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Trial of Fistula Versus Graft in Elderly Patients

NCT03668002 NA TERMINATED

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.

Details

Lead sponsorUniversity of Pittsburgh
PhaseNA
StatusTERMINATED
Enrolment21
Start dateFri Sep 14 2018 00:00:00 GMT+0000 (Coordinated Universal Time)
CompletionMon Aug 07 2023 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

Interventions

Countries

United States