Oxidative Stress and Hemodialysis Access Failure
| Status: | Completed |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease, Renal Impairment / Chronic Kidney Disease |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | 21 - Any |
| Updated: | 4/21/2016 |
| Start Date: | May 2001 |
| End Date: | May 2004 |
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
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.
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.
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.
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.
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
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