The perioperative administration of dexamethasone and infection (PADDI) trial protocol: rationale and design of a pragmatic multicentre non-inferiority study
David Story,
Allen C Cheng,
Andrew B Forbes,
Kate Leslie,
Tomás B Corcoran,
Paul S Myles,
Ed O'Loughlin,
Timothy G Short,
Matthew TV Chan,
Pauline Coutts,
Jaspreet Sidhu,
Leon A Bach,
Kwok M Ho,
Chris Frampton,
Richard Macisaac,
Michael Paech,
Bala Venkatesh,
Leon Worth,
Stephane Heritier,
Cathy Martin,
Roger Browning,
Emma Hamilton,
Paul Ingram,
Peter Boan
Affiliations
David Story
Perioperative and Pain Medicine Unit, Melbourne Medical School, The University of Melbourne, Parkville, Victoria, Australia
Allen C Cheng
4 Alfred Hospital, Melbourne, Victoria, Australia
Andrew B Forbes
1 School of Public Health and Preventive Medicine, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Victoria, Australia
Kate Leslie
Department of Critical Care, Melbourne Medical School, University of Melbourne, Melbourne, Victoria, Australia
Tomás B Corcoran
1 Royal Perth Hospital, Perth, Western Australia, Australia
Paul S Myles
Anaesthesia and Perioperative Medicine, Monash University Faculty of Medicine Nursing and Health Sciences, Clayton, Victoria, Australia
Ed O'Loughlin
2 University of Western Australia, Perth, Western Australia, Australia
Timothy G Short
8 Auckland City Hospital, Grafton, Auckland, New Zealand
Matthew TV Chan
Department of Anaesthesia and Intensive Care, The Chinese University of Hong Kong, Hong Kong, China
Pauline Coutts
1 Royal Perth Hospital, Perth, Western Australia, Australia
Jaspreet Sidhu
3 Monash University, Melbourne, Victoria, Australia
Leon A Bach
3 Monash University, Melbourne, Victoria, Australia
Kwok M Ho
2 University of Western Australia, Perth, Western Australia, Australia
Chris Frampton
6 Department of Medicine, Christchurch School of Medicine and Health Sciences, University of Otago, Christchurch, New Zealand
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.
