a sterile
aqueous composition for parenteral administration to a subject, the
composition comprising an amount of dextrose and an amount of amino
acids in a total volume, wherein: a) the amount of dextrose is
about 23 g, the amount of amino acids is about 51 g, and the total
volume is about 423 mL when the subject has a body mass of 34-39
kg; b) the amount of dextrose is about 27 g, the amount of amino
acids is about 60 g, and the total volume is about 489 mL when the
subject has a body mass of 40-44 kg; c) the amount of dextrose is
about 30 g, the amount of amino acids is about 68 g, and the total
volume is about 548 mL when the subject has a body mass of 45-51
kg; d) the amount of dextrose is about 35 g, the amount of amino
acids is about 78 g, and the total volume is about 620 mL when the
subject has a body mass of 52-59 kg; e) the amount of dextrose is
about 41 g, the amount of amino acids is about 90 g, and the total
volume is about 709 mL when the subject has a body mass of 60-69
kg; and f) the amount of dextrose is about 47 g, the amount of
amino acids is about 105 g, and the total volume is about 817 mL
when the subject has a body mass of at least 70 kg.
[0241] In some embodiments, the invention provides a sterile
aqueous composition for parenteral administration to a subject, the
composition comprising an amount of dextrose, an amount of amino
acids, and an amount of lipids in a total volume, wherein: a) the
amount of dextrose is about 17 g, the amount of amino acids is
about 51 g, the amount of lipids is about 8.6 g, and the total
volume is about 372 mL when the subject has a body mass of 34-39
kg; b) the amount of dextrose is about 20 g, the amount of amino
acids is about 60 g, the amount of lipids is about 10.2 g, and the
total volume is about 430 mL when the subject has a body mass of
40-44 kg; c) the amount of dextrose is about 22 g, the amount of
amino acids is about 68 g, the amount of lipids is about 11.2 g,
and the total volume is about 477 mL when the subject has a body
mass of 45-51 kg; d) the amount of dextrose is about 26 g, the
amount of amino acids is about 78 g, the amount of lipids is about
13.2 g, and the total volume is about 543 mL when the subject has a
body mass of 52-59 kg; e) the amount of dextrose is about 30 g, the
amount of amino acids is about 90 g, the amount of lipids is about
15.2 g, and the total volume is about 619 mL when the subject has a
body mass of 60-69 kg; and f) the amount of dextrose is about 35 g,
the amount of amino acids is about 105 g, the amount of lipids is
about 17.8 g, and the total volume is about 715 mL when the subject
has a body mass of at least 70 kg.
[0242] In some embodiments, the invention provides a sterile
aqueous composition for parenteral administration to a subject, the
composition comprising an amount of dextrose, an amount of amino
acids, and an amount of lipids in a total volume, wherein: a) the
amount of dextrose is about 23 g, the amount of amino acids is
about 51 g, the amount of lipids is about 11.8 g, and the total
volume is about 397 mL when the subject has a body mass of 34-39
kg; b) the amount of dextrose is about 27 g, the amount of amino
acids is about 60 g, the amount of lipids is about 13.8 g, and the
total volume is about 458 mL when the subject has a body mass of
40-44 kg; c) the amount of dextrose is about 30 g, the amount of
amino acids is about 68 g, the amount of lipids is about 15.2 g,
and the total volume is about 509 mL when the subject has a body
mass of 45-51 kg; d) the amount of dextrose is about 35 g, the
amount of amino acids is about 78 g, the amount of lipids is about
17.8 g, and the total volume is about 579 mL when the subject has a
body mass of 52-59 kg; e) the amount of dextrose is about 41 g, the
amount of amino acids is about 90 g, the amount of lipids is about
21 g, and the total volume is about 664 mL when the subject has a
body mass of 60-69 kg; and f) the amount of dextrose is about 47 g,
the amount of amino acids is about 105 g, the amount of lipids is
about 24 g, and the total volume is about 762 mL when the subject
has a body mass of at least 70 kg.
[0243] In some embodiments, the invention provides a sterile
aqueous composition for parenteral administration to a subject, the
composition comprising an amount of dextrose, an amount of amino
acids, and an amount of lipids in a total volume, wherein: a) the
amount of dextrose is about 20 g, the amount of amino acids is
about 51 g, the amount of lipids is about 10.2 g, and the total
volume is about 385 mL when the subject has a body mass of 34-39
kg; b) the amount of dextrose is about 23 g, the amount of amino
acids is about 60 g, the amount of lipids is about 11.8 g, and the
total volume is about 442 mL when the subject has a body mass of
40-44 kg; c) the amount of dextrose is about 26 g, the amount of
amino acids is about 68 g, the amount of lipids is about 13.3 g,
and the total volume is about 493 mL when the subject has a body
mass of 45-51 kg; d) the amount of dextrose is about 30 g, the
amount of amino acids is about 78 g, the amount of lipids is about
15.2 g, and the total volume is about 559 mL when the subject has a
body mass of 52-59 kg; e) the amount of dextrose is about 35 g, the
amount of amino acids is about 90 g, the amount of lipids is about
17.8 g, and the total volume is about 639 mL when the subject has a
body mass of 60-69 kg; and f) the amount of dextrose is about 41 g,
the amount of amino acids is about 105 g, the amount of lipids is
about 21 g, and the total volume is about 739 mL when the subject
has a body mass of at least 70 kg.
[0244] In some embodiments, the invention provides a sterile
aqueous composition for parenteral administration to a subject, the
composition comprising an amount of dextrose, an amount of amino
acids, and an amount of lipids in a total volume, wherein: a) the
amount of dextrose is about 17 g, the amount of amino acids is
about 51 g, the amount of lipids is about 8.6 g, and the total
volume is about 457 mL when the subject has a body mass of 34-39
kg; b) the amount of dextrose is about 20 g, the amount of amino
acids is about 60 g, the amount of lipids is about 10.2 g, and the
total volume is about 530 mL when the subject has a body mass of
40-44 kg; c) the amount of dextrose is about 22 g, the amount of
amino acids is about 68 g, the amount of lipids is about 11.2 g,
and the total volume is about 590 mL when the subject has a body
mass of 45-51 kg; d) the amount of dextrose is about 26 g, the
amount of amino acids is about 78 g, the amount of lipids is about
13.2 g, and the total volume is about 673 mL when the subject has a
body mass of 52-59 kg; e) the amount of dextrose is about 30 g, the
amount of amino acids is about 90 g, the amount of lipids is about
15.2 g, and the total volume is about 769 mL when the subject has a
body mass of 60-69 kg; and f) the amount of dextrose is about 35 g,
the amount of amino acids is about 105 g, the amount of lipids is
about 17.8 g, and the total volume is about 889 mL when the subject
has a body mass of at least 70 kg.
[0245] In some embodiments, the invention provides a sterile
aqueous composition for parenteral administration to a subject, the
composition comprising an amount of dextrose, an amount of amino
acids, and an amount of lipids in a total volume, wherein: a) the
amount of dextrose is about 23 g, the amount of amino acids is
about 51 g, the amount of lipids is about 11.8 g, and the total
volume is about 482 mL when the subject has a body mass of 34-39
kg; b) the amount of dextrose is about 27 g, the amount of amino
acids is about 60 g, the amount of lipids is about 13.8 g, and the
total volume is about 558 mL when the subject has a body mass of
40-44 kg; c) the amount of dextrose is about 30 g, the amount of
amino acids is about 68 g, the amount of lipids is about 15.2 g,
and the total volume is about 622 mL when the subject has a body
mass of 45-51 kg; d) the amount of dextrose is about 35 g, the
amount of amino acids is about 78 g, the amount of lipids is about
17.8 g, and the total volume is about 709 mL when the subject has a
body mass of 52-59 kg; e) the amount of dextrose is about 41 g, the
amount of amino acids is about 90 g, the amount of lipids is about
21 g, and the total volume is about 814 mL when the subject has a
body mass of 60-69 kg; and f) the amount of dextrose is about 47 g,
the amount of amino acids is about 105 g, the amount of lipids is
about 24 g, and the total volume is about 937 mL when the subject
has a body mass of at least 70 kg.
[0246] In some embodiments, the invention provides a sterile
aqueous composition for parenteral administration to a subject, the
composition comprising an amount of dextrose, an amount of amino
acids, and an amount of lipids in a total volume, wherein: a) the
amount of dextrose is about 20 g, the amount of amino acids is
about 51 g, the amount of lipids is about 10.2 g, and the total
volume is about 470 mL when the subject has a body mass of 34-39
kg; b) the amount of dextrose is about 23 g, the amount of amino
acids is about 60 g, the amount of lipids is about 11.8 g, and the
total volume is about 542 mL when the subject has a body mass of
40-44 kg; c) the amount of dextrose is about 26 g, the amount of
amino acids is about 68 g, the amount of lipids is about 13.2 g,
and the total volume is about 606 mL when the subject has a body
mass of 45-51 kg; d) the amount of dextrose is about 30 g, the
amount of amino acids is about 78 g, the amount of lipids is about
15.2 g, and the total volume is about 689 mL when the subject has a
body mass of 52-59 kg; e) the amount of dextrose is about 35 g, the
amount of amino acids is about 90 g, the amount of lipids is about
17.8 g, and the total volume is about 789 mL when the subject has a
body mass of 60-69 kg; and f) the amount of dextrose is about 41 g,
the amount of amino acids is about 105 g, the amount of lipids is
about 21 g, and the total volume is about 914 mL when the subject
has a body mass of at least 70 kg.
[0247] In one embodiment, the invention provides a method of
treating or preventing malnutrition in a pediatric subject, the
method comprising parenterally administering a sterile aqueous
composition to the subject, the composition comprising: an amount
of dextrose from about 4 g to about 19 g and an amount of amino
acids from about 13.5 g to about 42 g in a total volume of about
124 mL to about 357 mL, wherein the subject has a body mass of from
9 kg to 33 kg, wherein the administering is done at an infusion
rate of from 17 mL/hour to 127 mL/hour.
[0248] In another embodiment, the amount of dextrose is 4 g, the
amount of amino acids is 13.5 g, the total volume is 124 mL, and
the infusion rate is 23 mL/hour or 45 mL/hour when the subject has
a body mass of from 9 kg to 12 kg; the amount of dextrose is 6 g,
the amount of amino acids is 19.5 g, the total volume is 156 mL,
and the infusion rate is 28 mL/hour or 57 mL/hour when the subject
has a body mass of from 13 kg to 17 kg; the amount of dextrose is 9
g, the amount of amino acids is 27 g, the total volume is 198 mL,
and the infusion rate is 36 mL/hour or 72 mL/hour when the subject
has a body mass of from 18 kg to 22 kg; the amount of dextrose is
11 g, the amount of amino acids is 34.5 g, the total volume is 239
mL, and the infusion rate is 43 mL/hour or 87 mL/hour when the
subject has a body mass of from 23 kg to 27 kg; and the amount of
dextrose is 14 g, the amount of amino acids is 42 g, the total
volume is 280 mL, and the infusion rate is 51 mL/hour or 102
mL/hour when the subject has a body mass of from 28 kg to 33
kg.
[0249] In another embodiment, the amount of dextrose is 5 g, the
amount of amino acids is 13.5 g, the total volume is 125 mL, and
the infusion rate is 19 mL/hour or 39 mL/hour when the subject has
a body mass of from 9 kg to 12 kg; the amount of dextrose is 8 g,
the amount of amino acids is 19.5 g, the total volume is 158 mL,
and the infusion rate is 24 mL/hour or 49 mL/hour when the subject
has a body mass of from 13 kg to 17 kg; the amount of dextrose is
10.5 g, the amount of amino acids is 27 g, the total volume is 200
mL, and the infusion rate is 31 mL/hour or 62 mL/hour when the
subject has a body mass of from 18 kg to 22 kg; the amount of
dextrose is 13 g, the amount of amino acids is 34.5 g, the total
volume is 242 mL, and the infusion rate is 37 mL/hour or 74 mL/hour
when the subject has a body mass of from 23 kg to 27 kg; and the
amount of dextrose is 16 g, the amount of amino acids is 42 g, the
total volume is 283 mL, and the infusion rate is 44 mL/hour or 87
mL/hour when the subject has a body mass of from 28 kg to 33
kg.
[0250] In another embodiment, the amount of dextrose is 6 g, the
amount of amino acids is 13.5 g, the total volume is 127 mL, and
the infusion rate is 17 mL/hour or 34 mL/hour when the subject has
a body mass of from 9 kg to 12 kg; the amount of dextrose is 9 g,
the amount of amino acids is 19.5 g, the total volume is 160 mL,
and the infusion rate is 21 mL/hour or 43 mL/hour when the subject
has a body mass of from 13 kg to 17 kg; the amount of dextrose is
12 g, the amount of amino acids is 27 g, the total volume is 202
mL, and the infusion rate is 27 mL/hour or 54 mL/hour when the
subject has a body mass of from 18 kg to 22 kg; the amount of
dextrose is 15.5 g, the amount of amino acids is 34.5 g, the total
volume is 245 mL, and the infusion rate is 33 mL/hour or 65 mL/hour
when the subject has a body mass of from 23 kg to 27 kg; and the
amount of dextrose is 19 g, the amount of amino acids is 42 g, the
total volume is 287 mL, and the infusion rate is 38 mL/hour or 77
mL/hour when the subject has a body mass of from 28 kg to 33
kg.
[0251] In another embodiment, the amount of dextrose is 4 g, the
amount of amino acids is 13.5 g, the total volume is 146 mL, and
the infusion rate is 27 mL/hour or 53 mL/hour when the subject has
a body mass of from 9 kg to 12 kg; the amount of dextrose is 6 g,
the amount of amino acids is 19.5 g, the total volume is 189 mL,
and the infusion rate is 34 mL/hour or 69 mL/hour when the subject
has a body mass of from 13 kg to 17 kg; the amount of dextrose is 9
g, the amount of amino acids is 27 g, the total volume is 243 mL,
and the infusion rate is 44 mL/hour or 88 mL/hour when the subject
has a body mass of from 18 kg to 22 kg; the amount of dextrose is
11 g, the amount of amino acids is 34.5 g, the total volume is 296
mL, and the infusion rate is 54 mL/hour or 108 mL/hour when the
subject has a body mass of from 23 kg to 27 kg; and the amount of
dextrose is 14 g, the amount of amino acids is 42 g, the total
volume is 350 mL, and the infusion rate is 64 mL/hour or 127
mL/hour when the subject has a body mass of from 28 kg to 33
kg.
[0252] In another embodiment, the amount of dextrose is 5 g, the
amount of amino acids is 13.5 g, the total volume is 147 mL, and
the infusion rate is 23 mL/hour or 45 mL/hour when the subject has
a body mass of from 9 kg to 12 kg; the amount of dextrose is 8 g,
the amount of amino acids is 19.5 g, the total volume is 191 mL,
and the infusion rate is 29 mL/hour or 59 mL/hour when the subject
has a body mass of from 13 kg to 17 kg; the amount of dextrose is
10.5 g, the amount of amino acids is 27 g, the total volume is 245
mL, and the infusion rate is 38 mL/hour or 75 mL/hour when the
subject has a body mass of from 18 kg to 22 kg; the amount of
dextrose is 13 g, the amount of amino acids is 34.5 g, the total
volume is 299 mL, and the infusion rate is 46 mL/hour or 92 mL/hour
when the subject has a body mass of from 23 kg to 27 kg; and the
amount of dextrose is 16 g, the amount of amino acids is 42 g, the
total volume is 353 mL, and the infusion rate is 54 mL/hour or 109
mL/hour when the subject has a body mass of from 28 kg to 33
kg.
[0253] In another embodiment, the amount of dextrose is 6 g, the
amount of amino acids is 13.5 g, the total volume is 149 mL, and
the infusion rate is 20 mL/hour or 40 mL/hour when the subject has
a body mass of from 9 kg to 12 kg; the amount of dextrose is 9 g,
the amount of amino acids is 19.5 g, the total volume is 193 mL,
and the infusion rate is 26 mL/hour or 51 mL/hour when the subject
has a body mass of from 13 kg to 17 kg; the amount of dextrose is
12 g, the amount of amino acids is 27 g, the total volume is 247
mL, and the infusion rate is 33 mL/hour or 66 mL/hour when the
subject has a body mass of from 18 kg to 22 kg; the amount of
dextrose is 15.5 g, the amount of amino acids is 34.5 g, the total
volume is 302 mL, and the infusion rate is 40 mL/hour or 81 mL/hour
when the subject has a body mass of from 23 kg to 27 kg; and the
amount of dextrose is 19 g, the amount of amino acids is 42 g, the
total volume is 357 mL, and the infusion rate is 48 mL/hour or 95
mL/hour when the subject has a body mass of from 28 kg to 33
kg.
[0254] In one embodiment, the invention provides a method of
treating or preventing malnutrition in a subject, the method
comprising parenterally administering a sterile aqueous composition
to the subject, the composition comprising: an amount of dextrose
from about 17 g to about 47 g and an amount of amino acids from
about 51 g to about 105 g in a total volume of about 329 mL to
about 817 mL, wherein the subject has a body mass of from 34 kg to
at least 70 kg, wherein the administering is done at an infusion
rate of from 45 mL/hour to 290 mL/hour.
[0255] In another embodiment, the amount of dextrose is 17 g, the
amount of amino acids is 51 g, the total volume is 329 mL, and the
infusion rate is 60 mL/hour or 120 mL/hour when the subject has a
body mass of from 34 kg to 39 kg; the amount of dextrose is 20 g,
the amount of amino acids is 60 g, the total volume is 379 mL, and
the infusion rate is 70 mL/hour or 140 mL/hour when the subject has
a body mass of from 40 kg to 44 kg; the amount of dextrose is 22 g,
the amount of amino acids is 68 g, the total volume is 421 mL, and
the infusion rate is 80 mL/hour or 155 mL/hour when the subject has
a body mass of from 45 kg to 51 kg; the amount of dextrose is 26 g,
the amount of amino acids is 78 g, the total volume is 477 mL, and
the infusion rate is 90 mL/hour or 175 mL/hour when the subject has
a body mass of from 52 kg to 59 kg; the amount of dextrose is 30 g,
the amount of amino acids is 90 g, the total volume is 543 mL, and
the infusion rate is 100 mL/hour or 200 mL/hour when the subject
has a body mass of from 60 kg to 69 kg; and the amount of dextrose
is 35 g, the amount of amino acids is 105 g, the total volume is
625 mL, and the infusion rate is 115 mL/hour or 230 mL/hour when
the subject has a body mass of greater than 70 kg.
[0256] In another embodiment, the amount of dextrose is 23 g, the
amount of amino acids is 51 g, the total volume is 338 mL, and the
infusion rate is 45 mL/hour or 90 mL/hour when the subject has a
body mass of from 34 kg to 39 kg; the amount of dextrose is 27 g,
the amount of amino acids is 60 g, the total volume is 389 mL, and
the infusion rate is 55 mL/hour or 105 mL/hour when the subject has
a body mass of from 40 kg to 44 kg; the amount of dextrose is 30 g,
the amount of amino acids is 68 g, the total volume is 433 mL, and
the infusion rate is 60 mL/hour or 115 mL/hour when the subject has
a body mass of from 45 kg to 51 kg; the amount of dextrose is 35 g,
the amount of amino acids is 78 g, the total volume is 490 mL, and
the infusion rate is 65 mL/hour or 130 mL/hour when the subject has
a body mass of from 52 kg to 59 kg; the amount of dextrose is 41 g,
the amount of amino acids is 90 g, the total volume is 559 mL, and
the infusion rate is 75 mL/hour or 150 mL/hour when the subject has
a body mass of from 60 kg to 69 kg; and the amount of dextrose is
47 g, the amount of amino acids is 105 g, the total volume is 642
mL, and the infusion rate is 85 mL/hour or 175 mL/hour when the
subject has a body mass of greater than 70 kg.
[0257] In another embodiment, the amount of dextrose is 20 g, the
amount of amino acids is 51 g, the total volume is 334 mL, and the
infusion rate is 50 mL/hour or 105 mL/hour when the subject has a
body mass of from 34 kg to 39 kg; the amount of dextrose is 23 g,
the amount of amino acids is 60 g, the total volume is 383 mL, and
the infusion rate is 60 mL/hour or 120 mL/hour when the subject has
a body mass of from 40 kg to 44 kg; the amount of dextrose is 26 g,
the amount of amino acids is 68 g, the total volume is 427 mL, and
the infusion rate is 65 mL/hour or 135 mL/hour when the subject has
a body mass of from 45 kg to 51 kg; the amount of dextrose is 30 g,
the amount of amino acids is 78 g, the total volume is 483 mL, and
the infusion rate is 75 mL/hour or 150 mL/hour when the subject has
a body mass of from 52 kg to 59 kg; the amount of dextrose is 35 g,
the amount of amino acids is 90 g, the total volume is 550 mL, and
the infusion rate is 85 mL/hour or 170 mL/hour when the subject has
a body mass of from 60 kg to 69 kg; and the amount of dextrose is
41 g, the amount of amino acids is 105 g, the total volume is 635
mL, and the infusion rate is 100 mL/hour or 195 mL/hour when the
subject has a body mass of greater than 70 kg.
[0258] In another embodiment, the amount of dextrose is 17 g, the
amount of amino acids is 51 g, the total volume is 414 mL, and the
infusion rate is 75 mL/hour or 150 mL/hour when the subject has a
body mass of from 34 kg to 39 kg; the amount of dextrose is 20 g,
the amount of amino acids is 60 g, the total volume is 479 mL, and
the infusion rate is 90 mL/hour or 175 mL/hour when the subject has
a body mass of from 40 kg to 44 kg; the amount of dextrose is 22 g,
the amount of amino acids is 68 g, the total volume is 536 mL, and
the infusion rate is 100 mL/hour or 195 mL/hour when the subject
has a body mass of from 45 kg to 51 kg; the amount of dextrose is
26 g, the amount of amino acids is 78 g, the total volume is 607
mL, and the infusion rate is 110 mL/hour or 220 mL/hour when the
subject has a body mass of from 52 kg to 59 kg; the amount of
dextrose is 30 g, the amount of amino acids is 90 g, the total
volume is 693 mL, and the infusion rate is 130 mL/hour or 255
mL/hour when the subject has a body mass of from 60 kg to 69 kg;
and the amount of dextrose is 35 g, the amount of amino acids is
105 g, the total volume is 800 mL, and the infusion rate is 145
mL/hour or 290 mL/hour when the subject has a body mass of greater
than 70 kg.
[0259] In another embodiment the amount of dextrose is 23 g, the
amount of amino acids is 51 g, the total volume is 423 mL, and the
infusion rate is 60 mL/hour or 115 mL/hour when the subject has a
body mass of from 34 kg to 39 kg; the amount of dextrose is 27 g,
the amount of amino acids is 60 g, the total volume is 489 mL, and
the infusion rate is 65 mL/hour or 130 mL/hour when the subject has
a body mass of from 40 kg to 44 kg; the amount of dextrose is 30 g,
the amount of amino acids is 68 g, the total volume is 548 mL, and
the infusion rate is 75 mL/hour or 145 mL/hour when the subject has
a body mass of from 45 kg to 51 kg; the amount of dextrose is 35 g,
the amount of amino acids is 78 g, the total volume is 620 mL, and
the infusion rate is 85 mL/hour or 165 mL/hour when the subject has
a body mass of from 52 kg to 59 kg; the amount of dextrose is 41 g,
the amount of amino acids is 90 g, the total volume is 709 mL, and
the infusion rate is 95 mL/hour or 190 mL/hour when the subject has
a body mass of from 60 kg to 69 kg; and the amount of dextrose is
47 g, the amount of amino acids is 105 g, the total volume is 817
mL, and the infusion rate is 110 mL/hour or 220 mL/hour when the
subject has a body mass of greater than 70 kg.
[0260] In another embodiment, the amount of dextrose is 20 g, the
amount of amino acids is 51 g, the total volume is 419 mL, and the
infusion rate is 65 mL/hour or 130 mL/hour when the subject has a
body mass of from 34 kg to 39 kg; the amount of dextrose is 23 g,
the amount of amino acids is 60 g, the total volume is 483 mL, and
the infusion rate is 75 mL/hour or 150 mL/hour when the subject has
a body mass of from 40 kg to 44 kg; the amount of dextrose is 26 g,
the amount of amino acids is 68 g, the total volume is 542 mL, and
the infusion rate is 85 mL/hour or 170 mL/hour when the subject has
a body mass of from 45 kg to 51 kg; the amount of dextrose is 30 g,
the amount of amino acids is 78 g, the total volume is 613 mL, and
the infusion rate is 95 mL/hour or 190 mL/hour when the subject has
a body mass of from 52 kg to 59 kg; the amount of dextrose is 35 g,
the amount of amino acids is 90 g, the total volume is 700 mL, and
the infusion rate is 110 mL/hour or 215 mL/hour when the subject
has a body mass of from 60 kg to 69 kg; and the amount of dextrose
is 41 g, the amount of amino acids is 105 g, the total volume is
809 mL, and the infusion rate is 125 mL/hour or 250 mL/hour when
the subject has a body mass of greater than 70 kg.
[0261] In one embodiment, the invention provides a method of
treating or preventing malnutrition in a subject, the method
comprising parenterally administering a sterile aqueous composition
to the subject, the composition comprising: an amount of dextrose
from about 17 g to about 47 g, an amount of amino acids from about
51 g to about 105 g, and an amount of lipids from 8.6 g about to
about 24 in a total volume of about 372 mL to about 937 mL, wherein
the subject has a body mass of at least 34 kg, wherein the
administering is done at an infusion rate of from 45 mL/hour to 325
mL/hour.
[0262] In another embodiment, the amount of dextrose is 17 g, the
amount of amino acids is 51 g, the amount of lipids is 8.6 g, the
total volume is 372 mL, and the infusion rate is 60 mL/hour, 120
mL/hour, or 135 mL/hour when the subject has a body mass of from 34
kg to 39 kg; the amount of dextrose is 20 g, the amount of amino
acids is 60 g, the amount of lipids is 10.2 g, the total volume is
430 mL, and the infusion rate is 70 mL/hour, 140 mL/hour, or 160
mL/hour when the subject has a body mass of from 40 kg to 44 kg;
the amount of dextrose is 22 g, the amount of amino acids is 68 g,
the amount of lipids is 11.2 g, the total volume is 477 mL, and the
infusion rate is 80 mL/hour, 155 mL/hour, or 175 mL/hour when the
subject has a body mass of from 45 kg to 51 kg; the amount of
dextrose is 26 g, the amount of amino acids is 78 g, the amount of
lipids is 13.2 g, the total volume is 543 mL, and the infusion rate
is 90 mL/hour, 175 mL/hour, or 200 mL/hour when the subject has a
body mass of from 52 kg to 59 kg; the amount of dextrose is 30 g,
the amount of amino acids is 90 g, the amount of lipids is 15.2 g,
the total volume is 619 mL, and the infusion rate is 100 mL/hour,
200 mL/hour, or 225 mL/hour when the subject has a body mass of
from 60 kg to 69 kg; and the amount of dextrose is 35 g, the amount
of amino acids is 105 g, the amount of lipids is 17.8 g, the total
volume is 715 mL, and the infusion rate is 115 mL/hour, 230
mL/hour, or 260 mL/hour when the subject has a body mass of at
least 70 kg.
[0263] In another embodiment, the amount of dextrose is 23 g, the
amount of amino acids is 51 g, the amount of lipids is 11.8 g, the
total volume is 397 mL, and the infusion rate is 45 mL/hour, 90
mL/hour, or 110 mL/hour when the subject has a body mass of from 34
kg to 39 kg; the amount of dextrose is 27 g, the amount of amino
acids is 60 g, the amount of lipids is 13.8 g, the total volume is
458 mL, and the infusion rate is 55 mL/hour, 105 mL/hour, or 125
mL/hour when the subject has a body mass of from 40 kg to 44 kg;
the amount of dextrose is 30 g, the amount of amino acids is 68 g,
the amount of lipids is 15.2 g, the total volume is 509 mL, and the
infusion rate is 60 mL/hour, 115 mL/hour, or 135 mL/hour when the
subject has a body mass of from 45 kg to 51 kg; the amount of
dextrose is 35 g, the amount of amino acids is 78 g, the amount of
lipids is 17.8 g, the total volume is 579 mL, and the infusion rate
is 65 mL/hour, 130 mL/hour, or 155 mL/hour when the subject has a
body mass of from 52 kg to 59 kg; the amount of dextrose is 41 g,
the amount of amino acids is 90 g, the amount of lipids is 21 g,
the total volume is 664 mL, and the infusion rate is 75 mL/hour,
150 mL/hour, or 180 mL/hour when the subject has a body mass of
from 60 kg to 69 kg; and the amount of dextrose is 47 g, the amount
of amino acids is 105 g, the amount of lipids is 24 g, the total
volume is 762 mL, and the infusion rate is 85 mL/hour, 175 mL/hour,
or 205 mL/hour when the subject has a body mass of at least 70
kg.
[0264] In another embodiment, the amount of dextrose is 20 g, the
amount of amino acids is 51 g, the amount of lipids is 10.2 g, the
total volume is 385 mL, and the infusion rate is 55 mL/hour, 105
mL/hour, or 120 mL/hour when the subject has a body mass of from 34
kg to 39 kg; the amount of dextrose is 23 g, the amount of amino
acids is 60 g, the amount of lipids is 11.8 g, the total volume is
442 mL, and the infusion rate is 60 mL/hour, 120 mL/hour, or 140
mL/hour when the subject has a body mass of from 40 kg to 44 kg;
the amount of dextrose is 26 g, the amount of amino acids is 68 g,
the amount of lipids is 13.3 g, the total volume is 493 mL, and the
infusion rate is 65 mL/hour, 135 mL/hour, or 155 mL/hour when the
subject has a body mass of from 45 kg to 51 kg; the amount of
dextrose is 30 g, the amount of amino acids is 78 g, the amount of
lipids is 15.2 g, the total volume is 559 mL, and the infusion rate
is 75 mL/hour, 150 mL/hour, or 175 mL/hour when the subject has a
body mass of from 52 kg to 59 kg; the amount of dextrose is 35 g,
the amount of amino acids is 90 g, the amount of lipids is 17.8 g,
the total volume is 639 mL, and the infusion rate is 85 mL/hour,
170 mL/hour, or 200 mL/hour when the subject has a body mass of
from 60 kg to 69 kg; and the amount of dextrose is 41 g, the amount
of amino acids is 105 g, the amount of lipids is 21 g, the total
volume is 739 mL, and the infusion rate is 100 mL/hour, 195
mL/hour, or 230 mL/hour when the subject has a body mass of at
least 70 kg.
[0265] In another embodiment, the amount of dextrose is 17 g, the
amount of amino acids is 51 g, the amount of lipids is 8.6 g, the
total volume is 457 mL, and the infusion rate is 75 mL/hour, 150
mL/hour, or 170 mL/hour when the subject has a body mass of from 34
kg to 39 kg; the amount of dextrose is 20 g, the amount of amino
acids is 60 g, the amount of lipids is 10.2 g, the total volume is
530 mL, and the infusion rate is 90 mL/hour, 175 mL/hour, or 195
mL/hour when the subject has a body mass of from 40 kg to 44 kg;
the amount of dextrose is 22 g, the amount of amino acids is 68 g,
the amount of lipids is 11.2 g, the total volume is 590 mL, and the
infusion rate is 100 mL/hour, 195 mL/hour, or 215 mL/hour when the
subject has a body mass of from 45 kg to 51 kg; the amount of
dextrose is 26 g, the amount of amino acids is 78 g, the amount of
lipids is 13.2 g, the total volume is 673 mL, and the infusion rate
is 110 mL/hour, 220 mL/hour, or 245 mL/hour when the subject has a
body mass of from 52 kg to 59 kg; the amount of dextrose is 30 g,
the amount of amino acids is 90 g, the amount of lipids is 15.2 g,
the total volume is 769 mL, and the infusion rate is 130 mL/hour,
255 mL/hour, or 280 mL/hour when the subject has a body mass of
from 60 kg to 69 kg; and the amount of dextrose is 35 g, the amount
of amino acids is 105 g, the amount of lipids is 17.8 g, the total
volume is 889 mL, and the infusion rate is 145 mL/hour, 290
mL/hour, or 325 mL/hour when the subject has a body mass of at
least 70 kg.
[0266] In another embodiment, the amount of dextrose is 23 g, the
amount of amino acids is 51 g, the amount of lipids is 11.8 g, the
total volume is 482 mL, and the infusion rate is 60 mL/hour, 115
mL/hour, or 130 mL/hour when the subject has a body mass of from 34
kg to 39 kg; the amount of dextrose is 27 g, the amount of amino
acids is 60 g, the amount of lipids is 13.8 g, the total volume is
558 mL, and the infusion rate is 65 mL/hour, 130 mL/hour, or 150
mL/hour when the subject has a body mass of from 40 kg to 44 kg;
the amount of dextrose is 30 g, the amount of amino acids is 68 g,
the amount of lipids is 15.2 g, the total volume is 622 mL, and the
infusion rate is 75 mL/hour, 145 mL/hour, or 165 mL/hour when the
subject has a body mass of from 45 kg to 51 kg; the amount of
dextrose is 35 g, the amount of amino acids is 78 g, the amount of
lipids is 17.8 g, the total volume is 709 mL, and the infusion rate
is 85 mL/hour, 165 mL/hour, or 190 mL/hour when the subject has a
body mass of from 52 kg to 59 kg; the amount of dextrose is 41 g,
the amount of amino acids is 90 g, the amount of lipids is 21 g,
the total volume is 814 mL, and the infusion rate is 95 mL/hour,
190 mL/hour, or 220 mL/hour when the subject has a body mass of
from 60 kg to 69 kg; and the amount of dextrose is 47 g, the amount
of amino acids is 105 g, the amount of lipids is 24 g, the total
volume is 937 mL, and the infusion rate is 110 mL/hour, 220
mL/hour, or 250 mL/hour when the subject has a body mass of at
least 70 kg.
[0267] In another embodiment, the amount of dextrose is 20 g, the
amount of amino acids is 51 g, the amount of lipids is 10.2 g, the
total volume is 470 mL, and the infusion rate is 65 mL/hour, 130
mL/hour, or 145 mL/hour when the subject has a body mass of from 34
kg to 39 kg; the amount of dextrose is 23 g, the amount of amino
acids is 60 g, the amount of lipids is 11.8 g, the total volume is
542 mL, and the infusion rate is 75 mL/hour, 150 mL/hour, or 170
mL/hour when the subject has a body mass of from 40 kg to 44 kg;
the amount of dextrose is 26 g, the amount of amino acids is 68 g,
the amount of lipids is 13.2 g, the total volume is 606 mL, and the
infusion rate is 85 mL/hour, 170 mL/hour, or 190 mL/hour when the
subject has a body mass of from 45 kg to 51 kg; the amount of
dextrose is 30 g, the amount of amino acids is 78 g, the amount of
lipids is 15.2 g, the total volume is 689 mL, and the infusion rate
is 95 mL/hour, 190 mL/hour, or 215 mL/hour when the subject has a
body mass of from 52 kg to 59 kg; the amount of dextrose is 35 g,
the amount of amino acids is 90 g, the amount of lipids is 17.8 g,
the total volume is 789 mL, and the infusion rate is 110 mL/hour,
215 mL/hour, or 245 mL/hour when the subject has a body mass of
from 60 kg to 69 kg; and the amount of dextrose is 41 g, the amount
of amino acids is 105 g, the amount of lipids is 21 g, the total
volume is 914 mL, and the infusion rate is 125 mL/hour, 250
mL/hour, or 285 mL/hour when the subject has a body mass of at
least 70 kg.
[0268] In one embodiment, the invention provides a method for
treating or preventing malnutrition in a hemodialysis subject in
need thereof, wherein the subject does or does not have diabetes,
the method comprising formulating an aqueous composition comprising
between 1 and 10% mass/volume of dextrose, 7 to 20% mass/volume of
amino acids and less than 5% mass/volume of lipids based on a body
mass measurement of the subject and parenterally administering said
aqueous composition in conjunction with the hemodialysis.
[0269] In one embodiment, the invention provides a method for
treating or preventing malnutrition in a hemodialysis subject in
need thereof, the method comprising formulating an aqueous
composition comprising 7 to 20% mass/volume of amino acids based on
a body mass measurement of the subject and parenterally
administering said aqueous composition in conjunction with the
hemodialysis. In one embodiment, the invention provides a method
for treating or preventing malnutrition in a hemodialysis subject
in need thereof, the method comprising formulating a lipid-free
aqueous composition comprising 7 to 20% mass/volume of amino acids
based on a body mass measurement of the subject and parenterally
administering said aqueous composition in conjunction with the
hemodialysis. In one embodiment, the invention provides a method
for treating or preventing malnutrition in a hemodialysis subject
in need thereof, the method comprising formulating a
carbohydrate-free aqueous composition comprising 7 to 20%
mass/volume of amino acids based on a body mass measurement of the
subject and parenterally administering said aqueous composition in
conjunction with the hemodialysis. In one embodiment, the invention
provides a method for treating or preventing malnutrition in a
hemodialysis subject in need thereof, the method comprising
formulating a lipid- and carbohydrate-free aqueous composition
comprising 7 to 20% mass/volume of amino acids based on a body mass
measurement of the subject and parenterally administering said
aqueous composition in conjunction with the hemodialysis.
[0270] In one embodiment, the invention provides a method for
treating or preventing malnutrition in a hemodialysis subject in
need thereof, the method comprising formulating a lipid-free
aqueous composition comprising between 1 and 10% mass/volume of
dextrose, and 7 to 20% mass/volume of amino acids based on a body
mass measurement of the subject and parenterally administering said
aqueous composition in conjunction with the hemodialysis. In one
embodiment, the invention provides a method for treating or
preventing malnutrition in a hemodialysis subject in need thereof,
the method comprising formulating a lipid-free aqueous composition
comprising less than 0.1 g/mL of dextrose, and 7 to 20% mass/volume
of amino acids based on a body mass measurement of the subject and
parenterally administering said aqueous composition in conjunction
with the hemodialysis. In one embodiment, the invention provides a
method for treating or preventing malnutrition in a hemodialysis
subject in need thereof, the method comprising formulating an
aqueous composition comprising less than 0.1 mg/mL of dextrose, 7
to 20% mass/volume of amino acids, and less than 5% mass/volume of
lipids based on a body mass measurement of the subject and
parenterally administering said aqueous composition in conjunction
with the hemodialysis.
[0271] In one embodiment, the invention provides a method for
treating or preventing malnutrition in a hemodialysis subject in
need thereof, the method comprising formulating an aqueous
composition that is free of lipid, dextrose, fructose, sucrose,
lactose, galactose, mannose, maltose, ribose, arabinose, sorbose,
glyceraldehydes, or glycerol, comprising 7 to 20% mass/volume of
amino acids based on a body mass measurement of the subject and
parenterally administering said aqueous composition in conjunction
with the hemodialysis. In one embodiment, the invention provides a
method for treating or preventing malnutrition in a hemodialysis
subject in need thereof, the method comprising formulating an
aqueous composition comprising 7 to 20% mass/volume of amino acids
based on a body mass measurement of the subject and parenterally
administering said aqueous composition in conjunction with the
hemodialysis, wherein the composition is free of lipid, dextrose,
fructose, sucrose, lactose, galactose, mannose, maltose, ribose,
arabinose, sorbose, glyceraldehydes, or glycerol. In one
embodiment, the invention provides a method for treating or
preventing malnutrition in a hemodialysis subject in need thereof,
the method comprising formulating an aqueous composition that is
essentially free of lipid, dextrose, fructose, sucrose, lactose,
galactose, mannose, maltose, ribose, arabinose, sorbose,
glyceraldehydes, or glycerol, comprising 7 to 20% mass/volume of
amino acids based on a body mass measurement of the subject and
parenterally administering said aqueous composition in conjunction
with the hemodialysis. In one embodiment, the invention provides a
method for treating or preventing malnutrition in a hemodialysis
subject in need thereof, the method comprising formulating an
aqueous composition comprising 7 to 20% mass/volume of amino acids
based on a body mass measurement of the subject and parenterally
administering said aqueous composition in conjunction with the
hemodialysis, wherein the composition is essentially free of lipid,
dextrose, fructose, sucrose, lactose, galactose, mannose, maltose,
ribose, arabinose, sorbose, glyceraldehydes, or glycerol.
[0272] In one embodiment, the invention provides a method for
treating or preventing malnutrition in a hemodialysis subject in
need thereof, the method comprising formulating an aqueous
composition that is free of lipid, dextrose, fructose, sucrose,
lactose, galactose, mannose, maltose, ribose, arabinose, sorbose,
glyceraldehydes, and glycerol, comprising 7 to 20% mass/volume of
amino acids based on a body mass measurement of the subject and
parenterally administering said aqueous composition in conjunction
with the hemodialysis. In one embodiment, the invention provides a
method for treating or preventing malnutrition in a hemodialysis
subject in need thereof, the method comprising formulating an
aqueous composition comprising 7 to 20% mass/volume of amino acids
based on a body mass measurement of the subject and parenterally
administering said aqueous composition in conjunction with the
hemodialysis, wherein the composition is free of lipid, dextrose,
fructose, sucrose, lactose, galactose, mannose, maltose, ribose,
arabinose, sorbose, glyceraldehydes, and glycerol. In one
embodiment, the invention provides a method for treating or
preventing malnutrition in a hemodialysis subject in need thereof,
the method comprising formulating an aqueous composition that is
essentially free of lipid, dextrose, fructose, sucrose, lactose,
galactose, mannose, maltose, ribose, arabinose, sorbose,
glyceraldehydes, and glycerol, comprising 7 to 20% mass/volume of
amino acids based on a body mass measurement of the subject and
parenterally administering said aqueous composition in conjunction
with the hemodialysis. In one embodiment, the invention provides a
method for treating or preventing malnutrition in a hemodialysis
subject in need thereof, the method comprising formulating an
aqueous composition comprising 7 to 20% mass/volume of amino acids
based on a body mass measurement of the subject and parenterally
administering said aqueous composition in conjunction with the
hemodialysis, wherein the composition is essentially free of lipid,
dextrose, fructose, sucrose, lactose, galactose, mannose, maltose,
ribose, arabinose, sorbose, glyceraldehydes, and glycerol.
[0273] In one embodiment, the invention provides a method for
treating or preventing malnutrition in a hemodialysis subject in
need thereof, the method comprising formulating a lipid-free
aqueous composition comprising 7 to 20% mass/volume of amino acids
based on a body mass measurement of the subject and parenterally
administering said aqueous composition in conjunction with the
hemodialysis.
[0274] In one embodiment, the invention provides a method of
treating or preventing malnutrition in a pediatric hemodialysis
subject wherein the subject does or does not have diabetes, the
method comprising parenterally administering a sterile aqueous
composition to the subject, the composition comprising: an amount
of dextrose from about 4 g to about 19 g and an amount of amino
acids from about 13.5 g to about 42 g in a total volume of about
124 mL to about 357 mL, wherein the subject has a body mass of from
9 kg to 33 kg, wherein the administering is done at an infusion
rate of from 17 mL/hour to 127 mL/hour.
[0275] In one embodiment, the invention provides a method of
treating or preventing malnutrition in a hemodialysis subject
wherein the subject does or does not have diabetes, the method
comprising parenterally administering a sterile aqueous composition
to the subject, the composition comprising: an amount of dextrose
from about 17 g to about 47 g and an amount of amino acids from
about 51 g to about 105 g in a total volume of about 329 mL to
about 817 mL, wherein the subject has a body mass of from 34 kg to
at least 70 kg, wherein the administering is done at an infusion
rate of from 45 mL/hour to 290 mL/hour.
[0276] In one embodiment, the invention provides a A method of
treating or preventing malnutrition in a hemodialysis subject
wherein the subject does or does not have diabetes, the method
comprising parenterally administering a sterile aqueous composition
to the subject, the composition comprising: an amount of dextrose
from about 17 g to about 47 g, an amount of amino acids from about
51 g to about 105 g, and an amount of lipids from 8.6 g about to
about 24 in a total volume of about 372 mL to about 937 mL, wherein
the subject has a body mass of at least 34 kg, wherein the
administering is done at an infusion rate of from 45 mL/hour to 325
mL/hour.
[0277] Compositions and methods of the invention can be modified,
for example, by the age, size, or weight of the subject receiving
the composition. A composition of the invention can be modified,
for example, in any of: the amount of carbohydrate or amino acids
contained therein; the presence or amount of lipids contained
therein; the presence or amounts of micronutrients contained
therein; the presence or amounts of pharmaceutical agents contained
therein; the amount of fill; and the total volume. A method of the
invention can be modified, for example, in the rate of
administration of a composition, the frequency of administration,
or the formulation of the composition used.
EXAMPLES
[0278] The following IDPN compositions are non-limiting examples of
the extensive embodiments of the instant invention. In some
embodiments, a formula is administered to a subject for a specified
range of infusion times. In some embodiments, the formulas are fat
free and micronutrient free. These examples are representative, and
any IDPN composition contemplated herein can be used in the methods
of the examples.
Example 1
Administration of an IDPN Composition to a Subject
[0279] To a subject, currently undergoing dialysis and in need of
nutrition, is administered an IDPN composition according to FIG. 1,
via a dialysis machine using techniques known to a practitioner of
dialysis. The infusion rates during week one and week two of
administration are selected from the infusion rates according to
FIG. 2. The composition and the infusion rates are selected
according to the body mass of the subject.
Example 2
Administration of an IDPN Composition to a Subject
[0280] To a subject, currently undergoing dialysis and in need of
nutrition, is administered an IDPN composition according to FIG. 3,
via a dialysis machine using techniques known to a practitioner of
dialysis. The infusion rates during week one and week two of
administration are selected from the infusion rates according to
FIG. 4. The composition and the infusion rates are selected
according to the body mass of the subject.
Example 3
Administration of an IDPN Composition to a Subject
[0281] To a pediatric subject, currently undergoing dialysis and in
need of nutrition, is administered an IDPN composition according to
FIG. 5, via a dialysis machine using techniques known to a
practitioner of dialysis. The infusion rates during week one and
week two of administration are selected from the infusion rates
according to FIG. 6. The composition and the infusion rates are
selected according to the body mass of the subject.
Example 4
Administration of an IDPN Composition to a Subject
[0282] To a pediatric subject, currently undergoing dialysis and in
need of nutrition, is administered an IDPN composition according to
FIG. 7, via a dialysis machine using techniques known to a
practitioner of dialysis. The infusion rates during week one and
week two of administration are selected from the infusion rates
according to FIG. 8. The composition and the infusion rates are
selected according to the body mass of the subject.
Example 5
Administration of an IDPN Composition to a Subject
[0283] To a pediatric subject, currently undergoing dialysis and in
need of nutrition, is administered an IDPN composition according to
FIG. 9, via a dialysis machine using techniques known to a
practitioner of dialysis. The infusion rates during week one and
week two of administration are selected from the infusion rates
according to FIG. 10. The composition and the infusion rates are
selected according to the body mass of the subject.
Example 6
Administration of an IDPN Composition to a Subject
[0284] To a pediatric subject, currently undergoing dialysis and in
need of nutrition, is administered an IDPN composition according to
FIG. 11, via a dialysis machine using techniques known to a
practitioner of dialysis. The infusion rates during week one and
week two of administration are selected from the infusion rates
according to FIG. 12. The composition and the infusion rates are
selected according to the body mass of the subject.
Example 7
Administration of an IDPN Composition to a Subject
[0285] To a pediatric subject, currently undergoing dialysis and in
need of nutrition, is administered an IDPN composition according to
FIG. 13, via a dialysis machine using techniques known to a
practitioner of dialysis. The infusion rates during week one and
week two of administration are selected from the infusion rates
according to FIG. 14. The composition and the infusion rates are
selected according to the body mass of the subject.
Example 8
Administration of an IDPN Composition to a Subject
[0286] To a pediatric subject, currently undergoing dialysis and in
need of nutrition, is administered an IDPN composition according to
FIG. 15, via a dialysis machine using techniques known to a
practitioner of dialysis. The infusion rates during week one and
week two of administration are selected from the infusion rates
according to FIG. 16. The composition and the infusion rates are
selected according to the body mass of the subject.
Example 9
Administration of an IDPN Composition to a Subject
[0287] To a subject, currently undergoing dialysis and in need of
nutrition, is administered an IDPN composition according to FIG.
17, via a dialysis machine using techniques known to a practitioner
of dialysis. The infusion rates during week one and week two of
administration are selected from the infusion rates according to
FIG. 18. The composition and the infusion rates are selected
according to the body mass of the subject.
Example 10
Administration of an IDPN Composition to a Subject
[0288] To a subject, currently undergoing dialysis and in need of
nutrition, is administered an IDPN composition according to FIG.
19, via a dialysis machine using techniques known to a practitioner
of dialysis. The infusion rates during week one and week two of
administration are selected from the infusion rates according to
FIG. 20. The composition and the infusion rates are selected
according to the body mass of the subject.
Example 11
Administration of an IDPN Composition to a Subject
[0289] To a subject, currently undergoing dialysis and in need of
nutrition, is administered an IDPN composition according to FIG.
21, via a dialysis machine using techniques known to a practitioner
of dialysis. The infusion rates during week one and week two of
administration are selected from the infusion rates according to
FIG. 22. The composition and the infusion rates are selected
according to the body mass of the subject.
Example 12
Administration of an IDPN Composition to a Subject
[0290] To a subject, currently undergoing dialysis and in need of
nutrition, is administered an IDPN composition according to FIG.
23, via a dialysis machine using techniques known to a practitioner
of dialysis. The infusion rates during week one and week two of
administration are selected from the infusion rates according to
FIG. 24. The composition and the infusion rates are selected
according to the body mass of the subject.
Example 13
Administration of an IDPN Composition to a Subject
[0291] To a subject, currently undergoing dialysis and in need of
nutrition, is administered an IDPN composition according to FIG.
25, via a dialysis machine using techniques known to a practitioner
of dialysis. The infusion rates during week one and week two of
administration are selected from the infusion rates according to
FIG. 26. The composition and the infusion rates are selected
according to the body mass of the subject.
Example 14
Administration of an IDPN Composition to a Subject
[0292] To a subject, currently undergoing dialysis and in need of
nutrition, is administered an IDPN composition according to FIG.
27, via a dialysis machine using techniques known to a practitioner
of dialysis. The infusion rates during week one and week two of
administration are selected from the infusion rates according to
FIG. 28. The composition and the infusion rates are selected
according to the body mass of the subject.
Example 15
Administration of an IDPN Composition to a Subject
[0293] To a subject, currently undergoing dialysis and in need of
nutrition, is administered an IDPN composition according to FIG.
29, via a dialysis machine using techniques known to a practitioner
of dialysis. The infusion rates during week one, week two, and week
three of administration are selected from the infusion rates
according to FIG. 30. The composition and the infusion rates are
selected according to the body mass of the subject.
Example 16
Administration of an IDPN Composition to a Subject
[0294] To a subject, currently undergoing dialysis and in need of
nutrition, is administered an IDPN composition according to FIG.
31, via a dialysis machine using techniques known to a practitioner
of dialysis. The infusion rates during week one, week two, and week
three of administration are selected from the infusion rates
according to FIG. 32. The composition and the infusion rates are
selected according to the body mass of the subject.
Example 17
Administration of an IDPN Composition to a Subject
[0295] To a subject, currently undergoing dialysis and in need of
nutrition, is administered an IDPN composition according to FIG.
33, via a dialysis machine using techniques known to a practitioner
of dialysis. The infusion rates during week one, week two, and week
three of administration are selected from the infusion rates
according to FIG. 34. The composition and the infusion rates are
selected according to the body mass of the subject.
Example 18
Administration of an IDPN Composition to a Subject
[0296] To a subject, currently undergoing dialysis and in need of
nutrition, is administered an IDPN composition according to FIG.
35, via a dialysis machine using techniques known to a practitioner
of dialysis. The infusion rates during week one, week two, and week
three of administration are selected from the infusion rates
according to FIG. 36. The composition and the infusion rates are
selected according to the body mass of the subject.
Example 19
Administration of an IDPN Composition to a Subject
[0297] To a subject, currently undergoing dialysis and in need of
nutrition, is administered an IDPN composition according to FIG.
37, via a dialysis machine using techniques known to a practitioner
of dialysis. The infusion rates during week one, week two, and week
three of administration are selected from the infusion rates
according to FIG. 38. The composition and the infusion rates are
selected according to the body mass of the subject.
Example 20
Administration of an IDPN Composition to a Subject
[0298] To a subject, currently undergoing dialysis and in need of
nutrition, is administered an IDPN composition according to FIG.
39, via a dialysis machine using techniques known to a practitioner
of dialysis. The infusion rates during week one, week two, and week
three of administration are selected from the infusion rates
according to FIG. 40. The composition and the infusion rates are
selected according to the body mass of the subject.
Example 21
IDPN Composition and Regimen
[0299] The procedures described herein are a representative example
of IDPN therapy, and do not provide a strict protocol for the use,
administration, and monitoring of IDPN therapy.
[0300] An IDPN composition is selected using the subjects'
estimated dry weight (EDW), and the length of prescribed dialysis
treatment. Substrate utilization rates for carbohydrates and lipids
are considered within the context of the treatment time.
[0301] A composition is formulated with a concentrated stock
solution of 70% dextrose, an amino acid stock mixture 15% or 20% in
amino acids, optionally, and a lipid emulsion 20% or 30% in lipid.
The volume of the final composition is .ltoreq.1 liter. Subject
size or compromised cardiac status can necessitate longer dialysis
treatment times to allow greater infusion volumes and infusion
rates. Infusion volumes greater than 1 liter can be problematic in
subjects with compromised cardiac or respiratory status.
Optionally, the composition is formulated with additional vitamins,
minerals, and trace elements.
[0302] Half the volume of an IDPN composition lacking lipids is
infused at each administration during the first week. The full
volume of the composition, lacking lipids, is infused at each
administration during the second week of administration. Lipids, if
ordered as part of the regimen, are introduced during the third
week, and, if tolerated, are continued thereafter.
[0303] The progression of infusion volumes allows observation of
the subjects' physical tolerance to volume, observation of any
infusion reactions, metabolic tolerance by lab monitoring, and
blood pressure monitoring. Changes or additions to the IDPN
composition, dialysis, and/or medication regimens are made as
needed.
[0304] An IDPN composition is removed from the refrigerator at
least one hour prior to the infusion. An IDPN composition is warmed
to room temperature to prevent administration of a composition at
low temperature; bags are removed from the refrigerator up to about
12 hours prior to the infusion. The IDPN composition bag is
inspected for leaks or tears. The IDPN composition is inspected for
any particulate matter or oily separation. A bag is not used if the
bag is leaking or if particulate matter or separation is seen or
suspected. A bag containing an IDPN composition is stable at room
temperature for 24 hours. The label on the bag is inspected for the
subject's name and the expiration date of the composition. The
formulation listed on the bag is checked against the physician's
order to confirm that the correct prescription is being given.
Optionally, a multivitamin can be added to the IDPN bag itself or
administered through the injection port prior to administration.
The IDPN bag is hung and spiked with tubing that contains a 1.2
micron in-line filter. Alternatively, a separate 1.2 micron filter
is added to regular IV tubing and the bag is spiked with the same.
The tubing is primed for the type of pump being used for the
infusion. Air is purged from the filter if needed. The rate of
infusion is calculated to allow the infusion to complete 10 minutes
prior to the scheduled end of the dialysis treatment. Optionally,
time is allowed for the administration of other medications without
mixing of the medication and IDPN composition. IDPN infusion is
initiated through a port post dialyzer, such as the venous chamber,
after the subject has been established on the machine. Optionally,
insulin is added to the bag or is given subcutaneously, and the bag
is labeled appropriately.
[0305] A lab profile of the subject is obtained prior to the first
infusion. The subject's chart is checked for further orders
pertaining to the infusion of the IDPN. If this is the initial
infusion of IDPN, the subject is observed for allergic or adverse
reaction. The physician can order an increase or decrease in
infusion rate and/or infusion time at the beginning or end of the
infusion. A calculation of the IDPN composition volume into the
goal for fluid removal during each hemodialysis treatment is done
to avoid fluid overload. An attendee checks for insulin orders.
There is a possibility of fatty deposits occurring in the dialysis
catheter and causing an obstruction. Additional flushing of the
line with saline, e.g. 20 cc/lumen, is followed a heparin dose. The
subject eats or drinks a snack 30 minutes prior to the end of
treatment to prevent hypoglycemia. The snack should contain protein
and carbohydrate.
[0306] The volume of the IDPN composition to be infused is recorded
on the treatment flowsheet. The infusion rates are determined to
allow an optional 15 minute window of time for the higher end of
the dialysis time listed for each IDPN composition and no window
for the lower end of the dialysis time Ordered glucose levels
(drawn from the arterial line) and any insulin coverage listed are
recorded on the flowsheet or a specific monitoring sheet. The
volume infused is recorded. Subject response to the infusion, e.g.
cramping, low blood pressure, high blood pressure, shortness of
breath, itching, flushing, restlessness, vomiting, etc. are
recorded. The IDPN infusion is stopped if an allergic reaction is
suspected or the subject voices or displays unusual symptoms,
vomiting, or severe hypotension, and the physician is notified. A
dietitian is consulted for other issues of concern during the IDPN
infusion. An RN checks for insulin orders. Discussion with the
physician is advised for adjustments in formulation or
administration.
[0307] Lab chemistries are optional but recommended. If chemistries
are being monitored, then the phosphorus, potassium, and magnesium
levels are monitored closely during the first two weeks of IDPN
infusion.
[0308] Potassium levels are monitored during the first infusion of
each of weeks one and two. Data are collected both pre- and
post-infusion. A physician is notified if potassium levels reach
3.0 mEq/L. Potassium levels are adjusted if needed by one or more
of the following methods: adjust the K content of the bath; provide
additional oral potassium replacement; provide additional
potassium-containing salts to the dialysis bag; provide additional
potassium-containing salts intravenously separate from the dialysis
bag, such salts including potassium phosphate and potassium
acetate; and provide a snack with a high potassium content.
[0309] Phosphorous levels are monitored during the first infusion
of each of weeks one and two. Data are collected both pre- and
post-infusion. A physician is notified if phosphorous levels reach
2.0 mEq/L. Potassium levels are adjusted if needed by one or more
of the following methods: modify the amount of the phosphate
binder; provide oral phosphorus-containing medication; provide oral
phosphorus-containing medication; provide additional
phosphorus-containing salt replacements to the dialysis bag;
provide additional phosphorus-containing salt replacements
intravenously separate from the dialysis bag, such salts including
sodium phosphate or potassium phosphate; and provide a snack with a
high phosphorus content.
[0310] Magnesium levels are monitored during the first infusion of
each of weeks one and two. Data are collected both pre- and
post-infusion. A physician is notified if magnesium levels reach
1.5 mEq/L. Magnesium levels are adjusted if needed by one or more
of the following methods: provide magnesium-containing compounds
orally, provide a magnesium replacement to the dialysis bag, or
provide a magnesium replacement via dialysis separate form the
dialysis bag.
[0311] Baseline composite chemistries are obtained prior to the
initiation of IDPN. Lab work for potassium, phosphorus, and
magnesium is obtained as frequently as needed until deemed stable.
Results of lab work are recorded, and a physician is consulted as
to any changes in administration. Written orders are obtained for
any medication changes/prescriptions. Written orders for any
desired IDPN composition changes are obtained.
[0312] An IV lipid test dose is performed on the first treatment of
the third week. Triglyceride levels are monitored prior to the
first infusion of the third week. A physician is notified if
triglyceride levels reach .gtoreq.300 mEq/L or >50% baseline. If
lipid levels must be lowered in a subject, the following procedure
can be employed.
[0313] The subject's rate of caloric consumption is determined The
subject's lipid profile is determined and medication is prescribed
as needed. The lipid levels in the IDPN composition are decreased
to 0.15 gm/kg/hr. The subject's serum carnitine level is optionally
determined. An intravenous lipid test dose infusion is performed.
Observations are made for signs of intolerance, for example,
wheezing, nausea, dyspnea, flushing, hypotension, cyanosis,
vomiting, chest or back pain, sweating, local site irritation,
pressure over the eyes, headache, or elevated temperature. Wheezing
and hypotension can indicate allergic reaction. If wheezing and
hypotension are observed, the infusion is stopped and the physician
is notified. If the test infusion is tolerated, the rate of
infusion is escalated to the desired final rate of infusion.
Triglyceride levels are recorded on the IDPN flowsheet. A physician
is consulted for orders or changes in the solution composition.
[0314] Blood glucose levels for every administration (drawn from
the arterial line) are obtained pre-infusion, 1-hour into infusion,
and post infusion. Sliding scale coverage can be used; however,
insulin regimens are advised.
[0315] Glucose levels in a subject are modulated if needed by the
following method. Baseline blood sugar is determined using a sample
from the arterial line and a glucose monitor. 1-hour and post blood
sugar readings are taken for the first two weeks of therapy. The
subject is monitored for signs of hyperglycemia, e.g. headache,
nausea, thirst, flushing, weakness, and rapid respirations. Regular
insulin coverage might be needed. Blood sugar coverage on a sliding
scale can begin at blood sugar readings of greater than 150 mg/dL
or greater than 200 mg/dL, but a physician is called for blood
sugars readings greater than 350 mg/dL Coverage orders are obtained
when indicated for blood sugars greater than 350 mg/dL. Adjustment
of the subject to the regimen can often correct the hyperglycemia
without necessitating coverage. Insulin is checked hourly and
glucose every 30 minutes. The blood sugar can drop after the IDPN
infusion is discontinued. Subjects that are most susceptible
include non-diabetic subjects, subjects receiving insulin coverage
at the 1-hour mark, subjects receiving split dose insulin (NPH)
that peaks during or near the cessation of the IDPN infusion. The
subject might need to remain in the unit until stable, and is
monitored for symptoms of hypoglycemia, e.g. headache, diplopia,
dizziness, nervousness, cold sweat, nausea, and hunger.
Hypoglycemia is treated with 2 teaspoons of sugar in a glass of
fruit juice. Subjects eat or drink a snack about 30 minutes before
the end of the IDPN infusion. The snack contains a source of
protein and carbohydrate, for example, half of a meat sandwich or
appropriate oral supplement. Blood glucose levels are recorded on
the dialysis flowsheet.
[0316] Monthly chemistries to be monitored include dialyzer
clearance rate, urea reduction ratio (URR), liver function of
aminotransferases (LFT), and bicarbonate levels.
[0317] Dialyzer clearance rate is defined as Kt/V, wherein: K=mL
blood/min through a dialysis machine; t=time; and V=volume. A
physician is notified if a subject's rate falls below 1.2, and/or
the subject's URR falls below 65%. Increased protein provision can
decrease the dialyzer clearance rate.
[0318] LFT describes the activity of alanine aminotransferase (ALT)
and aspartate aminotransferase (AST) in the liver. A physician is
notified if a subject's LFT elevates 2.times. above the baseline
value.
[0319] A physician is also notified if a subject's bicarbonate
levels fall below 22 mmol/L. K/DOQI Nutrition Guidelines advise
serum HCO.sub.3 levels be at 22 mmol/L. The replacement of
bicarbonate is at the clinician's discretion.
[0320] Possible actions for these events include increase in
treatment time; decrease in lipid or carbohydrate amounts with
monitoring; oral repletion of bicarbonate; and additional acetate
in the IDPN composition. Subjects exhibiting hypertension,
congestive heart failure, or edema often benefit from oral
repletion of calcium carbonate as an alternative to sodium
carbonate or sodium acetate. An increase in treatment time
necessitates reformulation of the IDPN solution.
Physical Monitoring
TABLE-US-00006 [0321] SYMPTOM POSSIBLE CAUSE POSSIBLE CORRECTIVE
ACTION Cramping "Cold Shock" Remove IDPN from refrigerator 12 hours
before infusion. Deficiency State: Potassium Check serum level;
consider oral repletion if GI status permits Calcium Correct
calcium deficit Magnesium Correct magnesium deficit Carnitine
Obtain Carnitine level and provide IV carnitine as needed
Hypotension Volume Deficit Check calculation of UF goal; evaluate
EDW; give additional NS as volume replacement Sodium Deficit Add
sodium salt to the IDPN solution Shortness Excess Volume Consider
total volume and decrease of Breath if indicated Rate too Rapid
Reduce rate of infusion Low Phosphorus Check level; Replete if
indicated Excess IV lipid Do not exceed 4 mg/kg/min or 12.5 g/hr of
IV lipid Generalized Mg Deficiency Increase Magnesium in IDPN
Muscle Carnitine Obtain serum level; replete with oral Weakness or
Deficiency or IV Rx as indicated Tenderness Selenium Obtain serum
level; replete IV Deficiency sodium Selenemite as indicated
[0322] A dietitian performs monthly nutritional assessments using
Albumin, normalized protein catabolic rate (nPCR), and EDW, EDW
changes, and anthropometric data. Assessment of subject tolerance,
physical and metabolic, is rendered and assessment of current IDPN
solution is reviewed. The dietitian confers with the physician for
any recommended solution changes and obtains IDPN orders as
indicated. The dietitian obtains the physician signature on any new
IDPN orders, forwards to the IDPN provider, and continues to
monitor monthly progress.
Example 22
Epidemiological Study on IDPN Composition Infusions in Diabetic
Subjects
[0323] Collected data were analyzed to evaluate the efficacy of
low-volume, low-carbohydrate IDPN compositions that lacked lipids
versus the efficacy of lipid-containing IDPN compositions with
higher volumes and higher carbohydrate amounts. All compositions
contained amino acids. Subject groups included: a) 41 diabetic
adult subjects who had received high-volume IDPN compositions
containing amino acids, lipids, and carbohydrates, for at least 3
consecutive months (Group I); and b) 63 diabetic adult subjects who
had received low-volume IDPN compositions containing amino acids,
no lipids and a lesser amount of carbohydrates than the
compositions of Group I, for at least 3 consecutive months (Group
II). Baseline serum data were collected for all subjects in both
groups. All subjects received hemodialysis by the same method of
administration three times a week, uninterrupted over the course of
therapy, with infusion times in the range of 3.25-3.50 hours. An
individual subject received the same IDPN composition for the
duration of the therapy. An analysis was performed comparing the
baseline and 3 month serum albumin levels of both groups.
[0324] Among Group I diabetic subjects the baseline mean serum
albumin was 2.93.+-.0.47 g/dL and the 3 month mean serum albumin
was 3.10.+-.0.52 g/dL. Among Group II diabetic subjects, the mean
baseline serum albumin was 2.86.+-.0.49 g/dL and the 3 month mean
serum albumin was 3.18.+-.0.33 g/dL. The mean increase in serum
albumin among Group I subjects was 0.18.+-.0.37 g/dL and the mean
serum increase among Group II subjects was 0.31.+-.0.48 g/dL. FIG.
37 provides a graph of these data; in FIG. 37: A) describes Group I
subjects' baseline mean levels; B) describes Group I subjects' 3
month mean levels; C) describes Group II subjects' baseline mean
levels; and D) describes Group II subjects' 3 month mean levels.
The y-axis describes serum albumin levels in g/L. A two sample
t-test was performed on this data and a P value of 0.059 was
calculated. Group II subjects, receiving the low-volume,
low-carbohydrate, lipid-free IDPN composition, exhibited a greater
serum albumin change in 3 months than did the subjects of group I,
at a level approaching statistical significance. Not all subjects
of either group responded to the therapy, and in a minority of
cases, a subject exhibited depressed albumin levels at 3
months.
Example 23
Epidemiological Study on IDPN Composition Infusions in Non-Diabetic
Subjects
[0325] Collected data were analyzed to evaluate the efficacy of
low-volume, low-carbohydrate IDPN compositions that lacked lipids
versus the efficacy of lipid-containing IDPN compositions with
higher volume and higher carbohydrate amounts. All compositions
contained amino acids. Subject groups included: a) 42 non-diabetic
adult subjects who had received the same high-volume IDPN
composition, containing amino acids, lipids and carbohydrates, for
at least 3 consecutive months (Group I); and b) 29 non-diabetic
adult subjects who had received the same low volume IDPN
composition, containing amino acids, no lipids and half the
carbohydrates of the composition of Group I, for at least 3
consecutive months (Group II). Baseline serum data was collected
for all subjects in both groups. All subjects received hemodialysis
by the same method of administration three times a week,
uninterrupted over the course of therapy, with infusion times in
the range of 3.25-3.50 hours. Each individual subject received the
same IDPN composition for the duration of the therapy. An analysis
was performed comparing the baseline and 3 month serum albumin
levels of both groups.
[0326] Among Group I non-diabetic subjects, the mean baseline serum
albumin was 2.97.+-.0.55 g/dL and the 3 month mean serum albumin
was 3.33.+-.0.56 g/dL. Among Group II non-diabetic subjects, the
mean baseline serum albumin was 2.84.+-.0.45 g/dL and the 3 month
mean serum albumin was 3.16.+-.0.49 g/dL. The mean increase in
serum albumin among Group I subjects was 0.36.+-.0.43 g/dL and the
mean increase in serum albumin among Group II subjects was
0.31.+-.0.75 g/dL. FIG. 38 provides a graph of these data; in FIG.
38: A) describes Group I subjects' baseline mean levels; B)
describes Group I subjects' 3 month mean levels; C) describes Group
II subjects' baseline mean levels; and D) describes Group II
subjects' 3 month mean levels. The y-axis describes serum albumin
levels in g/L. A two sample t-test was performed on this data and a
P value of 0.35 was calculated, indicating that the results were
consistent form Group I to Group II. Not all subjects responded to
the therapy, and in a minority of cases, a subject exhibited
depressed albumin levels at 3 months.
Example 24
Epidemiological Study on IDPN Composition Infusions in Subjects
Representing Statistical Outliers
[0327] The data from all subjects from Group I or Group II from
either Example 22 or Example 23 that experienced an increase in
serum albumin levels of greater than 1.0 g/dL were examined for
statistical significance. Among Group I subjects (n=2), the mean
baseline serum albumin was 2.70.+-.0.14 g/dL and the three month
mean serum albumin was 4.10.+-.0.14 g/dL. Analysis by t-test
comparing the baseline mean to the three month mean provided a P
value of 0.090. Among Group II subjects (n=10), the baseline mean
was 2.06.+-.0.47 g/dL and the three month mean was 3.44.+-.0.34
g/dL. Analysis by t-test comparing the baseline to the three month
mean provided a P value of <0.005. In comparing the increase in
serum albumin levels of both groups, Group I exhibited a mean
increase of 1.40.+-.0.28 g/dL, and Group II exhibited a mean
increase of 1.32.+-.0.29 g/dL. Analysis by t-test of the increase
in serum albumin levels between the two groups provided a P value
of 0.762. The lack of statistical significance in these results is
owed to the small n value of the subject set. The increases in
albumin levels were consistent from Group Ito Group II.
Example 25
Epidemiological Study on the Effects on Fluid Removal of IDPN
Composition Infusions
[0328] Collected data were analyzed to evaluate the efficacy of a
high-volume IDPN composition containing amino acids, lipids, and
carbohydrates (Group I) versus the efficacy of a low-volume IDPN
composition containing amino acids, no lipids and a lower amount of
carbohydrates than the compositions of Group I (Group II). Seven
patients in Group I had mean fluid removal goals of 1.59 L, while
the mean actual fluid removal was 1.60 L, resulting in a difference
of 0.01 L. Amongst 13 patients in Group II, the mean fluid removal
goal was 2.85 L, while the mean actual fluid removal was 3.00 L,
which represents a difference of 0.15 L.
Example 26
Epidemiological Study on the Effects on Blood Glucose of IDPN
Composition Infusions
[0329] Collected data were analyzed to evaluate the efficacy of a
high-volume IDPN composition containing amino acids, lipids, and
carbohydrates (Group I) versus the efficacy of a low-volume IDPN
composition containing amino acids, no lipids and a lower amount of
carbohydrates than the compositions of Group I (Group II). Over 12
treatments, one patient in Group I had mean pre-infusion blood
glucose level of 221.83 mg/dL, a mean 1-hour blood glucose level of
317.5 mg/dL, and a mean post-infusion blood glucose level of 242.08
mg/dL. The patient was administered with a mean of 3 u of insulin
pre-infusion, and a mean of 7.58 u of insulin mid-infusion. Over 12
treatments, one patient in Group II had a mean pre-infusion blood
glucose level of 208.83 mg/dL, a mean 1-hour blood glucose level of
212.25 mg/dL, and a mean post-infusion blood glucose of 178.42
mg/dL. This patient was not administered with insulin pre-, or
mid-infusion.
Example 27
Preparation of an IDPN Solution
[0330] To 340 mL aliquot of the amino acid stock mixture of Table
II (15 g of amino acids per 100 mL) is added 33 mL of an aqueous
dextrose stock solution (70 g dextrose per 100 mL). The total
volume is diluted to 423 mL with an appropriate volume of fill
(approximately 50 mL) to provide an IDPN composition containing 51
g of amino acids and 23 g of dextrose in a 423 mL solution (0.12
g/mL amino acids and 0.054 g/mL dextrose).
Example 28
Preparation of an IDPN Solution
[0331] To 340 mL aliquot of the amino acid stock mixture of Table
II (15 g of amino acids per 100 mL) is added 33 mL of an aqueous
dextrose stock solution (70 g dextrose per 100 mL) and 59 mL of a
lipid stock mixture (20 g lipids per 100 mL). The total volume is
diluted to 482 mL with an appropriate volume of fill (approximately
50 mL) to provide an IDPN composition containing 51 g of amino
acids, 23 g of dextrose, and 11.8 g of lipids in a 482 mL solution
(0.11 g/mL amino acids, 0.048 g/mL dextrose, and 0.024 g/mL
lipids).
Example 29
Epidemiological Study on IDPN Composition Infusions
[0332] Collected data were analyzed to evaluate the efficacy of
low-volume, low-carbohydrate IDPN compositions that lacked lipids
versus the efficacy of lipid-containing IDPN compositions with
high-volume and high-carbohydrate amounts. All compositions
contained amino acids. The low-volume compositions had a volume of
about 37% of that of the corresponding high-volume compositions.
High volume compositions contained 4-6 mg of carbohydrate per kg of
subject body mass for subjects requiring carbohydrate control; 6-8
mg of carbohydrate per kg of subject body mass for subjects not
requiring carbohydrate control; and lipids administered at the
lower of 4 mg lipids per kg subject body mass per minute, or 12
g/hr. The amount of carbohydrates administered to an individual
subject was related to the body mass of the individual subject, and
the composition administered to each subject was formulated
accordingly.
[0333] A total of 368 subjects began the study. 222 subjects
received the low-volume IDPN compositions, and 146 subjects
received the high-volume IDPN compositions. In the low-volume
group, 21 subjects were disqualified for having base line albumin
levels greater than 3.5 g/dL, and 1 for providing incomplete
information. In the high-volume group, 19 subjects were
disqualified for having base line serum albumin levels greater than
3.5 g/dL, and 2 for providing incomplete data. Of the 325 subjects
who completed the study, 200 were in the low-volume group and 125
were in the high-volume group. 139 subjects in the low-volume group
and 70 subjects in the high-volume group were diabetic. A survey of
the body mass index of all subjects found that the average body
mass index of the subjects in the low-volume, low-carbohydrate
group was higher than that of the subjects in the high-volume,
high-carbohydrate group.
[0334] A comparison was made of all subjects remaining in the
low-volume and high-volume IDPN groups. The low-volume group had a
baseline mean serum albumin of 2.90.+-.0.46 g/dL, and a 3 month
mean serum albumin of 3.19.+-.0.39 g/dL. The high-volume group had
a baseline mean serum albumin of 2.92.+-.0.45 g/dL, and a 3 month
mean serum albumin of 3.17.+-.0.51 g/dL. The gain in mean serum
albumin for the low-volume group was 0.29.+-.0.46 g/dL. The gain in
mean serum albumin for the high-volume group was 0.24.+-.0.41 g/dL.
Analysis by t-test resulted in a p=0.18, above the threshold of
p=0.05 for statistical significance. The results are illustrated in
FIG. 39.
[0335] A separate comparison was made of the diabetic subjects
receiving low-volume versus high-volume IDPN compositions. The
diabetic low-volume group had a baseline mean serum albumin of
2.89.+-.0.48 g/dL, and a 3 month mean serum albumin of 3.21.+-.0.37
g/dL. The diabetic high-volume group had a baseline mean serum
albumin of 2.92.+-.0.40, and a 3 month mean serum albumin of
3.11.+-.0.49 g/dL. The gain in mean serum albumin for the diabetic
low-volume group was 0.32.+-.0.47 g/dL. The gain in mean serum
albumin for the diabetic high-volume group was 0.20.+-.0.35.
Analysis by t-test resulted in a p=0.018, below the threshold of
p=0.05 for statistical significance. The results are illustrated in
FIG. 40.
[0336] In this study, 15 subjects exhibited a mean serum albumin
increase of >1.0 g/dL. 14 of these 15 subjects had received the
low-volume IDPN composition. 12 of these 14 were diabetic.
[0337] The low-volume, low-carbohydrate group, having a greater
average body mass index than the high-volume, high-carbohydrate
group, responded to therapy despite having larger physical size and
higher caloric needs. This counter-intuitive observation suggests
that subjects of varying body size can benefit from the advantages
of the low-volume therapy.
[0338] FIG. 41 illustrates the levels of increase or decrease in
serum albumin among subjects receiving the low-volume IDPN
composition. Subjects of sub-population A (33 subjects; 16% of
total subjects receiving the low-volume IDPN composition) exhibited
an albumin decrease of 0.01 to 0.5 g/dL. Subjects of sub-population
B (15 subjects; 8% of total subjects receiving the low-volume IDPN
composition) exhibited an albumin increase of 0 g/dL. Subjects of
sub-population C (104 subjects; 51% of total subjects receiving the
low-volume IDPN composition) exhibited an albumin increase of 0.01
to 0.5 g/dL. Subjects of sub-population D (31 subjects; 16% of
total subjects receiving the low-volume IDPN composition) exhibited
an albumin increase of 0.51 to 1 g/dL. Subjects of sub-population E
(14 subjects; 7% of total subjects receiving the low-volume IDPN
composition) exhibited an albumin increase of greater than 1 g/dL.
Subjects of sub-population F (2 subjects; 1% of total subjects
receiving the low-volume IDPN composition) exhibited an albumin
decrease of greater than 1 g/dL. Subjects of sub-population G (1
subjects; 1% of total subjects receiving the low-volume IDPN
composition) exhibited an albumin decrease of 0.51 to 1 g/dL.
[0339] FIG. 42 illustrates the levels of increase or decrease in
serum albumin among subjects receiving the high-volume IDPN
composition. Subjects of sub-population A (24 subjects; 19% of
total subjects receiving the high-volume IDPN composition)
exhibited an albumin decrease of 0.01 to 0.5 g/dL. Subjects of
sub-population B (8 subjects; 6% of total subjects receiving the
high-volume IDPN composition) exhibited an albumin increase of 0
g/dL. Subjects of sub-population C (62 subjects; 49% of total
subjects receiving the high-volume IDPN composition) exhibited an
albumin increase of 0.01 to 0.5 g/dL. Subjects of sub-population D
(27 subjects; 22% of total subjects receiving the high-volume IDPN
composition) exhibited an albumin increase of 0.51 to 1 g/dL.
Subjects of sub-population E (1 subjects; 1% of total subjects
receiving the high-volume IDPN composition) exhibited an albumin
increase of greater than 1 g/dL. Subjects of sub-population F (1
subjects; 1% of total subjects receiving the high-volume IDPN
composition) exhibited an albumin decrease of greater than 1 g/dL.
Subjects of sub-population G (2 subjects; 2% of total subjects
receiving the high-volume IDPN composition) exhibited an albumin
decrease of 0.51 to 1 g/dL.
[0340] FIG. 43 illustrates the levels of increase or decrease in
serum albumin among diabetic subjects to the low-volume IDPN
composition. Subjects of sub-population A (22 subjects; 16% of
diabetic subjects receiving the low-volume IDPN composition)
exhibited an albumin decrease of 0.01 to 0.5 g/dL. Subjects of
sub-population B (14 subjects; 10% of diabetic subjects receiving
the low-volume IDPN composition) exhibited an albumin increase of 0
g/dL. Subjects of sub-population C (71 subjects; 50% of diabetic
subjects receiving the low-volume IDPN composition) exhibited an
albumin increase of 0.01 to 0.5 g/dL. Subjects of sub-population D
(19 subjects; 14% of diabetic subjects receiving the low-volume
IDPN composition) exhibited an albumin increase of 0.51 to 1 g/dL.
Subjects of sub-population E (12 subjects; 9% of diabetic subjects
receiving the low-volume IDPN composition) exhibited an albumin
increase of greater than 1 g/dL. Subjects of sub-population F (1
subjects; 1% of diabetic subjects receiving the low-volume IDPN
composition) exhibited an albumin decrease of greater than 1 g/dL.
Zero subjects receiving the low-volume IDPN composition exhibited
an albumin decrease of 0.51 to 1 g/dL.
[0341] FIG. 44 illustrates the levels of increase or decrease in
serum albumin among non-diabetic subjects to the low-volume IDPN
composition. Subjects of sub-population A (11 subjects; 18% of
non-diabetic subjects receiving the low-volume IDPN composition)
exhibited an albumin decrease of 0.01 to 0.5 g/dL. Subjects of
sub-population B (1 subjects; 2% of non-diabetic subjects receiving
the low-volume IDPN composition) exhibited an albumin increase of 0
g/dL. Subjects of sub-population C (33 subjects; 53% of
non-diabetic subjects receiving the low-volume IDPN composition)
exhibited an albumin increase of 0.01 to 0.5 g/dL. Subjects of
sub-population D (12 subjects; 20% of non-diabetic subjects
receiving the low-volume IDPN composition) exhibited an albumin
increase of 0.51 to 1 g/dL. Subjects of sub-population E (2
subjects; 3% of non-diabetic subjects receiving the low-volume IDPN
composition) exhibited an albumin increase of greater than 1 g/dL.
Subjects of sub-population F (1 subjects; 2% of non-diabetic
subjects receiving the low-volume IDPN composition) exhibited an
albumin decrease of greater than 1 g/dL. Subjects of sub-population
G (1 subjects; 2% of non-diabetic subjects receiving the low-volume
IDPN composition) exhibited an albumin decrease of 0.51 to 1
g/dL.
* * * * *