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

Study Overview
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Brief Summary
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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

Detailed Description
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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.

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

Conditions
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Hemodialysis, Malnutrition

Intervention / Treatment
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* Drug: Intradialytic parenteral nutrition


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 82 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Intradialytic parenteral nutrition|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hospitalization rate, Karnofsky score, BMI, serum albumin and prealbumin |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hemodialysis, intradialytic parenteral nutrition, oral supplementation, survival, hospitalization, serum albumin, prealbumin, transthyretin