AF-CaT Feasibility
Research type
Research Study
Full title
A Mixed Methods Trial to Explore the Feasibility of Comparing Buttonhole to Rope Ladder Cannulation of Arteriovenous Fistulae for Haemodialysis
IRAS ID
274355
Contact name
Catherine Fielding
Contact email
Sponsor organisation
University Hospitals of Derby and Burton NHS Foundation Trust
ISRCTN Number
ISRCTN16275275
Duration of Study in the UK
1 years, 10 months, 8 days
Research summary
Patients with kidney failure require haemodialysis three times a week, for a period of years. An essential part of the treatment is the insertion of 2 needles into a specially formed arteriovenous fistula (aka 'fistula). The frequent needle insertions can damage the fistula, eventually causing it to fail. 2 techniques have been developed to reduce this damage - 'buttonhole' and 'rope ladder'. Previous studies have compared these 2 techniques, but obtained differing results. Systematic reviews recommend a multi-centre randomised controlled trial (RCT) to compare techniques.
This feasibility trial will explore the feasibility of a multi-centre RCT to compare buttonhole to rope ladder when used for haemodialysis. It will focus on whether fidelity of the needle insertion procedures is maintained to allow accurate comparison and whether proposed clinical outcomes are feasible, including patients' perspectives of the needle insertion.
The feasibility trial will be mixed methods, lasting 6 months, recruiting 40 patients at 2 sites. Participants will include haemodialysis patients with a fistula that has not yet had needles inserted for haemodialysis. Each patient will be randomised to either buttonhole or rope ladder and undergo this technique for routine haemodialysis treatments, for 6 months. They will complete a monthly questionnaire to capture their perspective of the needle insertion and may have the needle insertion procedure observed on selected occasions. Data will also be collected on complications, including the function of the fistula and infection. After 6 months, a selection of patients from both study arms will be asked to undertake an interview to describe their experience of having needles inserted for haemodialysis. Patient participants will also be asked to complete a questionnaire, with some invited for an interview, to explore experiences of being part of the study. Nursing participants will provide data to assess feasibility of the RCT through a questionnaire and focus groups.
REC name
East Midlands - Derby Research Ethics Committee
REC reference
20/EM/0001
Date of REC Opinion
13 Feb 2020
REC opinion
Further Information Favourable Opinion