Prevention and Treatment of Hemodialysis Vascular Access Malfunction

This study has been terminated.
(non-enrollment)
Sponsor:
Information provided by:
Vanderbilt University
ClinicalTrials.gov Identifier:
NCT00179192
First received: September 13, 2005
Last updated: December 19, 2007
Last verified: December 2007

September 13, 2005
December 19, 2007
May 1998
October 2006   (final data collection date for 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 ]
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.
Complete list of historical versions of study NCT00179192 on ClinicalTrials.gov Archive Site
To determine which means of early intervention, surgery versus angioplasty, is medically and financially advantageous. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
To determine which means of early intervention, surgery versus angioplasty, is medically and financially advantageous.
Not Provided
Not Provided
 
Prevention and Treatment of Hemodialysis Vascular Access Malfunction
Prevention and Treatment of Hemodialysis Vascular Access Malfunction

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
End-Stage Renal Disease
  • Procedure: angioplasty
    angioplasty performed at the time of the angiogram; approach and technique to be determined by the interventional radiologist
  • 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
  • No Intervention: 1
    control group
  • Active Comparator: 2
    angioplasty intervention
    Intervention: Procedure: angioplasty
  • Active Comparator: 3
    surgery intervention
    Intervention: Procedure: surgery
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
0
October 2006
October 2006   (final data collection date for primary outcome measure)

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
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00179192
9318
No
Alp Ikizler, MD, Vanderbilt University Medical Center
Vanderbilt University
Not Provided
Principal Investigator: Talat A Ikizler, MD Vanderbilt University
Vanderbilt University
December 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP