TY - JOUR
T1 - Anaesthesia Choice for Creation of Arteriovenous Fistula (ACCess) study protocol
T2 - 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
AU - Mark, Patrick
AU - Aitken, Margaret
AU - Moonesinghe, 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 - © Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ.
PY - 2021/12/22
Y1 - 2021/12/22
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.
U2 - 10.1136/bmjopen-2021-052188
DO - 10.1136/bmjopen-2021-052188
M3 - Article
C2 - 34937718
SN - 2044-6055
VL - 11
JO - BMJ Open
JF - BMJ Open
IS - 12
M1 - e052188
ER -