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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00314834
First Posted: April 17, 2006
Last Update Posted: April 17, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
  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
Intervention Model: Parallel Assignment
Masking: None (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 82 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: April 14, 2006
First Posted: April 17, 2006
Last Update Posted: April 17, 2006
Last Verified: March 2005

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