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

Phase 4TerminatedNCT00314834

EZUS-LYON 1204 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

204

Conditions

Hemodialysis Malnutrition

Interventions

Intradialytic parenteral nutritionDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 82 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

mortality

Secondary Outcomes

hospitalization rate, Karnofsky score, BMI, serum albumin and prealbumin

Data from ClinicalTrials.gov

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