Clinical trial NCT03668002: Trial of Fistula Versus Graft in Elderly Patients
Official title: Randomized Trial of Fistula Versus Graft in Elderly Patients Pilot Study (RIGEL Pilot)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: End Stage Renal Disease
Arteriovenous Fistula
Arteriovenous Graft
Keywords: Fistula vs. Graft
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2018-09-12
Enrollment: 21
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Proportion of subjects that received assigned AV access (AVF vs. AVG)
timeFrame: 12 months
Secondary outcomes:
measure: Rate of accrual of subjects to the study
timeFrame: 12 months
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Theodore Yuo, MD MSc
role: PRINCIPAL_INVESTIGATOR
References: