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Nashville, Tennessee 37232

  • End Stage Renal Disease

Purpose:

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.


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


NCT ID:

NCT00179205


Primary Contact:

Principal Investigator
Alp Ikizler, MD
Vanderbilt University


Backup Contact:

N/A


Location Contact:

Nashville, Tennessee 37232
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: April 07, 2020

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