The perioperative administration of dexamethasone and infection (PADDI) trial protocol: rationale and design of a pragmatic multicentre non-inferiority study.

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.

• Authors: Tomás B Corcoran, Paul S Myles, Andrew B Forbes, Ed O'Loughlin, Kate Leslie, David Story, Timothy G Short, Matthew Tv Chan, Pauline Coutts, Jaspreet Sidhu, Allen C Cheng, Leon A Bach, Kwok M Ho, Australian and New Zealand College of Anaesthetists Clinical Trials Network (ANZCA), and the Australian Society for Infectious Diseases (ASID) Clinical Research Network
• Journal: BMJ open (BMJ Open) Vol. 9 Issue 9 Pg. e030402 (09 06 2019) ISSN: 2044-6055 [Electronic] England
• PMID: 31494615 (Publication Type: Clinical Trial Protocol, Journal Article, Research Support, Non-U.S. Gov't)
• Copyright: © Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Chemical References

• Dexamethasone

Topics

• Administration, Intravenous
• Dexamethasone (administration & dosage)
• Elective Surgical Procedures (adverse effects)
• Equivalence Trials as Topic
• Humans
• Internationality
• Multicenter Studies as Topic
• Perioperative Care (methods)
• Pragmatic Clinical Trials as Topic
• Surgical Wound Infection (etiology, prevention & control)