Randomized Fistula Study - Full Text View

Sponsored by:	University of Pittsburgh
Information provided by:	University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT00808561

Purpose

The primary objective of this study is to compare two treatment strategies for establishing dialysis access in patients with unsuitable forearm veins for the standard forearm primary radio-cephalic arteriovenous fistula also known as the Brescia-Cimino fistula.

Condition	Intervention
Renal Failure	Other: Group 1: Alternative Fistula Other: Group 2: Forearm AV Graft

MedlinePlus related topics: Fistulas

Drug Information available for: Polytetrafluoroethylene Benzocaine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study
Official Title:	Prospective Randomized Trial of Fistula vs. Forearm AV Graft in Patients With Poor Venous Access; Protocol #3, Version 1

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:

The primary endpoint will be the rate of composite adverse events at one year with follow-up to 3 years. Data will be tabulated every 6 months. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Secondary endpoints: Primary, assisted primary, and secondary patency at 1 and 3 years [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
Death due to access-related illness [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
Death due to any cause [ Time Frame: 3 Years ] [ Designated as safety issue: Yes ]
New central venous stenosis or occlusion [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
Steal syndrome [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
Neuropathy [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	180
Study Start Date:	December 2008
Estimated Study Completion Date:	January 2013
Estimated Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 Alternative Fistula: Active Comparator	Other: Group 1: Alternative Fistula Performing other autogenous AV fistulas which include various options such as brachiocephalic AV fistula, basilic or brachial vein transpositions or a variety of other strategies to maintain a primary access. The advantage would be to maintain an autogenous all venous access with less risk of infection and thrombosis.
2 Forearm AV Graft: Active Comparator	Other: Group 2: Forearm AV Graft a) ePTFE (polytetrafluoroethylene) bridge AV graft typically anastomosed in the proximal forearm to the radial or brachial artery and to an antecubital vein. The advantages include a quick maturation of 2-3 weeks, excellent flow rates and high technical success rates. Although secondary patency rates approach 80% at one year postoperatively, disadvantages include a more involved surgical procedure, a lower primary patency than a well functioning AV fistula, and higher revision and infection rates.4, 5

Arms

Assigned Interventions

1 Alternative Fistula: Active Comparator

Other: Group 1: Alternative Fistula

Performing other autogenous AV fistulas which include various options such as brachiocephalic AV fistula, basilic or brachial vein transpositions or a variety of other strategies to maintain a primary access. The advantage would be to maintain an autogenous all venous access with less risk of infection and thrombosis.

2 Forearm AV Graft: Active Comparator

Other: Group 2: Forearm AV Graft

a) ePTFE (polytetrafluoroethylene) bridge AV graft typically anastomosed in the proximal forearm to the radial or brachial artery and to an antecubital vein. The advantages include a quick maturation of 2-3 weeks, excellent flow rates and high technical success rates. Although secondary patency rates approach 80% at one year postoperatively, disadvantages include a more involved surgical procedure, a lower primary patency than a well functioning AV fistula, and higher revision and infection rates.4, 5

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

To participate in this study, the subject MUST have all of the following for inclusion in the study:

The subject must be > 18 years of age, male or female
Subject requires creation of dialysis access secondary to ESRD in the opinion of the referring nephrologist
Target arm may have a failed radiocephalic fistula
Contralateral failed or failing access may exist
The subject must sign a written informed consent, prior to the procedure, using a form that is approved by the local Institutional Review Board.

Exclusion Criteria:

To participate in this study, the subject may NOT HAVE any of the following at enrollment to the study:

Target arm has existing forearm AV graft, either functional or non-functional
Target arm has existing fistula, either functional or non-functional, other than a radio-cephalic at the wrist
Target arm has documented subclavian vein occlusion
Target arm has obviously suitable cephalic vein and radial artery for a primary radiocephalic fistula
Target arm has no superficial veins existing as options for primary access. If so, a second surgeon will review the ultrasound to confirm
Active local or systemic infection at the time of surgery
Known hypercoagulable state (e.g., antithrombin III deficiency, antiphospholipid or anticardiolipin antibodies, Factor IV Leiden, circulating lupus anticoagulant, history of heparin-induced thrombocytopenia, Protein C or S deficiency, prothrombin mutation or a history of recurrent deep venous thrombosis and/or pulmonary embolism)
Disseminated malignancy or other terminal condition where subject is expected to live less than 6 months.
Previous randomization in this trial

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00808561

Contacts

Contact: Suzanne C David, RN, MPH	412-623-8443	davids@upmc.edu
Contact: Judi Brimmeier A Brimmeier, RN, BSN	412-235-1304	brimmeierj@upmc.edu

Locations

United States, Pennsylvania
University of Pittsburgh Medical Center	Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Suzanne C David, RN, MPH 412-623-8443 davids@upmc.edu
Contact: Judi Brimmeier, RN, BSN 412-235-1304 brimmeierj@upmc.edu
Principal Investigator: Navyash Gupta, MD

Sponsors and Collaborators

University of Pittsburgh

Investigators

Principal Investigator:

Navyash Gupta, MD

University of Pittsburgh Physicians

More Information

Responsible Party:	University of Pittsburgh Physicians ( Navyash Gupta, MD )
Study ID Numbers:	Protocol #3, V1, Fistula
Study First Received:	December 12, 2008
Last Updated:	December 15, 2008
ClinicalTrials.gov Identifier:	NCT00808561
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Renal Insufficiency
Urologic Diseases
Benzocaine

Kidney Diseases
Fistula
Kidney Failure

ClinicalTrials.gov processed this record on January 14, 2009