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Nashville, Tennessee 37215

  • End Stage Renal Disease

Purpose:

We propose to identify malnourished chronic kidney dialysis patients through a statewide effort and subsequently treat them based on a protocol (provision of oral nutritional supplementation) over a period of six (6) months.


Criteria:

Inclusion Criteria: - On CHD dialysis for more than 6 months - Adequately dialyzed (Kt/V > 1.0) with a biocompatible hemodialysis membrane. Patients with Kt/V > 1.0 but < 1.4 will be evaluated for etiologies of lower than optimal dialysis dose and every effort will be made to increase the Dialysis dose to 1.4 or above. Patients with all access types will be recruited to the study. - Suboptimal nutritional status identified by one of the following criteria: 1. Protein catabolic rate less than 1.0 g/kg/d calculated by three-point urea kinetic modeling on at least 2 occasions over the past 3 months 2. Progressive unintentional weight loss more than 2.5% of the initial or ideal body weight and/or patients who are less than 90% of ideal body weight. 3. Biochemical parameters of malnutrition defined by one of the following measurements over the consecutive two months prior to inclusion: 1. Serum albumin less than 4.0 g/dl 2. Serum transferrin concentration less than 250 mg/dl 3. Serum prealbumin concentration less than 32 mg/dl 4. Subjective Global Assessment Score less than 5. Exclusion Criteria: - Intolerance to nutritional supplementation (unable to tolerate any of the nutritional supplements available) - Refusal to sign a consent form - On nutritional supplementation (IDPN or PO) within 2 weeks of the study initiation.


NCT ID:

NCT00179153


Primary Contact:

Principal Investigator
Alp Ikizler, MD
Vanderbilt University


Backup Contact:

N/A


Location Contact:

Nashville, Tennessee 37215
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: March 26, 2020

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