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Trial of Fistula Versus Graft in Elderly Patients

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ClinicalTrials.gov Identifier: NCT03668002
Recruitment Status : Recruiting
First Posted : September 12, 2018
Last Update Posted : October 9, 2020
Sponsor:
Information provided by (Responsible Party):
Theodore Yuo, University of Pittsburgh

Brief Summary:
This open-label pilot randomized controlled trial will test the feasibility and safety of randomizing patients over 65 years old who start hemodialysis with a tunneled dialysis catheter (TDC), and are eligible to receive either arteriovenous fistula (AVF) or arteriovenous graft (AVG), to an AVF strategy (comparator) or to an AVG strategy (intervention). The primary outcome is feasibility, which we will assess by measuring: (1) the proportion of randomized participants who receive the assigned arteriovenous access; and (2) the annual rate of enrollment in the study, accounting for the number of surgeons who participate. Secondary outcomes will include perioperative morbidity and mortality, catheter removal rates, additional procedures performed, and the reasons a patient may not receive the assigned AV access.

Condition or disease Intervention/treatment Phase
End Stage Renal Disease Arteriovenous Fistula Arteriovenous Graft Procedure: Arteriovenous Fistula (AVF) Procedure: Arteriovenous Graft (AVG) Not Applicable

Detailed Description:

End-stage renal disease requiring dialysis affects approximately 400,000 patients in the United States with 100,000 new patients starting dialysis annually. The vast majority of those patients utilize hemodialysis (HD), and of that group, approximately 80% start with a tunneled dialysis catheter (TDC). Current guidelines discourage TDC, due to the risk of serious complications like bloodstream infections, central venous stenosis, and an associated increased mortality risk. The preferred alternative is an arteriovenous (AV) access, either native arteriovenous fistulas (AVF) or prosthetic arteriovenous grafts (AVG). AVF are considered the ideal long-term vascular access due to longer patency, lower costs, and an association with longer survival as compared to AVG when they successfully mature. However, AVF frequently require many months to mature after being constructed and have high primary failure rates (i.e., inability to be used without revision); AVG typically perform better short term, enabling early TDC removal and reduction in catheter related harms, but higher rates of failure and complications long term.

In older populations, multiple studies have suggested that the elderly population may not benefit from AVF as opposed to AVG, due to high AVF primary failure rates and overall abbreviated life expectancy that minimizes any possible long-term benefit with AVF.

METHODS AND ANALYSIS: This open-label pilot randomized controlled trial will test the feasibility and safety of randomizing patients over 65 years old who start hemodialysis with a TDC (the most common initial type of HD access), and are eligible to receive either AVF or AVG, to an AVF strategy (comparator) or to an AVG strategy (intervention). We will enroll 50 patients. Participants will provide informed consent, and they will be assigned to the AVF or AVG arms. The primary outcome is feasibility, which we will assess by measuring: (1) the annual rate of enrollment in the study, accounting for the number of surgeons who participate; and (2) the proportion of randomized participants who receive the assigned AV access. Secondary outcomes will include perioperative morbidity and mortality, catheter removal rates, additional procedures performed, and the reasons a patient may not receive the assigned AV access after randomization.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This study will provide preliminary data and possibly demonstrate feasibility of a large scale randomized controlled trial comparing AVF and AVG in elderly patients (defined as patients over 65 years of age) receiving hemodialysis through a TDC.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Trial of Fistula Versus Graft in Elderly Patients Pilot Study (RIGEL Pilot)
Actual Study Start Date : September 14, 2018
Estimated Primary Completion Date : August 31, 2021
Estimated Study Completion Date : August 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas

Arm Intervention/treatment
Placebo Comparator: Arteriovenous Fistula (AVF)
If the participant is randomized to the AVF arm of the trial, the surgeon will connect an artery to a vein in the upper extremity, without using artificial material as conduit.
Procedure: Arteriovenous Fistula (AVF)
If the participant is randomized to the AVF arm of the trial, the surgeon will connect an artery to a vein in the upper extremity, without using artificial material as conduit.

Active Comparator: Arteriovenous Graft (AVG)
If the participant is randomized to the AVG arm of the trial, the surgeon will place a synthetic graft connecting an artery and vein under the skin in an upper extremity.
Procedure: Arteriovenous Graft (AVG)
If the participant is randomized to the AVG arm of the trial, the surgeon will place a synthetic graft connecting an artery and vein under the skin in an upper extremity.




Primary Outcome Measures :
  1. Proportion of subjects that received assigned AV access (AVF vs. AVG) [ Time Frame: 12 months ]
    Adherence to assigned AV access (AVF vs. AVG) during randomization will be measured, expressed as a proportion of all subjects randomized.


Secondary Outcome Measures :
  1. Rate of accrual of subjects to the study [ Time Frame: 12 months ]
    Rate of subjects successfully randomized, expressed as subjects per year per surgeon.



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age greater than 65 years old.
  • On hemodialysis through a tunneled dialysis catheter.
  • In the surgeon's opinion, both a fistula and a graft can be reasonably attempted, based on the patient's anatomy.

Exclusion Criteria:

  • Unable to provide informed consent.
  • Unable to be medically cleared for surgery
  • Does not wish to have surgery.
  • Does not wish to be randomized.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03668002


Contacts
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Contact: Judith Brimmeier, BSN, RN 412-623-8486 brimmeierja@upmc.edu
Contact: Julianna Sheline, BS, RN 412-235-1304 shelinej@upmc.edu

Locations
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United States, Pennsylvania
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Theodore Yuo, MD    412-802-3028    yuoth@upmc.edu   
Contact: Judith Brimmeier, BSN RN    4126238486    brimmeierja@upmc.edu   
Sponsors and Collaborators
University of Pittsburgh
Investigators
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Principal Investigator: Theodore Yuo, MD MSc University of Pittsburgh
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Responsible Party: Theodore Yuo, Assistant Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT03668002    
Other Study ID Numbers: PRO17100473
First Posted: September 12, 2018    Key Record Dates
Last Update Posted: October 9, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Theodore Yuo, University of Pittsburgh:
Fistula vs. Graft
Additional relevant MeSH terms:
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Kidney Failure, Chronic
Arteriovenous Fistula
Fistula
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Pathological Conditions, Anatomical
Arteriovenous Malformations
Vascular Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases
Vascular Fistula
Vascular Diseases
Congenital Abnormalities