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Surgery
Protocol
Surveillance arterioveNous fistulAs using ultRasound (SONAR) trial in haemodialysis patients: a study protocol for a multicentre observational study
  1. James Richards1,2,
  2. Mohammed Hossain1,
  3. Dominic Summers1,2,
  4. Matthew Slater3,
  5. Matthew Bartlett4,
  6. Vasilis Kosmoliaptsis1,2,
  7. Edward CF Wilson5,
  8. Regin Lagaac6,
  9. Anna Sidders7,
  10. Claire Foley7,
  11. Emma Laing7,
  12. Valerie Hopkins7,
  13. Chloe Fitzpatrick-Creamer7,
  14. Cara Hudson7,
  15. Helen Thomas7,
  16. Sam Turner8,
  17. Andrew Tambyraja9,
  18. Subash Somalanka10,
  19. James Hunter11,
  20. Sam Dutta12,
  21. Sarah Lawman13,
  22. Tracey Salter10,14,
  23. Mohammed Aslam15,
  24. Atul Bagul16,
  25. Rajesh Sivaprakasam17,
  26. George Smith18,
  27. Zia Moinuddin19,
  28. Simon Knight20,
  29. Paul Gibbs21,
  30. Reza Motallebzadeh4,
  31. Nicholas Barnett22,
  32. Gavin Pettigrew1,2
  33. On behalf of the SONAR trial group
    1. 1 Department of Surgery, Addenbrooke’s Hospital, Cambridge, UK
    2. 2 Department of Surgery, Cambridge University, Cambridge, UK
    3. 3 Vascular Studies Unit, Addenbrooke’s Hospital, Cambridge, UK
    4. 4 Department of Nephrology and Renal Transplantation, Royal Free London NHS Foundation Trust, London, UK
    5. 5 Cambridge Centre for Health Services Research, University of Cambridge, Cambridge, UK
    6. 6 Cambridge Dialysis Centre, Cambridge University Hospitals, Cambridge
    7. 7 Clinical trials Unit, NHS Blood and Transplant, Cambridge, UK
    8. 8 Renal and Transplant, North Bristol NHS Trust, Westbury on Trym, UK
    9. 9 Department of Clinical Surgery, Royal Infirmary of Edinburgh, Edinburgh, UK
    10. 10 Department of Nephrology, Epsom and St Helier University Hospitals NHS Trust, Epsom, UK
    11. 11 Renal transplantation and nephrology, University Hospitals Coventry and Warwickshire NHS Trust, Coventry, UK
    12. 12 Nottingham Renal and Kidney Transplant Unit, Nottingham University Hospitals NHS Trust, Nottingham, UK
    13. 13 Sussex Kidney Unit, Brighton and Sussex University Hospitals NHS Trust, Brighton, UK
    14. 14 Nephrology Department, Frimley Health NHS Foundation Trust, Frimley, UK
    15. 15 Department of Vascular Surgery, Imperial College London Department of Surgery and Cancer, London, UK
    16. 16 Department of Surgery, University Hospitals of Leicester NHS Trust, Leicester, UK
    17. 17 Department of Surgery, Barts Health NHS Trust, London, UK
    18. 18 Hull York Medical School, Hull University Teaching Hospitals NHS Trust, Hull, UK
    19. 19 Renal Transplant Unit, Manchester University NHS Foundation Trust, Manchester, UK
    20. 20 Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK
    21. 21 Renal Transplant Department, Portsmouth Hospitals NHS Trust, Portsmouth Hospitals NHS Trust, Portsmouth, UK
    22. 22 Transplant Unit, Guy’s and Saint Thomas' Hospitals NHS Trust, London, UK
    1. Correspondence to Gavin Pettigrew; gjp25{at}cam.ac.uk

    Abstract

    Introduction Arteriovenous fistulas (AVFs) are considered the best and safest modality for providing haemodialysis in patients with end-stage renal disease. Only 20% of UK centres achieve the recommended 80% target for achieving dialysis of the prevalent dialysis population via permanent access (as opposed to a central venous catheter). This is partly due to the relatively poor maturation rate of newly created fistulas, with as many as 50% of fistulas failing to mature.

    The Surveillance Of arterioveNous fistulAe using ultRasound study will examine whether a protocolised programme of Doppler ultrasound (US) surveillance can identify, early after creation, potentially correctable problems in those AVFs that subsequently fail to mature.

    Methods and analysis This is a multicentre observational study that will assess newly created AVFs by Doppler US performed at 2, 4, 6 and 10 weeks after creation. The primary outcome measure will be primary fistula patency at week 10. Secondary outcome measures include: successful use of the fistula; clinical suitability for dialysis; creation of new fistula or radiological salvage; fistula thrombosis; secondary fistula patency rate and patient acceptability.

    Ethics and dissemination The study has been approved by the Cambridgeshire and Hertfordshire Research Ethics Committee and by the Health Research Authority (REC 18/EE/0234). The results generated from this work will be published as open access, within 3 years of trial commencement. We will also present our findings at key national/international renal meetings, as well as support volunteers at renal patient groups to disseminate the trial outcome.

    Trial registration number ISRCTN36033877

    • end stage renal failure
    • dialysis
    • surgery
    • ultrasound

    This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.

    https://doi.org/10.1136/bmjopen-2019-031210

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      Footnotes

      • Contributors JR, MH, MS, DS, MB, VK, EW, RL, AS, CF, EL, VH, CFC, CH, HT, ST, AT, SS, JH, SD, SL, TS, MA, AB, RS, GS, ZM, SK, PG, RM, NB and GP contributed to the development and implementation of this protocol and have approved this manuscript. All members of the Trial Group were involved in the development of the study.

      • Funding This study is funded by National Institute for Health Research (NIHR) Health Technology Assessment Board (grant reference 17/27/11). JR and DS are funded by NIHR Academic Clinical Lectureships.

      • Disclaimer The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care.

      • Competing interests None declared.

      • Provenance and peer review Not commissioned; peer reviewed for ethical and funding approval prior to submission.

      • Collaborators SONAR TRIAL Group: Anna Sidders, Cara Hudson, Claire Foley, Valerie Hopkins, Emma Laing, Chloe Fitzpatrick-Creamer, Helen Thomas, Alison Deary (NHS Blood and Transplant Clinical Trials Unit). Gavin Pettigrew, James Richards, Mohammed Hossain, Dominic Summers, Matthew Slater, Regin Lagaac, Veena Surendrakumar, Tobi Ayorinde, Igor Chipurovski, Subhankar Paul (Cambridge University Hospital). Simon Knight, Klaus Bond, Elizabeth Hardy, Joanne Widdup, Rachael Potter, Elisabeth Pugh, Karen Parsons, Kathryn Lafferty (Oxford University Hospitals NHS Foundation Trust). Rajesh Sivaprakasam, Kate Crawford, Amy Bolsworth, Naavalah Ngwa-Ndifor (Bart’s Health NHS Trust). Reza Motallebzadeh, Matthew Bartlett, Rani Badhan (Royal Free London NHS Foundation Trust). Zia Moinuddin, Helena Edlin, Anna Jerram, Jessica Lai, Joyce Banda, Janet Bendle (Manchester University NHS Foundation Trust). Sam Turner, Maria Morgan, William Owen, Sue Dawson, Simon Daniel, Karen Allsop, (North Bristol NHS Trust). Andrew Tambyraja, Sarah-Jane Carmichael, Tom Eadie, Rona Lochiel, Midel Lena (Royal Infirmary of Edinburgh, NHS Lothian). Nicholas Barnett, Soundrie Padayachee, Philip Eldridge, May Rabuya (Guy’s & St Thomas’ NHS Foundation Trust). Subash Somalanka, Jashree Patel, Abbas Ghazanfar, Judy van Selm, Caroline Bodneck, Martia Augustin, Kwame Ansu, Nalin Khosla, Kashif Burney, Karen Dear (Epsom and St Helier University Hospitals NHS Trust). James Hunter, Carl Tiivas, Samantha Hyndman, Maria Truslove (University Hospital Coventry and Warwickshire NHS Trust). Sam Dutta, Andrew Beech, Sarah Brand (Nottingham University Hospitals NHS Trust). Sarah Lawman, Darren Cheal, Mel Smith, Kate Trivedi (Brighton & Sussex University Hospitals NHS Trust). Tracey Salter, Adnan Bajwa, John Kerr, Ana Fleet, Lianne Chapman, Sarah Gee, Thanuja Weerasinghe (Frimley Health NHS Foundation Trust). George Smith, Paris Cai, Judith Long, Tracey Rowe (Hull University Teaching Hospitals NHS Trust). Mohammed Aslam, Jeremy Crane (Imperial College Healthcare NHS Trust). Atul Bagul, Mary Quashie-Akponeware (University Hospitals of Leicester NHS Trust). Paul Gibbs (Portsmouth Hospitals NHS Trust).

      • Patient consent for publication Not required.