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| Descriptive Information Fields | |||||
| Brief Title † | Prevention and Treatment of Hemodialysis Vascular Access Malfunction | ||||
| Official Title † | Prevention and Treatment of Hemodialysis Vascular Access Malfunction | ||||
| Brief Summary | 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. |
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| Detailed Description | |||||
| Study Phase | Phase II | ||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Randomized, Open Label, Active Control, Parallel Assignment | ||||
| Primary Outcome Measure † | To test the hypothesis that early intervention of a vascular access determined to be at increased risk of malfunction and thrombosis improves the long-term access outcome versus standard of care. [ Time Frame: 2 years ] [ Designated as safety issue: No ] | ||||
| Secondary Outcome Measure † | To determine which means of early intervention, surgery versus angioplasty, is medically and financially advantageous. [ Time Frame: 2 years ] [ Designated as safety issue: No ] | ||||
| Condition † | End-Stage Renal Disease | ||||
| Intervention † | Procedure: angioplasty Procedure: surgery |
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| MEDLINE PMIDs | |||||
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| Recruitment Information Fields | |||||
| Recruitment Status † | Terminated | ||||
| Enrollment † | 0 | ||||
| Start Date † | May 1998 | ||||
| Completion Date | October 2006 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 85 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† | |||||
| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00179192 | ||||
| Organization ID | 9318 | ||||
| Secondary IDs †† | |||||
| Study Sponsor † | Vanderbilt University | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | Vanderbilt University | ||||
| Verification Date | December 2007 | ||||
| First Received Date † | September 13, 2005 | ||||
| Last Updated Date | December 19, 2007 | ||||