Complementary Intradialytic Nutritional Supplementation in Dialysis Patients

• Status: Terminated
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

Summary

In this study, the investigators hypothesize that long-term administration of adequate intradialytic oral nutritional supplementation will increase visceral protein concentrations and somatic protein stores in malnourished chronic hemodialysis patients.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vanderbilt University; Vanderbilt University Medical Center
• Collaborator: Ross Laboratories

Criteria

Inclusion Criteria:

1. On hemodialysis for more than 6 months

2. Optimally dialyzed with a biocompatible membrane (URR > 70% and/or delivered Kt/V > 1.2)

3. Suboptimal nutritional status identified by:

• Serum albumin less than or equal to 3.90 g/dl and one of the three following criteria:

• Protein catabolic rate less than 0.95 g/kg/d calculated by three point urea kinetic modeling on at least 2 occasions over the past 6 months

• Progressive unintentional weight loss more than 2.5% of the initial or ideal body weight over the past 6 months and/or patients who are less than 90% of standard body weight

• Biochemical parameters of malnutrition defined by 1 of 2 of the following measurements over the consecutive two months prior to inclusion:

• Serum transferrin concentration less than 225 mg/dl

• Serum prealbumin concentration less than 32 mg/dl

Exclusion Criteria:

1. Active auto-immune, inflammatory or infectious disease

2. Documented malignancy within the last 12 months

3. Patients on unusual dietary restrictions

4. Life-expectancy less than 6 months

5. Inability to tolerate nutritional supplements