Oxidative Stress and Hemodialysis Access Failure

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00410449
Recruitment Status : Completed
First Posted : December 12, 2006
Last Update Posted : October 6, 2015
Leonard B Rosenberg Renal Research Foundation
Information provided by:
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.

Condition or disease Intervention/treatment
End Stage Renal Disease Hemodialysis Drug: Alpha tocopherol

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.

Study Type : Observational
Enrollment : 35 participants
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
Study Start Date : May 2001
Study Completion Date : May 2004

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Publications of Results: Identifier: NCT00410449     History of Changes
Other Study ID Numbers: 11461-CP-001
First Posted: December 12, 2006    Key Record Dates
Last Update Posted: October 6, 2015
Last Verified: December 2006

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
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Vitamin E
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Growth Substances