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

April 14, 2006 updated by: EZUS-LYON 1
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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment

204

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
mortality

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

Investigators

  • Study Director: Noel JM Cano, MD-PhD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2001

Study Completion

December 1, 2004

Study Registration Dates

First Submitted

April 14, 2006

First Submitted That Met QC Criteria

April 14, 2006

First Posted (Estimate)

April 17, 2006

Study Record Updates

Last Update Posted (Estimate)

April 17, 2006

Last Update Submitted That Met QC Criteria

April 14, 2006

Last Verified

March 1, 2005

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EZUS-A1244

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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