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

Primary Purpose

End Stage Renal Disease

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Nepro nutritional supplement
Sponsored by
Vanderbilt University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for End Stage Renal Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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: 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 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. Biochemical parameters of malnutrition defined by one of the following measurements over the consecutive two months prior to inclusion: Serum albumin less than 4.0 g/dl Serum transferrin concentration less than 250 mg/dl Serum prealbumin concentration less than 32 mg/dl 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.

Sites / Locations

  • National Kidney Foundation

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

increase in serum albumin

Secondary Outcome Measures

Full Information

First Posted
September 13, 2005
Last Updated
May 27, 2014
Sponsor
Vanderbilt University
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1. Study Identification

Unique Protocol Identification Number
NCT00179153
Brief Title
Improving The Nutritional Status Of The Malnourished Chronic Hemodialysis Patients In The State Of Tennessee
Official Title
Improving The Nutritional Status Of The Malnourished Chronic Hemodialysis Patients In The State Of Tennessee
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
February 2005 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
352 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Nepro nutritional supplement
Intervention Description
oral nutritional supplement (Nepro); every other day, 3 days per week, for 6 months
Primary Outcome Measure Information:
Title
increase in serum albumin
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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: 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 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. Biochemical parameters of malnutrition defined by one of the following measurements over the consecutive two months prior to inclusion: Serum albumin less than 4.0 g/dl Serum transferrin concentration less than 250 mg/dl Serum prealbumin concentration less than 32 mg/dl 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alp Ikizler, MD
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Kidney Foundation
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37215
Country
United States

12. IPD Sharing Statement

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

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