Oxidative Stress and Hemodialysis Access Failure
- Conditions
- HemodialysisEnd Stage Renal Disease
- Registration Number
- NCT00410449
- Lead Sponsor
- National Institute of Environmental Health Sciences (NIEHS)
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 35
Adults, end stage renal disease treated by hemodialysis, patent hemodialysis vascular access (graft or fistula)
Temporary catheter dialysis access, inability to be compliant with study medication
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Center for Dialysis Care
🇺🇸Cleveland, Ohio, United States
Center for Dialysis Care🇺🇸Cleveland, Ohio, United States