Prevention and Treatment of Hemodialysis Vascular Access Malfunction

NCT00179192 | Withdrawn Phase 2

• 1 other identifier: 9318
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Keywords

End Stage Renal Disease; ESRD; Chronic Maintenance Hemodialysis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• To determine which means of early intervention, surgery versus angioplasty, is medically and financially advantageous.

  2 years

Study Arms (3)

1

NO INTERVENTION

control group

2

ACTIVE COMPARATOR

angioplasty intervention

Procedure: angioplasty

3

ACTIVE COMPARATOR

surgery intervention

Procedure: surgery

Interventions

angioplasty PROCEDURE

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

2

surgery 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

3

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Native arteriovenous fistula
• Known previous vascular accesses complications, such as central vein stenosis, and multiple access surgeries \>4
• Unwilling to participate
• Allergy to iodine
• Absolute contraindication for surgery (e.g. medical condition precludes anesthesia and surgery)
• Known arterial limb stenosis or long vessel length venous stenosis which are unamenable to surgical or angioplasty techniques, respectively, and therefore prohibit randomization
• Known hypercoagulable state

Sponsors & Collaborators

• Vanderbilt University: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Angioplasty; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Minimally Invasive Surgical Procedures; Investigative Techniques

Study Officials

• Talat A Ikizler, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 15, 2005
• Study Start: May 1, 1998
• Primary Completion: October 1, 2006
• Study Completion: October 1, 2006
• Last Updated: May 25, 2015

Record last verified: 2015-05

Locations

US (1)