End Stage Renal Disease, Hemodialysis
Conditions
Keywords
End stage renal disease treated by hemodialysis, Hemodialysis vascular access patency, Vitamin E, oxidative markers, pentosidine, hydroxynonenal, levuglandin
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.
Interventions
Sponsors
Study design
Eligibility
Inclusion criteria
Adults, end stage renal disease treated by hemodialysis, patent hemodialysis vascular access (graft or fistula)
Exclusion criteria
Temporary catheter dialysis access, inability to be compliant with study medication
Countries
United States