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.

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.