Anaesthesia Choice for Creation of Arteriovenous Fistula (ACCess) study protocol : a randomised controlled trial comparing primary unassisted patency at 1 year of primary arteriovenous fistulae created under regional compared to local anaesthesia
Autor: | Alan Jr, Macfarlane, Rachel J, Kearns, Marc James, Clancy, David, Kingsmore, Karen, Stevenson, Andrew, Jackson, Patrick, Mark, Margaret, Aitken, Ramani, Moonesinghe, Cecilia, Vindrola-Padros, Lucian, Gaianu, Gavin, Pettigrew, Reza, Motallebzadeh, Nikolaos, Karydis, Alex, Vesey, Rita, Singh, Thalakunte, Muniraju, Stuart, Suttie, Alex, McConnachie, Kirsty, Wetherall, Kariem, El-Boghdadly, Rosemary, Hogg, Iain, Thomson, Vishal, Nangalia, Emma, Aitken, Cecilia, Vindrola |
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Rok vydání: | 2021 |
Předmět: |
General Medicine
vascular surgery Anaesthesia end-stage renal failure Arteriovenous Shunt Surgical Treatment Outcome Renal Dialysis transplant surgery Arteriovenous Fistula Humans Kidney Failure Chronic Multicenter Studies as Topic adult anaesthesia Vascular Patency Anesthesia Local Randomized Controlled Trials as Topic Retrospective Studies |
Zdroj: | BMJ Open |
ISSN: | 2044-6055 |
Popis: | IntroductionArteriovenous fistulae (AVF) are the ‘gold standard’ vascular access for haemodialysis. Universal usage is limited, however, by a high early failure rate. Several small, single-centre studies have demonstrated better early patency rates for AVF created under regional anaesthesia (RA) compared with local anaesthesia (LA). The mechanistic hypothesis is that the sympathetic blockade associated with RA causes vasodilatation and increased blood flow through the new AVF. Despite this, considerable variation in practice exists in the UK. A high-quality, adequately powered, multicentre randomised controlled trial (RCT) is required to definitively inform practice.Methods and analysisThe Anaesthesia Choice for Creation of Arteriovenous Fistula (ACCess) study is a multicentre, observer-blinded RCT comparing primary radiocephalic/brachiocephalic AVF created under regional versus LA. The primary outcome is primary unassisted AVF patency at 1 year. Access-specific (eg, stenosis/thrombosis), patient-specific (including health-related quality of life) and safety secondary outcomes will be evaluated. Health economic analysis will also be undertaken.Ethics and disseminationThe ACCess study has been approved by the West of Scotland Research and ethics committee number 3 (20/WS/0178). Results will be published in open-access peer-reviewed journals within 12 months of completion of the trial. We will also present our findings at key national and international renal and anaesthetic meetings, and support dissemination of trial outcomes via renal patient groups.Trial registration numberISRCTN14153938.SponsorNHS Greater Glasgow and Clyde GN19RE456, Protocol V.1.3 (8 May 2021), REC/IRAS ID: 290482. |
Databáze: | OpenAIRE |
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