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Oxidative Stress and Hemodialysis Access Failure

This study has been completed.
Leonard B Rosenberg Renal Research Foundation
Information provided by:
National Institute of Environmental Health Sciences (NIEHS) Identifier:
First received: December 11, 2006
Last updated: October 5, 2015
Last verified: December 2006
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.

Condition Intervention Phase
End Stage Renal Disease Hemodialysis Drug: Alpha tocopherol Phase 4

Study Type: Observational
Study Design: Time Perspective: Prospective
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

Resource links provided by NLM:

Further study details as provided by National Institute of Environmental Health Sciences (NIEHS):

Estimated Enrollment: 35
Study Start Date: May 2001
Estimated Study Completion Date: May 2004
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.

Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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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Please refer to this study by its identifier: NCT00410449

United States, Ohio
Center for Dialysis Care
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
National Institute of Environmental Health Sciences (NIEHS)
Leonard B Rosenberg Renal Research Foundation
Principal Investigator: Miriam F Weiss, M.D. Case Western Reserve University
  More Information

Publications: Identifier: NCT00410449     History of Changes
Other Study ID Numbers: 11461-CP-001
Study First Received: December 11, 2006
Last Updated: October 5, 2015

Keywords provided by National Institute of Environmental Health Sciences (NIEHS):
End stage renal disease treated by hemodialysis
Hemodialysis vascular access patency
Vitamin E
oxidative markers

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency
Vitamin E
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Growth Substances processed this record on September 19, 2017