Trial of Fistula Versus Graft in Elderly Patients

NCT ID: NCT03668002

Last Updated: 2023-08-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-14
• Study Completion Date: 2023-08-07

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.

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.

Conditions

End Stage Renal Disease; Arteriovenous Fistula; Arteriovenous Graft

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: PLACEBO_COMPARATOR

Arteriovenous Fistula (AVF)

Intervention Type: PROCEDURE

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.

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.

Group Type: ACTIVE_COMPARATOR

Arteriovenous Graft (AVG)

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility 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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Theodore Yuo

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Theodore Yuo, MD MSc

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Countries

United States

Other Identifiers

PRO17100473

Identifier Type: -

Identifier Source: org_study_id