Prevention and Treatment of Hemodialysis Vascular Access Malfunction

Phase 2

Withdrawn

• Conditions: End-Stage Renal Disease
• Interventions: Procedure: angioplasty; Procedure: surgery

• Registration Number: NCT00179192
• Lead Sponsor: Vanderbilt University

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

Not available

Study Timeline

• Study Start: 1998-05
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-15
• Primary Completion: 2006-10
• Study Completion: 2006-10
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-21
• Last Update Posted: 2015-05-25

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	angioplasty	angioplasty intervention
3	surgery	surgery intervention

Primary Outcome Measures

Name	Time	Method
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.	2 years

Secondary Outcome Measures

Name	Time	Method
To determine which means of early intervention, surgery versus angioplasty, is medically and financially advantageous.	2 years

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States