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

• Sponsor: EZUS-LYON 1 (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00314834
• Collaborator: Institut National de la Santé Et de la Recherche Médicale, France (Other), Societe Francaise de Dialyse (Other), Societe Francophone de Nutrition Enterale et Parenterale (Other)
• Enrollment: 204
• Duration (Months): 47

Study Details

Study Description

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 efficacy, Karnofsky score

Condition or Disease	Intervention/Treatment	Phase
Hemodialysis; Malnutrition	Drug: Intradialytic parenteral nutrition	Phase 4

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.

Study Design

• Study Type: Interventional
• 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
• Study Start Date: Jan 1, 2001
• Study Completion Date: Dec 1, 2004

Outcome Measures

Primary Outcome Measures

1. mortality []

Secondary Outcome Measures

1. hospitalization rate, Karnofsky score, BMI, serum albumin and prealbumin []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 82 Years
• Sexes Eligible for Study: All
• 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

Locations

No locations specified.

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,

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00314834
• Other Study ID Numbers: EZUS-A1244
• First Posted: Apr 17, 2006
• Last Update Posted: Apr 17, 2006
• Last Verified: Mar 1, 2005

• Keywords provided by , ,: hemodialysis; intradialytic parenteral nutrition; oral supplementation; survival; hospitalization; serum albumin; prealbumin; transthyretin
• Additional relevant MeSH terms: Malnutrition

Study Results

No Results Posted as of Apr 17, 2006