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

This study has been terminated.
Sponsor:
Collaborators:
Institut National de la Santé Et de la Recherche Médicale, France
Societe Francaise de Dialyse
Societe Francophone de Nutrition Enterale et Parenterale
Information provided by:
EZUS-LYON 1
ClinicalTrials.gov Identifier:
NCT00314834
First received: April 14, 2006
Last updated: NA
Last verified: March 2005
History: No changes posted
  Purpose

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


Condition Intervention Phase
Hemodialysis
Malnutrition
Drug: Intradialytic parenteral nutrition
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Intradialytic Parenteral Nutrition on Morbidity and Mortality of Malnourished Hemodialysis Patients

Resource links provided by NLM:


Further study details as provided by EZUS-LYON 1:

Primary Outcome Measures:
  • mortality

Secondary Outcome Measures:
  • hospitalization rate, Karnofsky score, BMI, serum albumin and prealbumin

Estimated Enrollment: 204
Study Start Date: January 2001
Estimated Study Completion Date: December 2004
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.

  Eligibility

Ages Eligible for Study:   18 Years to 82 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00314834

Sponsors and Collaborators
EZUS-LYON 1
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
  More Information

No publications provided by EZUS-LYON 1

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00314834     History of Changes
Other Study ID Numbers: EZUS-A1244
Study First Received: April 14, 2006
Last Updated: April 14, 2006
Health Authority: France: Ministry of Health

Keywords provided by EZUS-LYON 1:
hemodialysis
intradialytic parenteral nutrition
oral supplementation
survival
hospitalization
serum albumin
prealbumin
transthyretin

Additional relevant MeSH terms:
Malnutrition
Nutrition Disorders

ClinicalTrials.gov processed this record on April 17, 2014