ACCESS HD
Research type
Research Study
Full title
Comparing Catheters to Fistulas in Elderly Patients Starting Hemodialysis (ACCESS HD)
IRAS ID
270738
Contact name
Damien Ashby
Contact email
Sponsor organisation
University of Calgary
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
NHS England reports that there are 1.8 million people in England with a diagnosis of Chronic Kidney Disease (stages 3-5), and this number is expected to double by 2040. Those with stage 5 Chronic Kidney Disease require dialysis or a transplant to improve survival.
The choice of vascular access for people treated with hemodialysis is an important intervention question. However, only observational studies are available to inform decision-making in this area and they are at high risk of bias. While a clinical trial comparing the impact of the two most frequently chosen strategies for vascular access in the hemodialysis population (fistulas and catheters) on hard clinical endpoints is needed, the feasibility of such a trial is unknown. This pilot randomized controlled trial (RCT) will test the feasibility and safety of randomizing elderly people who start hemodialysis with a central venous catheter, and are eligible to receive a fistula attempt, to continued use of catheters (comparator) or to receive an attempt at fistula creation (intervention). The primary outcome will be feasibility, which we will assess by measuring 1) the proportion of participants deemed eligible for the trial who will consent to randomization and 2) the proportion of participants randomized to the intervention who will receive the fistula attempt within 90 days of randomization. Secondary outcomes will include safety, the reasons people and health care providers may not accept randomization, and the reasons sites may not adhere to the trial protocol. The results of the pilot RCT will be published and we will collect data necessary to inform the design of a large RCT powered for a primary outcome of all-cause mortality.
REC name
London - Brent Research Ethics Committee
REC reference
19/LO/1547
Date of REC Opinion
21 Nov 2019
REC opinion
Further Information Favourable Opinion