Oxidative Stress and Hemodialysis Access Failure
| Tracking Information | |||||
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| First Received Date ICMJE | December 11, 2006 | ||||
| Last Updated Date | December 11, 2006 | ||||
| Start Date ICMJE | May 2001 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Oxidative Stress and Hemodialysis Access Failure | ||||
| Official Title ICMJE | 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 | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Defined Population Observational Model: Natural History Time Perspective: Longitudinal Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Not Provided | ||||
| Study Population | Not Provided | ||||
| Condition ICMJE |
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| Intervention ICMJE | Drug: Alpha tocopherol | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | 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. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 35 | ||||
| Completion Date | May 2004 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | 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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| Gender | Both | ||||
| Ages | 21 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00410449 | ||||
| Other Study ID Numbers ICMJE | 11461-CP-001, NIEHS ES11461 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | National Institute of Environmental Health Sciences (NIEHS) | ||||
| Collaborators ICMJE | Leonard B Rosenberg Renal Research Foundation | ||||
| Investigators ICMJE |
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| Information Provided By | National Institute of Environmental Health Sciences (NIEHS) | ||||
| Verification Date | December 2006 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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