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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
  Purpose

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: Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Longitudinal
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:

U.S. FDA Resources

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00410449

Locations
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
Investigators
Principal Investigator: Miriam F Weiss, M.D. Case Western Reserve University
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00410449     History of Changes
Other Study ID Numbers: 11461-CP-001, NIEHS ES11461
Study First Received: December 11, 2006
Last Updated: December 11, 2006
Health Authority: United States: Federal Government

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
 pentosidine
hydroxynonenal
levuglandin

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Vitamin E
Alpha-Tocopherol
Tocopherols
Tocotrienols
 Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs
Vitamins
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on May 21, 2013