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The perioperative administration of dexamethasone and infection (PADDI) trial protocol: rationale and design of a pragmatic multicentre non-inferiority study
  1. Tomás B Corcoran1,2,3,
  2. Paul S Myles3,4,
  3. Andrew B Forbes3,
  4. Ed O'Loughlin2,5,
  5. Kate Leslie3,6,7,
  6. David Story6,7,
  7. Timothy G Short8,
  8. Matthew TV Chan9,
  9. Pauline Coutts1,
  10. Jaspreet Sidhu3,
  11. Allen C Cheng3,4,
  12. Leon A Bach3,4,
  13. Kwok M Ho1,2
  14. on behalf of the Australian and New Zealand College of Anaesthetists Clinical Trials Network (ANZCA), and the Australian Society for Infectious Diseases (ASID) Clinical Research Network
    1. 1 Royal Perth Hospital, Perth, Western Australia, Australia
    2. 2 University of Western Australia, Perth, Western Australia, Australia
    3. 3 Monash University, Melbourne, Victoria, Australia
    4. 4 Alfred Hospital, Melbourne, Victoria, Australia
    5. 5 Fiona Stanley Hospital, Perth, Western Australia, Australia
    6. 6 Royal Melbourne Hospital, Melbourne, Victoria, Australia
    7. 7 The University of Melbourne, Melbourne, Victoria, Australia
    8. 8 Auckland City Hospital, Grafton, Auckland, New Zealand
    9. 9 Chinese University of Hong Kong, Shatin, Hong Kong, China
    1. Correspondence to Tomás B Corcoran; mascor{at}bigpond.net.au

    Abstract

    Introduction The intraoperative administration of dexamethasone for prophylaxis against postoperative nausea and vomiting is a common and recommended practice. The safety of the administration of this immunosuppressive agent at a time of significant immunological disruption has not been rigorously evaluated in terms of infective complications.

    Methods/analysis This is a pragmatic, multicentre, randomised, controlled, non-inferiority trial. A total of 8880 patients undergoing elective major surgery will be enrolled. Participants will be randomly allocated to receive either dexamethasone 8 mg or placebo intravenously following the induction of anaesthesia in a 1:1 ratio, stratified by centre and diabetes status. Patient enrolment into the trial is ongoing. The primary outcome is surgical site infection at 30 days following surgery, defined according to the Centre for Disease Control criteria.

    Ethics/dissemination The PADDI trial has been approved by the ethics committees of over 45 participating sites in Australia, New Zealand, Hong Kong, South Africa and the Netherlands. The trial has been endorsed by the Australia and New Zealand College of Anaesthetists Clinical Trials Network and the Australian Society for Infectious Diseases Clinical Research Network. Participant recruitment began in March 2016 and is expected to be complete in mid-2019. Publication of the results of the PADDI trial is anticipated to occur in early 2020.

    Trial registration number ACTRN12614001226695.

    • Dexamethasone
    • glucocorticoid
    • Surgical Wound Infection
    • Postoperative Nausea and Vomiting
    • Diabetes

    This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

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    Footnotes

    • Collaborators The PADDI trial investigators. Data and Safety Monitoring Committee: Professor Chris Frampton [Chair] (Department of Statistics, Christchurch Clinical School of Medicine, University of Otago, New Zealand), Professor Richard Macisaac (Director of Diabetes and Endocrinology, St Vincent’s Hospital, Melbourne), Professor Michael Paech (Winthrop Professor of Obstetric Anaesthesia, University of Western Australia), Professor Bala Venkatesh (Professor of Intensive Care Medicine, University of Queensland), Associate Professor Leon Worth (Infectious Diseases Physician, Alfred Health, Melbourne). Independent Statisticians: Professor Stephane Heritier, and Dr Cathy Martin, (Monash University, Melbourne, Victoria, Australia). Endpoint Adjudication Committee: Dr Mark Williams (Department of Anaesthesia, Fiona Stanley Hospital, Perth, Western Australia), [CHAIR], Dr Roger Browning (Department of Anaesthesia, Fiona Stanley Hospital and King Edward Memorial Hospital, Perth, Western Australia), Dr Emma Hamilton (Department of Endocrinology, Fiona Stanley Hospital, Perth, Western Australia), Dr Paul Ingram (Department of Infectious Diseases, Fiona Stanley Hospital, Perth, Western Australia), Dr Peter Boan (Department of Infectious Diseases, Fiona Stanley Hospital, Perth, Western Australia).

    • Contributors TBC, PSM, ABF, EOL, KL, DS, TS, MC, ACC, LAB and KMH contributed to the conception and design of the study. TBC, PSM, JS, ABF and PC contributed to the design of the case report form and establishment of the trial database. TBC, PSM, ABF, EOL, KL, DS, TS, MC, ACC, LAB and KMH contributed to the acquisition, analysis and interpretation of the data. TBC wrote the first draft of the protocol. TBC, PSM, ABF, EOL, KL, DS, TS, MC, ACC, LAB and KMH revised the protocol critically for important intellectual content. TBC, PSM and ABF are the guarantors. All authors have read and approved the final version of the manuscript to be published.

    • Funding This work was supported by the Australian NHMRC, APP1079501, and the Research Grant Council, Hong Kong Special Administrative Region, China, General Research Fund, 14101816. Sponsor: Alfred Health, Melbourne, Victoria, Australia.

    • Competing interests None declared.

    • Patient consent for publication Not required.

    • Ethics approval The trial was approved by the Alfred Hospital Human Ethics Committee. HREC/15/Alfred/22 (Local reference: 334/15).

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Data availability statement Data are available upon reasonable request.

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