RT Journal Article
SR Electronic
T1 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
JF BMJ Open
JO BMJ Open
FD British Medical Journal Publishing Group
SP e052188
DO 10.1136/bmjopen-2021-052188
VO 11
IS 12
A1 Alan JR Macfarlane
A1 Rachel J Kearns
A1 Marc James Clancy
A1 David Kingsmore
A1 Karen Stevenson
A1 Andrew Jackson
A1 Patrick Mark
A1 Margaret Aitken
A1 Ramani Moonesinghe
A1 Cecilia Vindrola-Padros
A1 Lucian Gaianu
A1 Gavin Pettigrew
A1 Reza Motallebzadeh
A1 Nikolaos Karydis
A1 Alex Vesey
A1 Rita Singh
A1 Thalakunte Muniraju
A1 Stuart Suttie
A1 Alex McConnachie
A1 Kirsty Wetherall
A1 Kariem El-Boghdadly
A1 Rosemary Hogg
A1 Iain Thomson
A1 Vishal Nangalia
A1 Emma Aitken
A1 ,
YR 2021
UL http://bmjopen.bmj.com/content/11/12/e052188.abstract
AB Introduction Arteriovenous 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 analysis The 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 dissemination The 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 number ISRCTN14153938.Sponsor NHS Greater Glasgow and Clyde GN19RE456, Protocol V.1.3 (8 May 2021), REC/IRAS ID: 290482.