The perioperative administration of dexamethasone and infection (PADDI) trial protocol

rationale and design of a pragmatic multicentre non-inferiority study

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

Research output: Contribution to journalArticleOtherpeer-review

1 Citation (Scopus)

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.

Original languageEnglish
Article numbere030402
Number of pages10
JournalBMJ Open
Volume9
Issue number9
DOIs
Publication statusPublished - 6 Sep 2019

Keywords

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

Cite this

Corcoran, T. B., Myles, P. S., Forbes, A. B., O'Loughlin, E., Leslie, K., Story, D., ... Australian and New Zealand College of Anaesthetists Clinical Trials Network (ANZCA), and the Australian Society for Infectious Diseases (ASID) Clinical Research Network (2019). The perioperative administration of dexamethasone and infection (PADDI) trial protocol: rationale and design of a pragmatic multicentre non-inferiority study. BMJ Open, 9(9), [e030402]. https://doi.org/10.1136/bmjopen-2019-030402
Corcoran, Tomás B. ; Myles, Paul S. ; Forbes, Andrew B. ; O'Loughlin, Ed ; Leslie, Kate ; Story, David ; Short, Timothy G. ; Chan, Matthew Tv ; Coutts, Pauline ; Sidhu, Jaspreet ; Cheng, Allen C. ; Bach, Leon A. ; Ho, Kwok M. ; Australian and New Zealand College of Anaesthetists Clinical Trials Network (ANZCA), and the Australian Society for Infectious Diseases (ASID) Clinical Research Network. / The perioperative administration of dexamethasone and infection (PADDI) trial protocol : rationale and design of a pragmatic multicentre non-inferiority study. In: BMJ Open. 2019 ; Vol. 9, No. 9.
@article{e0b46e64ad7f4650b1f236ca19e253cd,
title = "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.",
keywords = "Dexamethasone, Diabetes, glucocorticoid, Postoperative Nausea and Vomiting, Surgical Wound Infection",
author = "Corcoran, {Tom{\'a}s B.} and Myles, {Paul S.} and Forbes, {Andrew B.} and Ed O'Loughlin and Kate Leslie and David Story and Short, {Timothy G.} and Chan, {Matthew Tv} and Pauline Coutts and Jaspreet Sidhu and Cheng, {Allen C.} and Bach, {Leon A.} and Ho, {Kwok M.} and {Australian and New Zealand College of Anaesthetists Clinical Trials Network (ANZCA), and the Australian Society for Infectious Diseases (ASID) Clinical Research Network}",
year = "2019",
month = "9",
day = "6",
doi = "10.1136/bmjopen-2019-030402",
language = "English",
volume = "9",
journal = "BMJ Open",
issn = "2044-6055",
publisher = "BMJ Publishing Group",
number = "9",

}

Corcoran, TB, Myles, PS, Forbes, AB, O'Loughlin, E, Leslie, K, Story, D, Short, TG, Chan, MT, Coutts, P, Sidhu, J, Cheng, AC, Bach, LA, Ho, KM & Australian and New Zealand College of Anaesthetists Clinical Trials Network (ANZCA), and the Australian Society for Infectious Diseases (ASID) Clinical Research Network 2019, 'The perioperative administration of dexamethasone and infection (PADDI) trial protocol: rationale and design of a pragmatic multicentre non-inferiority study', BMJ Open, vol. 9, no. 9, e030402. https://doi.org/10.1136/bmjopen-2019-030402

The perioperative administration of dexamethasone and infection (PADDI) trial protocol : rationale and design of a pragmatic multicentre non-inferiority study. / Corcoran, Tomás B.; Myles, Paul S.; Forbes, Andrew B.; O'Loughlin, Ed; Leslie, Kate; Story, David; Short, Timothy G.; Chan, Matthew Tv; Coutts, Pauline; Sidhu, Jaspreet; Cheng, Allen C.; Bach, Leon A.; Ho, Kwok M.; Australian and New Zealand College of Anaesthetists Clinical Trials Network (ANZCA), and the Australian Society for Infectious Diseases (ASID) Clinical Research Network.

In: BMJ Open, Vol. 9, No. 9, e030402, 06.09.2019.

Research output: Contribution to journalArticleOtherpeer-review

TY - JOUR

T1 - The perioperative administration of dexamethasone and infection (PADDI) trial protocol

T2 - rationale and design of a pragmatic multicentre non-inferiority study

AU - Corcoran, Tomás B.

AU - Myles, Paul S.

AU - Forbes, Andrew B.

AU - O'Loughlin, Ed

AU - Leslie, Kate

AU - Story, David

AU - Short, Timothy G.

AU - Chan, Matthew Tv

AU - Coutts, Pauline

AU - Sidhu, Jaspreet

AU - Cheng, Allen C.

AU - Bach, Leon A.

AU - Ho, Kwok M.

AU - Australian and New Zealand College of Anaesthetists Clinical Trials Network (ANZCA), and the Australian Society for Infectious Diseases (ASID) Clinical Research Network

PY - 2019/9/6

Y1 - 2019/9/6

N2 - 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.

AB - 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.

KW - Dexamethasone

KW - Diabetes

KW - glucocorticoid

KW - Postoperative Nausea and Vomiting

KW - Surgical Wound Infection

UR - http://www.scopus.com/inward/record.url?scp=85071896727&partnerID=8YFLogxK

U2 - 10.1136/bmjopen-2019-030402

DO - 10.1136/bmjopen-2019-030402

M3 - Article

VL - 9

JO - BMJ Open

JF - BMJ Open

SN - 2044-6055

IS - 9

M1 - e030402

ER -