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Oxidative Stress and Hemodialysis Access Failure

This study has been completed.
Sponsor:
Collaborator:
Leonard B Rosenberg Renal Research Foundation
Information provided by:
National Institute of Environmental Health Sciences (NIEHS)
ClinicalTrials.gov Identifier:
NCT00410449
First received: December 11, 2006
Last updated: NA
Last verified: December 2006
History: No changes posted

December 11, 2006
December 11, 2006
May 2001
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Oxidative Stress and Hemodialysis Access Failure
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.

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.

Observational
Observational Model: Defined Population
Time Perspective: Longitudinal
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  • End Stage Renal Disease
  • Hemodialysis
Drug: Alpha tocopherol
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Schwing WD, Erhard P, Newman LN, Nodge MM, Czechanski BJ, Orlin SM, Walden SM, Behm K, Cacho CP, Negrea LA, Siu DS, Kern EO, Weiss MF. Assessing 24-hour blood glucose patterns in diabetic paitents treated by peritoneal dialysis. Adv Perit Dial. 2004;20:213-6.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
35
May 2004
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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

Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00410449
11461-CP-001, NIEHS ES11461
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National Institute of Environmental Health Sciences (NIEHS)
Leonard B Rosenberg Renal Research Foundation
Principal Investigator: Miriam F Weiss, M.D. Case Western Reserve University
National Institute of Environmental Health Sciences (NIEHS)
December 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP