Status:
COMPLETED
Improving The Nutritional Status Of The Malnourished Chronic Hemodialysis Patients In The State Of Tennessee
Lead Sponsor:
Vanderbilt University
Conditions:
End Stage Renal Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 p...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
352 Patients enrolled
Trial Details
Trial ID
NCT00179153
Start Date
February 1 2005
End Date
May 1 2009
Last Update
May 29 2014
Active Locations (1)
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1
National Kidney Foundation
Nashville, Tennessee, United States, 37215