Prevention and Treatment of Hemodialysis Vascular Access Malfunction - Full Text View

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 II

MedlinePlus related topics:

Angioplasty Dialysis Kidney Failure

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment

Official Title:	Prevention and Treatment of Hemodialysis Vascular Access Malfunction

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
1: No Intervention control group
2: Active Comparator angioplasty intervention	Procedure: angioplasty angioplasty performed at the time of the angiogram; approach and technique to be determined by the interventional radiologist
3: Active Comparator 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:

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

Exclusion Criteria:

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

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

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

Keywords provided by Vanderbilt University:

End Stage Renal Disease

ESRD

Chronic Maintenance Hemodialysis

Study placed in the following topic categories:

Renal Insufficiency

Urologic Diseases

Renal Insufficiency, Chronic

Kidney Failure, Chronic

Kidney Diseases

Kidney Failure

ClinicalTrials.gov processed this record on September 05, 2008

Sponsored by:	Vanderbilt University
Information provided by:	Vanderbilt University
ClinicalTrials.gov Identifier:	NCT00179192