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| Sponsor: | Vanderbilt University |
|---|---|
| Information provided by: | Vanderbilt University |
| ClinicalTrials.gov Identifier: | NCT00179192 |
Purpose
Vascular access is considered the Achilles heel of the dialysis patient. It constitutes the largest single cause of morbidity in the chronic hemodialysis population, accounting for over 25% of hospitalizations at an estimated cost in the US of at least one billion dollars annually. Currently, complication free survival of vascular access ranges between 30-50% a year and multiple investigative efforts in this area have been initiated and are directed at prolonging the functional life of vascular accesses.
It is not well established whether intervention prior to overt malfunction or thrombosis of the vascular access could reduce these complications and thereby improve the functional longevity of the access. Moreover, once accesses at potential risk are identified, it is not well established which method of intervention, Surgery vs. Angioplasty vs. Expectant Management, is superior in terms of clinical and financial outcome. The proposed study aims to determine whether early intervention of a vascular access determined to be at risk of malfunction and thrombosis improves the long term outcome and, specifically, which means of intervention is preferred.
| Condition | Intervention | Phase |
|---|---|---|
|
End-Stage Renal Disease |
Procedure: angioplasty Procedure: surgery |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment |
| Official Title: | Prevention and Treatment of Hemodialysis Vascular Access Malfunction |
| Enrollment: | 0 |
| Study Start Date: | May 1998 |
| Study Completion Date: | October 2006 |
| Primary Completion Date: | October 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: No Intervention
control group
|
|
|
2: Active Comparator
angioplasty intervention
|
Procedure: angioplasty
angioplasty performed at the time of the angiogram; approach and technique to be determined by the interventional radiologist
|
|
3: Active Comparator
surgery intervention
|
Procedure: surgery
surgical revision of patient's PTFE in a timely fashion not to exceed 72-96 hours after the angiogram; method of revision to be determined by the surgeon performing the procedure
|
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Tennessee | |
| Vanderbilt University Medical Center | |
| Nashville, Tennessee, United States, 37232 | |
| Principal Investigator: | Talat A Ikizler, MD | Vanderbilt University |
More Information
| Responsible Party: | Vanderbilt University Medical Center ( Alp Ikizler, MD ) |
| Study ID Numbers: | 9318 |
| Study First Received: | September 13, 2005 |
| Last Updated: | December 19, 2007 |
| ClinicalTrials.gov Identifier: | NCT00179192 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
End Stage Renal Disease ESRD Chronic Maintenance Hemodialysis |
|
Renal Insufficiency Urologic Diseases Renal Insufficiency, Chronic |
Kidney Failure, Chronic Kidney Diseases Kidney Failure |