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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 22, 2014