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

NCT ID: NCT00179153

Last Updated: 2014-05-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 352 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-02-28
• Study Completion Date: 2009-05-31

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.

Conditions

End Stage Renal Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: ACTIVE_COMPARATOR

Nepro nutritional supplement

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Nepro nutritional supplement

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

Intervention Type: DIETARY_SUPPLEMENT

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:

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vanderbilt University

OTHER

Sponsor Role: lead

Responsible Party

Alp Ikizler

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alp Ikizler, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

National Kidney Foundation

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

040345

Identifier Type: -

Identifier Source: org_study_id