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Prevention and Treatment of Hemodialysis Vascular Access Malfunction

This study has been terminated.
Study NCT00179192.   Last updated on December 19, 2007.   Information provided by Vanderbilt University

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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.

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
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Terminated
Enrollment  0
Start Date  May 1998
Completion Date October 2006
Eligibility Criteria 

Inclusion Criteria:

  1. Subjects with End Stage Renal Disease on chronic maintenance hemodialysis 3 times per week
  2. Have an arteriovenous (polytetrafluoroethylene) graft as vascular access
  3. Have a venous stenosis between 30% and 70% as determined by angiogram

Exclusion Criteria:

  1. Native arteriovenous fistula
  2. Known previous vascular accesses complications, such as central vein stenosis, and multiple access surgeries >4
  3. Unwilling to participate
  4. Allergy to iodine
  5. Absolute contraindication for surgery (e.g. medical condition precludes anesthesia and surgery)
  6. Known arterial limb stenosis or long vessel length venous stenosis which are unamenable to surgical or angioplasty techniques, respectively, and therefore prohibit randomization
  7. Known hypercoagulable state
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 
Principal Investigator:     Talat A Ikizler, MD     Vanderbilt University    
Information Provided By Vanderbilt University
Verification Date December 2007
First Received Date  September 13, 2005
Last Updated Date December 19, 2007

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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