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

Malnutrition Clinical Trial

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

Status Terminated

Clinical Trial 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

Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemodialysis
• Malnutrition

• NCT number: NCT00314834
• Study type: Interventional
• Source: EZUS-LYON 1
• Status: Terminated
• Phase: Phase 4
• Start date: January 2001
• Completion date: December 2004