Overview

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