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

Vanderbilt University

Status and phase

Completed

Phase 2

Conditions

End Stage Renal Disease

Treatments

Dietary Supplement: Nepro nutritional supplement

Study type

Interventional

Funder types

Other

Identifiers

NCT00179153

040345

Details and patient eligibility

About

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.

Enrollment

352 patients

Sex

All

Ages

18+ years old

Volunteers

No 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:
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.