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

This study has been terminated.

First Received: April 14, 2006 No Changes Posted

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
Information provided by:	EZUS-LYON 1
ClinicalTrials.gov Identifier:	NCT00314834

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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Effect of Intradialytic Parenteral Nutrition on Morbidity and Mortality of Malnourished Hemodialysis Patients

Resource links provided by NLM:

MedlinePlus related topics: Dialysis Kidney Failure

U.S. FDA Resources

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:

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

Unaffiliated

More Information

No publications provided by EZUS-LYON 1

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

Cano NJ, Fouque D, Roth H, Aparicio M, Azar R, Canaud B, Chauveau P, Combe C, Laville M, Leverve XM; French Study Group for Nutrition in Dialysis. Intradialytic parenteral nutrition does not improve survival in malnourished hemodialysis patients: a 2-year multicenter, prospective, randomized study. J Am Soc Nephrol. 2007 Sep;18(9):2583-91. Epub 2007 Jul 26.

Study ID Numbers:	EZUS-A1244
Study First Received:	April 14, 2006
Last Updated:	April 14, 2006
ClinicalTrials.gov Identifier:	NCT00314834 History of Changes
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 February 08, 2010