TY - JOUR
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
AU - Macfarlane, Alan J. R.
AU - Kearns, Rachel J.
AU - Clancy, Marc James
AU - Kingsmore, David
AU - Stevenson, Karen
AU - Jackson, Andrew P.
AU - Mark, Patrick
AU - Aitken, Margaret
AU - Moonesinghe, Suneetha Ramani
AU - Vindrola-Padros, Cecilia
AU - Gaianu, Lucian
AU - Pettigrew, Gavin
AU - Motallebzadeh, Reza
AU - Karydis, Nikolaos
AU - Vesey, Alex
AU - Singh, Rita
AU - Muniraju, Thalakunte
AU - Suttie, Stuart
AU - McConnachie, Alex
AU - Wetherall, Kirsty
AU - El-Boghdadly, Kariem
AU - Hogg, Rosemary
AU - Thomson, Iain
AU - Nangalia, Vishal
AU - Aitken, Emma
N1 - Funding Information:
Funding This work is supported by National Institute for Health Research (NIHR) (Health Technology Assessment 130 567). The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care.
Publisher Copyright:
©
PY - 2021/12
Y1 - 2021/12
N2 - 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.
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.
UR - http://www.scopus.com/inward/record.url?scp=85122396559&partnerID=8YFLogxK
U2 - 10.1136/bmjopen-2021-052188
DO - 10.1136/bmjopen-2021-052188
M3 - Article
SN - 2044-6055
VL - 11
JO - BMJ Open
JF - BMJ Open
IS - 12
M1 - e052188
ER -