Randomized Fistula Study

This study has been terminated.
(Slow enrollment due to multiple screen failures)
Sponsor:
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00808561
First received: December 12, 2008
Last updated: February 11, 2010
Last verified: February 2010
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Randomized Trial of Fistula vs. Forearm AV Graft in Patients With Poor Venous Access; Protocol #3, Version 1

Resource links provided by NLM:


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
Active Comparator: 1 Alternative Fistula 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.
Active Comparator: 2 Forearm AV Graft 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

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  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15232
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Navyash Gupta, MD University of Pittsburgh Physicians
  More Information

No publications provided

Responsible Party: Navyash Gupta, MD, University of Pittsburgh Physicians
ClinicalTrials.gov Identifier: NCT00808561     History of Changes
Other Study ID Numbers: Protocol #3, V1, Fistula
Study First Received: December 12, 2008
Last Updated: February 11, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on August 21, 2014