Effect of Intradialytic Parenteral Nutrition on Morbidity and Mortality of Malnourished Hemodialysis Patients

• Status: Terminated
• Trial end date: 2004-12-01
• Target enrollment: 0
• Participant gender: All

Summary

IDPN is widely used in HD patients without clue of its effectiveness. Study objectives: to evaluate IDPN effects on mortality (main objective), hospitalization rates, nutritional status, dialysis efficacy, Karnofsky score

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: EZUS-LYON 1
• Collaborators: Institut National de la Santé Et de la Recherche Médicale, France; Societe Francaise de Dialyse; Societe Francophone de Nutrition Enterale et Parenterale

Criteria

Inclusion Criteria:

• age between 18 and 82 years

• hemodialysis vintage more than 6 months

• two of the following markers of malnutrition:

• body mass index (BMI) <= 20 kg/m2

• body weight loss within 6 months >= 10 percent

• serum albumin <= 35 g/L

• prealbumin <= 300 mg/L

Exclusion Criteria:

• weekly dialysis time < 12 h

• urea Kt/V index < 1.2

• serum albumin > 38 g/L

• prealbumin > 330 mg/L

• hypertriglyceridemia > 2.5 mmol/L

• associated comorbidities compromising the one-year survival

• treatment by oral, enteral or parenteral feeding during the last 3 months

• hospitalization at time of randomization