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

Phase 4

Terminated

• Conditions: Hemodialysis; Malnutrition

• Registration Number: NCT00314834
• Lead Sponsor: EZUS-LYON 1

Brief 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

Detailed Description

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.

Patient eligibility: adult patients ≤ 82 y with HD vintage \> 6 mo. and 2 of the following malnutrition criteria: BMI ≤ 20 kg/m2, BW loss/6 mo. ≥ 10%, serum albumin ≤ 35 g/L, prealbumin ≤ 300 mg/L.

Recruitment: patients in 38 HD units from January 2001 to December 2002 Study protocol. Patients are randomized into 2 groups: IDPN group, given IDPN during one year, and control group. For ethical reasons, the 2 groups are given oral supplementation during the same period.

Follow-up: two years after start of nutritional therapy. Study end: December 31, 2004. Final results will be available in early 2005.

Study Timeline

• Study Start: 2001-01
• Study Completion: 2004-12
• Status Verified: 2005-03
• Study First Submitted: 2006-04-14
• Study First Submitted QC: 2006-04-14
• Last Update Submitted: 2006-04-14
• Study First Posted: 2006-04-17
• Last Update Posted: 2006-04-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 204

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
mortality

Secondary Outcome Measures

Name	Time	Method
hospitalization rate, Karnofsky score, BMI, serum albumin and prealbumin