Introduction The selection of the type of vascular access for haemodialysis 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 selection bias. While a clinical trial comparing the effects of the 2 most frequently chosen strategies for haemodialysis access (fistulas and catheters) on patient important and ‘hard’ clinical end points is needed, the feasibility of such a trial is uncertain.
Methods and analysis This open-label pilot randomised controlled trial will test the feasibility and safety of randomising elderly people (≥65 years) who start haemodialysis with a central venous catheter (the most common initial type of haemodialysis access), and are eligible to receive a fistula, to a catheter-based strategy (comparator) or to a fistula-based strategy (intervention). We will enrol 100 patients at 10 centres across Canada. Participants assigned to the catheter-strategy arm will continue to use catheters; participants assigned to the fistula-strategy arm will receive a surgical attempt at fistula creation. The inclusion criteria are designed to minimise the risk of protocol violation and attrition. The primary outcome is feasibility, which we will assess by measuring: (1) the proportion of participants deemed eligible for the trial who consent to randomisation; and (2) the proportion of participants randomised to the intervention who receive the fistula surgery within 90 days of randomisation. Secondary outcomes will include safety outcomes, the reasons people and healthcare providers may not accept randomisation, and the reasons sites may not adhere to the trial protocol.
Ethics and dissemination The Conjoint Health Research Ethics Board at the University of Calgary approved the study protocol. We will submit the results of this feasibility study in a peer-reviewed journal.
Trial registration number NCT02675569, Pre-results.
- Vascular access
- Kidney failure
- Arteriovenous fistula
- Central venous catheter
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Collaborator Applied Health Research Centre of St Michael's Hospital.
The ACCESS HD investigator team include: RQ: Libin Cardiovascular Institute of Alberta, Department of Medicine, and O'Brien Institute of Public Health, Department of Community Health Sciences, Cumming School of Medicine, University of Calgary; Jennifer MacRae: Libin Cardiovascular Institute of Alberta, Department of Medicine, Cumming School of Medicine, University of Calgary; Mauricio F Monroy-Cuadros: Division of Transplantation, Department of Surgery, Cumming School of Medicine, University of Calgary. Serdar Yilmaz: Division of Transplantation, Department of Surgery, Cumming School of Medicine, University of Calgary. Maria Santana: O'Brien Institute of Public Health (Department of Community Health Sciences), Cumming School of Medicine, University of Calgary; Matthew Oliver: Department of Medicine, Division of Nephrology Sunnybrook Health Science Centre, University of Toronto. Robert P Pauly: Division of Nephrology and Transplantation Immunology, University of Alberta. Sabin Shurraw: Division of Nephrology and Transplantation Immunology, University of Alberta. Lisa Miller: Max Rady College of Medicine, University of Manitoba. Clara Bohm: Section of Nephrology, Department of Medicine, Max Rady College of Medicine, University of Manitoba. Gihad Nesrallah: Li Ka Shing Knowledge Institute, St Michael's Hospital, University of Toronto. Michael Walsh: Departments of Medicine and Clinical Epidemiology and Biostatistics; Population Health Research Institute, Hamilton Health Sciences/McMaster University. Swapnil Hiremath: University of Ottawa, Faculty of Medicine and Ottawa Hospital Research Institute, Centre for Practice Changing Research. Janet Graham: The University of Ottawa, The Ottawa Hospital Research Institute. Brendan Barrett: Memorial University of Newfoundland, Patient Research Centre. Greg Browne: Clinical Chief, Division of Vascular Surgery, Eastern Health. Louise Moist: Department of Medicine, Schulich School of Medicine and Dentistry, and Kidney Clinical Research Unit, Western University. Ron Wald: Division of Nephrology, St Michael's Hospital and University of Toronto; Li Ka Shing Knowledge Institute of St Michael's Hospital. Kevin Thorpe: Dalla Lana School of Public Health, University of Toronto, and Applied Health Research Centre of the Li Ka Shing Knowledge Institute of St Michael's Hospital. Muhammad Mamdani: Li Ka Shing Centre for Healthcare Analytics Research and Training—St Michael's Hospital, University of Toronto—Department of Medicine, University of Toronto—Leslie Dan Faculty of Pharmacy, University of Toronto—Dalla Lana Faculty of Public Health, Institute for Clinical Evaluative Sciences. PR: Libin Cardiovascular Institute of Alberta, Department of Medicine, and O'Brien Institute of Public Health, Department of Community Health Sciences, Cumming School of Medicine, University of Calgary.
Contributors PR and RQ conceived the study, designed the trial, obtained funding for this pilot RCT from the Canadian Institute of Health Research (CIHR) and the Kidney Foundation of Canada (KFoC) and drafted the final study protocol and the present manuscript. All listed authors (principal investigators at each site and members of the coordinating centre team) provided critical feedback to the study protocol and the present manuscript, and approved the final versions of both.
Funding University of Calgary (in kind resources); KFoC (FRN KFOC150015) and CIHR (FRN 142342) funded the ACCESS HD pilot trial.
Disclaimer Neither the study sponsor (University of Calgary) nor the funding agencies had influence on the design and set-up of the trial, or write-up of the present manuscript.
Competing interests RQ is the coinventor of the Dialysis Measurement Analysis and Reporting System. Matthew Oliver is the coinventor of the Dialysis Measurement Analysis and Reporting System.
Ethics approval Conjoint Health Research Ethics Board at the University of Calgary.
Provenance and peer review Not commissioned; externally peer reviewed.
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