Effect of Intradialytic Parenteral Nutrition on Morbidity and Mortality of Malnourished Hemodialysis Patients
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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 |
- mortality
- hospitalization rate, Karnofsky score, BMI, serum albumin and prealbumin
| Estimated Enrollment: | 204 |
| Study Start Date: | January 2001 |
| Estimated Study Completion Date: | December 2004 |
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 |
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| 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 June 13, 2013