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.

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...

AI Technical Summary

Benefits of technology

[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.

[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.

[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.

Problems solved by technology

Severe malnutrition remains a problem for subjects receiving maintenance hemodialysis (MHD).

Dialysis subjects often have poor appetites and low energy.

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.

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.

Hyperglycemia is a major barrier to effective nutrition support even outside the context of hemodialysis.

Moreover, the amount of fluid in typical IDPN treatment is a barrier to use in subjects with strict fluid management.

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