Rethinking Access for Dialysis in Older People (RADOP) Study
Research type
Research Study
Full title
Optimal Vascular Access for Elderly Haemodialysis Patients: a randomised controlled study comparing tunnelled haemodialysis catheters and native arteriovenous fistulae
IRAS ID
256787
Contact name
Becky Ward
Contact email
Sponsor organisation
Joint research Compliance Office
Duration of Study in the UK
1 years, 0 months, 2 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.
Haemodialysis is a form of bloodstream purification and haemodialysis "access" is the device used to connect a patient's blood to the machine (normal veins cannot be used since a faster blood flow is needed). Haemodialysis patients connect to the dialysis machine through one of two types of access, a line or a fistula. There are pros and cons for each, but since fistula patients generally fare better, national guidelines strongly promote fistulas over lines for all patients.
In older patients, the advantages of fistula formation are marginal at most. Fistula formation is time consuming, less successful, and occasionally even harmful. For the growing population of older dialysis patients, the national guideline advice may be incorrect.
Our hypothesis is that for the elderly patient approaching dialysis, planning a line rather than a fistula, would reduce treatment burden and improve quality of life, without any clinical disadvantage. This project would be a pilot study, to resolve design issues and provide initial data for a larger study. We would recruit 52 patients who are over 70 and approaching dialysis, and randomise them to a line or fistula with 12-month follow up. The primary outcome would be drop-out rate, with secondary outcomes including other design issues and quality of life measurements.
Results of this study will facilitate design and funding application for a multicentre randomised study to involve approximately 550 patients.
REC name
Wales REC 7
REC reference
19/WA/0077
Date of REC Opinion
10 Apr 2019
REC opinion
Further Information Favourable Opinion