Improving The Nutritional Status Of The Malnourished Chronic Hemodialysis Patients In The State Of Tennessee

Phase 2

Completed

• Conditions: End Stage Renal Disease
• Interventions: Dietary Supplement: Nepro nutritional supplement

• Registration Number: NCT00179153
• Lead Sponsor: Vanderbilt University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-02
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-15
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-27
• Last Update Posted: 2014-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 352

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Nepro nutritional supplement	-

Primary Outcome Measures

Name	Time	Method
increase in serum albumin	6 months

Trial Locations

Locations (1)

National Kidney Foundation; 🇺🇸 Nashville, Tennessee, United States