Oxidative Stress and Hemodialysis Access Failure
Complications of hemodialysis access are the most frequent single reason for hospitalization among patients with End Stage Renal Disease (ESRD). Uremia, and particularly uremia in patients with diabetes, is a state of increased oxidative stress. The central hypothesis to be tested by this project is that oxidative stress is a major (and modifiable) trigger for vascular access complications. We hope to slow or reduce rates of stenosis, thrombosis and access complications by giving Vitamin E supplementation to patients being treated by hemodialysis.
|Study Design:||Observational Model: Defined Population
Time Perspective: Longitudinal
|Official Title:||Study of the Effect of Oral Supplementation With Vitamin E on Circulating Oxidative Markers, Hemodialysis Vascular Access Occlusion, and Clinical Events in Patients With End Stage Renal Failure Treated by Hemodialysis|
|Study Start Date:||May 2001|
|Estimated Study Completion Date:||May 2004|
Patients continued their usual treatment on hemodialysis three times per week. This was a double-blinded placebo controlled trial. Patients took either Vitamin E 400 IU bid or placebo. An initial evaluation of access patency was performed and baseline blood drawn before starting Vitamin E. Every 3 months there was a followup evaluation with blood drawn for oxidative stress markers, and with a test of vascular access patency. The study was closed to new participants, vitamin E or placebo stopped, and data analysis performed in 2003.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00410449
|United States, Ohio|
|Center for Dialysis Care|
|Cleveland, Ohio, United States, 44106|
|Principal Investigator:||Miriam F Weiss, M.D.||Case Western Reserve University|