Cardiorespiratory Optimisation By Arteriovenous fistula Ligation after renal Transplantation (COBALT): study protocol for a multicentre randomised interventional feasibility trial.

Autor:	Surendrakumar V; Department of Thoracic Surgery, University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.; Department of Surgery, University of Cambridge, Cambridge, UK., Aitken E; Department of Renal Surgery, Queen Elizabeth University Hospital, Glasgow, UK.; Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK., Mark P; Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, UK., Motallebzadeh R; Department of Nephrology and Transplantation, Royal Free London NHS Foundation Trust, London, UK.; Division of Surgery and Interventional Science, University College London, London, UK., Hunter J; Department of Transplant and Dialysis Access Surgery, University Hospitals Coventry and Warwickshire NHS Trust, Coventry, UK.; Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK., Amer A; Institute of Transplantation, Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle Upon Tyne, UK., Summers D; Department of Surgery, University of Cambridge, Cambridge, UK.; Department of Transplant Surgery, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK., Rennie K; MRC Epidemiology Unit, University of Cambridge, Cambridge, UK., Rooshenas L; Bristol Population Health Science Institute, University of Bristol, Bristol, UK., Garbi M; Department of Cardiology, Royal Papworth Hospital NHS Foundation Trust, Cambridge, UK., Sylvester K; Respiratory Physiology Services, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK., Hudson C; Statistics and Clinical Studies, NHS Blood and Transplant Organ Donation and Transplantation Directorate, Bristol, UK., Banks J; Statistics and Clinical Studies, NHS Blood and Transplant Organ Donation and Transplantation Directorate, Bristol, UK., Sidders A; Clinical Trials Unit, NHSBT Clinical Trials Unit, Cambridge, UK., Norton A; Addenbrooke's Kidney Patients Association, Cambridge, UK., Slater M; Department of Transplant Surgery, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK., Bartlett M; Vascular Studies, Royal Free London NHS Foundation Trust, London, UK., Knight S; Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK., Pettigrew G; Department of Surgery, University of Cambridge, Cambridge, UK gjp25@cam.ac.uk.; Department of Transplant Surgery, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.
Jazyk:	angličtina
Zdroj:	BMJ open [BMJ Open] 2023 Feb 09; Vol. 13 (2), pp. e067668. Date of Electronic Publication: 2023 Feb 09.
DOI:	10.1136/bmjopen-2022-067668
Abstrakt:	Introduction: Cardiovascular events are a major cause of mortality following successful kidney transplantation.Arteriovenous fistulas (AVFs) are considered the best option for haemodialysis, but may contribute to this excess mortality because they promote adverse cardiac remodelling and ventricular hypertrophy. This raises the question whether recipients with a well-functioning kidney transplant should undergo elective AVF ligation. Methods and Analysis: The COBALT feasibility study is a multicentre interventional randomised controlled trial (RCT) that will randomise renal transplant patients with stable graft function and a working AVF on a 1:1 basis to standard care (continued conservative management) or to AVF ligation. All patients will perform cardiopulmonary exercise testing (CPET) on recruitment and 6 months later. Daily functioning and quality of life will be additionally assessed by questionnaire completion and objective measure of physical activity. The primary outcome-the proportion of approached patients who complete the study (incorporating rates of consent, receipt of allocated intervention and completion of both CPETs without withdrawal)-will determine progression to a full-scale RCT. Design of the proposed RCT will be informed by an embedded qualitative assessment of participant and healthcare professional involvement. Ethics and Dissemination: This study has been approved by the East Midlands-Derby Research Ethics Committee (22/EM/0002) and the Health Research Authority. The results of this work will be disseminated academically through presentation at national and international renal meetings and via open access, peer-reviewed outputs. Existing networks of renal patient groups will also be used to disseminate the study findings to other key stakeholders. Trial Registration Number: ISRCTN49033491. Competing Interests: Competing interests: None declared. (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY. Published by BMJ.)
Databáze:	MEDLINE
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