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

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) com...

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Bibliographic Details
Published in:BMJ open 2021-12, Vol.11 (12), p.e052188
Main Authors: Macfarlane, Alan JR, Kearns, Rachel J, Clancy, Marc James, Kingsmore, David, Stevenson, Karen, Jackson, Andrew, Mark, Patrick, Aitken, Margaret, Moonesinghe, Ramani, Vindrola-Padros, Cecilia, Gaianu, Lucian, Pettigrew, Gavin, Motallebzadeh, Reza, Karydis, Nikolaos, Vesey, Alex, Singh, Rita, Muniraju, Thalakunte, Suttie, Stuart, McConnachie, Alex, Wetherall, Kirsty, El-Boghdadly, Kariem, Hogg, Rosemary, Thomson, Iain, Nangalia, Vishal, Aitken, Emma, Lagaac, Regin, Hogg, Rosie, Dalton, Andrew, Bell, Samira, Ross, Rose, McNair, David, Stiff, Linda, Jardine, Catherine, Dosani, Mohammed Tariq, Sainsbury, Jennifer, Sran, Kiran, Castrillo, Nadia, Gilbert, James, Sinha, Sanjay, Sutherland, Sheera, Crosbie, Sarah, Gavrila, Madita, Montgomery, Sandra, McLennan, Tina, Tarkowska, Nina, Oliver, Scott, Brown, Liz, McLachlan, Shelley, Siqueira, Jonathan de, Troxler, Max, Dewhirst, Nikki, Wright, Mark, Srinath, Chetan, Bennett, Philip, Morrow, Darren, Clancy, Marc, Deelchand, Vashist, Badhan, Rani, Sivaprakasam, Rajesh, TimEgan, Gareth Ackland, Wikner, Matt, Macfarlane, Alan, Kearns, Rachel, MacConnachie, Alex, Moonsinghe, Ramani, Vindrola, Cecilia
Format: Article
Language:English
Subjects:
adult anaesthesia
Anaesthesia
Anesthesia, Local
Anticoagulants
Arteriovenous Fistula - surgery
Arteriovenous Shunt, Surgical
Contraindications
Cost analysis
Cost control
end-stage renal failure
Fistula
Hemodialysis
Humans
Kidney diseases
Kidney Failure, Chronic
Local anesthesia
Multicenter Studies as Topic
Patients
Quality of life
Randomized Controlled Trials as Topic
Regional anesthesia
Renal Dialysis - methods
Retrospective Studies
transplant surgery
Treatment Outcome
Ultrasonic imaging
Vascular Patency
vascular surgery
Veins & arteries
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Summary: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.
ISSN:2044-6055
2044-6055
DOI:10.1136/bmjopen-2021-052188