Anit-Inflammatory and Anti-Oxidative Nutrition in Dialysis Patients

• Status: Completed
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: All

Summary

Study of efficiency and safety of oral nutritional supplements with anti-inflammatory and antioxidative properties combined with an appetite stimulant with anti-inflammatory properties (pentoxiphylline) in treatment of malnutrition-inflammation-cachexia syndrome in maintenance hemodialysis patients

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Los Angeles Biomedical Research Institute; Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
• Collaborators: Abbott Nutrition; DaVita Dialysis
• Treatments: Anti-Inflammatory Agents; Pentoxifylline; Polystyrene sulfonic acid

Criteria

Inclusion Criteria:

• At least 3 months on maintenance hemodialysis,

• Last 3-month averaged serum albumin <4.0 g/dl,

• Average monthly Kt/V>1.2,

• Dialysis time between 3 and 5 hours,

• Functioning AV graft or fistula or tunnel catheter that will not switch for 6 months,

• Standardized dialysis treatment per DaVita protocol.

• In case the averaged 3-month is not <4.0 g/dl but last month serum albumin <4.0 g/dl (worsening hypoalbuminemia) patient will be qualified, if 3-month averaged nPNA < 0.8 g/kg/day or a BMI < 20 kg/m2.

Exclusion Criteria:

• Peritoneal dialysis

• Terminal illnesses with life expectancy<6 months

• Maintenance hemodialysis less than 5 months

• Concurrent appetite stimulants

• Use of IDPN in the past 2-3 months

• Inability to follow and to comply with the instructions and guidelines

• Likelihood of pregnancy or intention to become pregnant

• Acute wasting condition or active systemic disease

• Pulse chemo therapy

• Non-compliance with dialysis treatment

• Dialysis catheter that may switch soon.