NUTRITIVE COMPOSITIONS AND METHODS OF USING SAME
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 . A sterile aqueous intradialytic parenteral, nutrition (IDPN) solution, comprising between 0.02 g/mL and 0.1 g/mL of dextrose and between 0.1 g/mL and 0.2 g/mL of amino acids, wherein the solution is lipid-free and the dextrose and the amino acids are both present in the same aqueous solution, and wherein the IDPN solution, when administered to a human subject in need thereof as part of an intradialytic parenteral nutrition treatment regimen over a period of at least three months, produces a sustained increase in the serum albumin level in the blood of the subject from about 0.01 g/dL to about 1.0 g/dL.
2 . The sterile aqueous IDPN solution of claim 1 , wherein the IDPN solution comprises between 0.04 g/mL and 0.08 g/mL of dextrose and between 0.12 g/mL and 0.18 g/mL of amino acids.
3 . The sterile aqueous IDPN solution of claim 1 , wherein the IDPN solution comprises between 0.05 g/mL and 0.07 g/mL of dextrose and between 0.15 g/mL and 0.17 g/mL of amino acids.
4 . The sterile aqueous IDPN solution of claim 1 , wherein the IDPN solution comprises between 0.04 g/mL and 0.08 g/mL of dextrose and between 0.15 g/mL and 0.17 g/mL of amino acids.
5 . The sterile aqueous IDPN solution of claim 1 , wherein the IDPN solution comprises between 0.05 g/mL and 0.07 g/mL of dextrose and between 0.12 g/mL and 0.18 g/mL of amino acids.
6 . The sterile aqueous IDPN solution of claim 1 , wherein the IDPN solution comprises between 0.12 g/mL and 0.18 g/mL of amino acids.
7 . The sterile aqueous IDPN solution of claim 1 , wherein the IDPN solution comprises between 0.15 g/mL and 0.17 g/mL of amino acids.
8 . The sterile aqueous IDPN solution of claim 1 , wherein the IDPN solution comprises vitamins and minerals.
9 . The sterile aqueous IDPN solution of claim 1 , wherein the IDPN solution, when administered to a human subject in need thereof as part of an intradialytic parenteral nutrition treatment regimen over a period of at least three months, produces a sustained increase in the serum albumin level in the blood of the subject from about 0.1 g/dL to about 0.6 g/dL.
10 . The sterile aqueous IDPN solution of claim 1 , wherein the IDPN solution, when administered to a human subject in need thereof as part of an intradialytic parenteral nutrition treatment regimen over a period of at least three months, produces a sustained increase in the serum albumin level in the blood of the subject from about 0.2 g/dL to about 0.4 g/dL.
11 . The sterile aqueous IDPN solution of claim 1 , wherein the IDPN solution has a volume between about 100 mL and about 2 liters.
12 . The sterile aqueous IDPN solution of claim 1 , wherein the IDPN solution has a volume between about 350 mL and about 635 mL.
13 . A sterile aqueous IDPN solution comprising between 0.02 g/mL and 0.1 g/mL of dextrose, between 0.1 g/mL and 0.2 g/mL of amino acids, and between 0.01 g/mL and 0.05 g/mL of lipids, wherein the dextrose, the amino acids, and the lipids are all present in the same aqueous solution, and wherein the IDPN solution, when administered to a human subject in need thereof as part of an intradialytic parenteral nutrition treatment regimen over a period of at least three months, produces a sustained increase in the serum albumin level in the blood of the subject from about 0.01 g/dL to about 1.0 g/dL.
14 . The sterile aqueous IDPN solution of claim 13 , wherein the IDPN solution comprises between 0.04 g/mL and 0.08 g/mL of dextrose and between 0.12 g/mL and 0.18 g/mL of amino acids.
15 . The sterile aqueous IDPN solution of claim 13 , wherein the IDPN solution comprises between 0.05 g/mL and 0.07 g/mL of dextrose and between 0.15 g/mL and 0.17 g/mL of amino acids.
16 . The sterile aqueous IDPN solution of claim 13 , wherein the IDPN solution comprises between 0.04 g/mL and 0.08 g/mL of dextrose and between 0.15 g/mL and 0.17 g/mL of amino acids.
17 . The sterile aqueous IDPN solution of claim 13 , wherein the IDPN solution comprises between 0.05 g/mL and 0.07 g/mL of dextrose and between 0.12 g/mL and 0.18 g/mL of amino acids.
18 . The sterile aqueous IDPN solution of claim 13 , wherein the IDPN solution comprises between 0.12 g/mL and 0.18 g/mL of amino acids.
19 . The sterile aqueous IDPN solution of claim 13 , wherein the IDPN solution comprises between 0.15 g/mL and 0.17 g/mL of amino acids.
20 . The sterile aqueous IDPN solution of claim 13 , wherein the IDPN solution comprises vitamins and minerals.
21 . The sterile aqueous IDPN solution of claim 13 , wherein the IDPN solution, when administered to a human subject in need thereof as part of an intradialytic parenteral nutrition treatment regimen over a period of at least three months, produces a sustained increase in the serum albumin level in the blood of the subject from about 0.1 g/dL to about 0.6 g/dL.
22 . The sterile aqueous IDPN solution of claim 13 , wherein the IDPN solution, when administered to a human subject in need thereof as part of an intradialytic parenteral nutrition treatment regimen over a period of at least three months, produces a sustained increase in the serum albumin level in the blood of the subject from about 0.2 g/dL to about 0.4 g/dL.
23 . The sterile aqueous IDPN solution of claim 13 , wherein the IDPN solution has a volume between about 100 mL and about 2 liters.
24 . The sterile aqueous IDPN solution of claim 13 , wherein the IDPN solution has a volume between about 350 mL and about 635 mL.
25 . A sterile aqueous intradialytic parenteral, nutrition (IDPN) solution, consisting essentially of between 0.02 g/mL and 0.1 g/mL of dextrose and between 0.1 g/mL and 0.2 g/mL of amino acids, wherein the solution is lipid-free and the dextrose and the amino acids are both present in the same aqueous solution, and wherein the IDPN solution, when administered to a human subject in need thereof as part of an intradialytic parenteral nutrition treatment regimen over a period of at least three months, produces a sustained increase in the serum albumin level in the blood of the subject from about 0.01 g/dL to about 1.0 g/dL.
26 . The sterile aqueous IDPN solution of claim 25 , wherein the IDPN solution consists essentially of between 0.04 g/mL and 0.08 g/mL of dextrose and between 0.12 g/mL and 0.18 g/mL of amino acids.
27 . The sterile aqueous IDPN solution of claim 25 , wherein the IDPN solution consists essentially of between 0.05 g/mL and 0.07 g/mL of dextrose and between 0.15 g/mL and 0.17 g/mL of amino acids.
28 . The sterile aqueous IDPN solution of claim 25 , wherein the IDPN solution, when administered to a human subject in need thereof as part of an intradialytic parenteral nutrition treatment regimen over a period of at least three months, produces a sustained increase in the serum albumin level in the blood of the subject from about 0.1 g/dL to about 0.6 g/dL.
29 . The sterile aqueous IDPN solution of claim 25 , wherein the IDPN solution, when administered to a human subject in need thereof as part of an intradialytic parenteral nutrition treatment regimen over a period of at least three months, produces a sustained increase in the serum albumin level in the blood of the subject from about 0.2 g/dL to about 0.4 g/dL.
30 . A sterile aqueous IDPN solution, consisting essentially of between 0.02 g/mL and 0.1 g/mL of dextrose, between 0.1 g/mL and 0.2 g/mL of amino acids, and between 0.01 g/mL and 0.05 g/mL of lipids, wherein the dextrose, the amino acids, and the lipids are all present in the same aqueous solution, and wherein the IDPN solution, when administered to a human subject in need thereof as part of an intradialytic parenteral nutrition treatment regimen over a period of at least three months, produces a sustained increase in the serum albumin level in the blood of the subject from about 0.01 g/dL to about 1.0 g/dL.
31 . The sterile aqueous IDPN solution of claim 30 , wherein the IDPN solution consists essentially of between 0.04 g/mL and 0.08 g/mL of dextrose, between 0.12 g/mL and 0.18 g/mL of amino acids, and between 0.01 g/mL and 0.05 g/mL of lipids.
32 . The sterile aqueous IDPN solution of claim 30 , wherein the IDPN solution consists essentially of between 0.05 g/mL and 0.07 g/mL of dextrose, between 0.15 g/mL and 0.17 g/mL of amino acids, and between 0.01 g/mL and 0.05 g/mL of lipids.
33 . The sterile aqueous IDPN solution of claim 30 , wherein the IDPN solution, when administered to a human subject in need thereof as part of an intradialytic parenteral nutrition treatment regimen over a period of at least three months, produces a sustained increase in the serum albumin level in the blood of the subject from about 0.1 g/dL to about 0.6 g/dL.
34 . The sterile aqueous IDPN solution of claim 30 , wherein the IDPN solution, when administered to a human subject in need thereof as part of an intradialytic parenteral nutrition treatment regimen over a period of at least three months, produces a sustained increase in the serum albumin level in the blood of the subject from about 0.2 g/dL to about 0.4 g/dL.