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

Condition(s) targeted: Hemodialysis; Malnutrition

Intervention: Intradialytic parenteral nutrition (Drug)

Phase: Phase 4

Status: Terminated

Sponsored by: EZUS-LYON 1

Official(s) and/or principal investigator(s):
Noel JM Cano, MD-PhD, Study Director, Affiliation: Unaffiliated

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

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

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Primary outcome: mortality

Secondary outcome: hospitalization rate, Karnofsky score, BMI, serum albumin and prealbumin

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.

Minimum age: 18 Years. Maximum age: 82 Years. Gender(s): Both.

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

Starting date: January 2001
Ending date: December 2004
Last updated: April 14, 2006