Oxidative Stress and Hemodialysis Access Failure

NCT ID: NCT00410449

Last Updated: 2015-10-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 35 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2001-05-31
• Study Completion Date: 2004-05-31

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.

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.

Conditions

End Stage Renal Disease; Hemodialysis

Study Design

• Study Time Perspective: PROSPECTIVE

Interventions

Alpha tocopherol

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Leonard B Rosenberg Renal Research Foundation

UNKNOWN

Sponsor Role: collaborator

National Institute of Environmental Health Sciences (NIEHS)

NIH

Sponsor Role: lead

Principal Investigators

Miriam F Weiss, M.D.

Role: PRINCIPAL_INVESTIGATOR

Case Western Reserve University

Locations

Center for Dialysis Care

Cleveland, Ohio, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 15384829 (View on PubMed)

Other Identifiers

NIEHS ES11461

Identifier Type: -

Identifier Source: secondary_id

11461-CP-001

Identifier Type: -

Identifier Source: org_study_id