Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT03668002 |
| Other study ID # |
PRO17100473 |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 14, 2018 |
| Est. completion date |
August 7, 2023 |
Study information
| Verified date |
August 2023 |
| Source |
University of Pittsburgh |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
