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Trial of Fistula Versus Graft in Elderly Patients
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 sponsor | University of Pittsburgh |
|---|---|
| Phase | NA |
| Status | TERMINATED |
| Enrolment | 21 |
| Start date | Fri Sep 14 2018 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Mon Aug 07 2023 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- End Stage Renal Disease
- Arteriovenous Fistula
- Arteriovenous Graft
Interventions
- Arteriovenous Fistula (AVF)
- Arteriovenous Graft (AVG)
Countries
United States