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

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.

Study Overview

• Status: Completed
• Conditions: End Stage Renal Disease
• Intervention / Treatment: Dietary supplement: Nepro nutritional supplement

• Study Type: Interventional
• Enrollment (Actual): 352
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37215
      • National Kidney Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 1	Dietary supplement: Nepro nutritional supplement; oral nutritional supplement (Nepro); every other day, 3 days per week, for 6 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
increase in serum albumin	6 months

Collaborators and Investigators

• Sponsor: Vanderbilt University
• Investigators: Principal Investigator: Alp Ikizler, MD, Vanderbilt University Medical Center

Study record dates

Study Major Dates

• Study Start: February 1, 2005
• Primary Completion (Actual): May 1, 2009
• Study Completion (Actual): May 1, 2009

Study Registration Dates

• First Submitted: September 13, 2005
• First Submitted That Met QC Criteria: September 13, 2005
• First Posted (Estimate): September 15, 2005

Study Record Updates

• Last Update Posted (Estimate): May 29, 2014
• Last Update Submitted That Met QC Criteria: May 27, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Failure, Chronic
• Other Study ID Numbers: 040345