Text Size

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
History of Changes
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prevention and Treatment of Hemodialysis Vascular Access Malfunction

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:
  • 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 Measures:
  • To determine which means of early intervention, surgery versus angioplasty, is medically and financially advantageous. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

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
No Intervention: 1
control group
Active Comparator: 2
angioplasty intervention
 Procedure: angioplasty
angioplasty performed at the time of the angiogram; approach and technique to be determined by the interventional radiologist
Active Comparator: 3
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
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00179192

Locations
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Sponsors and Collaborators
Vanderbilt University
Investigators
Principal Investigator: Talat A Ikizler, MD Vanderbilt University
  More Information

No publications provided

Responsible Party: Alp Ikizler, MD, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT00179192     History of Changes
Other Study ID Numbers: 9318
Study First Received: September 13, 2005
Last Updated: December 19, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
End Stage Renal Disease
ESRD
Chronic Maintenance Hemodialysis

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency

ClinicalTrials.gov processed this record on May 22, 2013