Prevention and Treatment of Hemodialysis Vascular Access Malfunction

NCT ID: NCT00179192

Last Updated: 2015-05-25

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 1998-05-31
• Study Completion Date: 2006-10-31

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.

Conditions

End-Stage Renal Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

control group

Group Type: NO_INTERVENTION

No interventions assigned to this group

2

angioplasty intervention

Group Type: ACTIVE_COMPARATOR

angioplasty

Intervention Type: PROCEDURE

angioplasty performed at the time of the angiogram; approach and technique to be determined by the interventional radiologist

3

surgery intervention

Group Type: ACTIVE_COMPARATOR

surgery

Intervention Type: PROCEDURE

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

Interventions

angioplasty

angioplasty performed at the time of the angiogram; approach and technique to be determined by the interventional radiologist

Intervention Type: 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

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vanderbilt University

OTHER

Sponsor Role: lead

Responsible Party

Alp Ikizler

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Talat A Ikizler, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Countries

United States

Other Identifiers

9318

Identifier Type: -

Identifier Source: org_study_id