Status:
TERMINATED
Effect of Intradialytic Parenteral Nutrition on Morbidity and Mortality of Malnourished Hemodialysis Patients
Lead Sponsor:
EZUS-LYON 1
Collaborating Sponsors:
Institut National de la Santé Et de la Recherche Médicale, France
Societe Francaise de Dialyse
Conditions:
Hemodialysis
Malnutrition
Eligibility:
All Genders
18-82 years
Phase:
PHASE4
Brief Summary
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 effi...
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 effi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2001
Trial Type :
INTERVENTIONAL
End Date :
December 1 2004
Estimated Enrollment :
204 Patients enrolled
Trial Details
Trial ID
NCT00314834
Start Date
January 1 2001
End Date
December 1 2004
Last Update
April 17 2006
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