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

End Stage Renal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00179153
• Other study ID #: 040345
• Status: Completed
• Phase: Phase 2
• First received: September 13, 2005
• Last updated: May 27, 2014
• Start date: February 2005
• Est. completion date: May 2009

Study information

• Verified date: May 2014
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 352
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Failure, Chronic

Intervention

Dietary Supplement:
• Nepro nutritional supplement
oral nutritional supplement (Nepro); every other day, 3 days per week, for 6 months

Locations

Country	Name	City	State
United States	National Kidney Foundation	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	increase in serum albumin		6 months	No