The perioperative administration of dexamethasone and infection (PADDI) trial protocol: rationale and design of a pragmatic multicentre non-inferiority study
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 e...
Saved in:
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMJ Publishing Group
2019-09-01
|
| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/9/9/e030402.full |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1850269960384806912 |
|---|---|
| author | 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 |
| author_facet | 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 |
| author_sort | David Story |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-b3c67b47198d4e68bd0570e7545da3e3 |
| institution | OA Journals |
| issn | 2044-6055 |
| language | English |
| publishDate | 2019-09-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-b3c67b47198d4e68bd0570e7545da3e32025-08-20T01:52:50ZengBMJ Publishing GroupBMJ Open2044-60552019-09-019910.1136/bmjopen-2019-030402The perioperative administration of dexamethasone and infection (PADDI) trial protocol: rationale and design of a pragmatic multicentre non-inferiority studyDavid Story0Allen C Cheng1Andrew B Forbes2Kate Leslie3Tomás B Corcoran4Paul S Myles5Ed O'Loughlin6Timothy G Short7Matthew TV Chan8Pauline Coutts9Jaspreet Sidhu10Leon A Bach11Kwok M Ho12Chris Frampton13Richard MacisaacMichael PaechBala VenkateshLeon WorthStephane HeritierCathy MartinRoger BrowningEmma Hamilton14Paul IngramPeter BoanPerioperative and Pain Medicine Unit, Melbourne Medical School, The University of Melbourne, Parkville, Victoria, Australia4 Alfred Hospital, Melbourne, Victoria, Australia1 School of Public Health and Preventive Medicine, Faculty of Medicine, Nursing and Health Sciences, Monash University, Melbourne, Victoria, AustraliaDepartment of Critical Care, Melbourne Medical School, University of Melbourne, Melbourne, Victoria, Australia1 Royal Perth Hospital, Perth, Western Australia, AustraliaAnaesthesia and Perioperative Medicine, Monash University Faculty of Medicine Nursing and Health Sciences, Clayton, Victoria, Australia2 University of Western Australia, Perth, Western Australia, Australia8 Auckland City Hospital, Grafton, Auckland, New ZealandDepartment of Anaesthesia and Intensive Care, The Chinese University of Hong Kong, Hong Kong, China1 Royal Perth Hospital, Perth, Western Australia, Australia3 Monash University, Melbourne, Victoria, Australia3 Monash University, Melbourne, Victoria, Australia2 University of Western Australia, Perth, Western Australia, Australia6 Department of Medicine, Christchurch School of Medicine and Health Sciences, University of Otago, Christchurch, New Zealand16 Scottish Drug Forum, Edinburgh, UKIntroduction 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.https://bmjopen.bmj.com/content/9/9/e030402.full |
| spellingShingle | 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 The perioperative administration of dexamethasone and infection (PADDI) trial protocol: rationale and design of a pragmatic multicentre non-inferiority study BMJ Open |
| title | The perioperative administration of dexamethasone and infection (PADDI) trial protocol: rationale and design of a pragmatic multicentre non-inferiority study |
| title_full | The perioperative administration of dexamethasone and infection (PADDI) trial protocol: rationale and design of a pragmatic multicentre non-inferiority study |
| title_fullStr | The perioperative administration of dexamethasone and infection (PADDI) trial protocol: rationale and design of a pragmatic multicentre non-inferiority study |
| title_full_unstemmed | The perioperative administration of dexamethasone and infection (PADDI) trial protocol: rationale and design of a pragmatic multicentre non-inferiority study |
| title_short | The perioperative administration of dexamethasone and infection (PADDI) trial protocol: rationale and design of a pragmatic multicentre non-inferiority study |
| title_sort | perioperative administration of dexamethasone and infection paddi trial protocol rationale and design of a pragmatic multicentre non inferiority study |
| url | https://bmjopen.bmj.com/content/9/9/e030402.full |
| work_keys_str_mv | AT davidstory theperioperativeadministrationofdexamethasoneandinfectionpadditrialprotocolrationaleanddesignofapragmaticmulticentrenoninferioritystudy AT allenccheng theperioperativeadministrationofdexamethasoneandinfectionpadditrialprotocolrationaleanddesignofapragmaticmulticentrenoninferioritystudy AT andrewbforbes theperioperativeadministrationofdexamethasoneandinfectionpadditrialprotocolrationaleanddesignofapragmaticmulticentrenoninferioritystudy AT kateleslie theperioperativeadministrationofdexamethasoneandinfectionpadditrialprotocolrationaleanddesignofapragmaticmulticentrenoninferioritystudy AT tomasbcorcoran theperioperativeadministrationofdexamethasoneandinfectionpadditrialprotocolrationaleanddesignofapragmaticmulticentrenoninferioritystudy AT paulsmyles theperioperativeadministrationofdexamethasoneandinfectionpadditrialprotocolrationaleanddesignofapragmaticmulticentrenoninferioritystudy AT edoloughlin theperioperativeadministrationofdexamethasoneandinfectionpadditrialprotocolrationaleanddesignofapragmaticmulticentrenoninferioritystudy AT timothygshort theperioperativeadministrationofdexamethasoneandinfectionpadditrialprotocolrationaleanddesignofapragmaticmulticentrenoninferioritystudy AT matthewtvchan theperioperativeadministrationofdexamethasoneandinfectionpadditrialprotocolrationaleanddesignofapragmaticmulticentrenoninferioritystudy AT paulinecoutts theperioperativeadministrationofdexamethasoneandinfectionpadditrialprotocolrationaleanddesignofapragmaticmulticentrenoninferioritystudy AT jaspreetsidhu theperioperativeadministrationofdexamethasoneandinfectionpadditrialprotocolrationaleanddesignofapragmaticmulticentrenoninferioritystudy AT leonabach theperioperativeadministrationofdexamethasoneandinfectionpadditrialprotocolrationaleanddesignofapragmaticmulticentrenoninferioritystudy AT kwokmho theperioperativeadministrationofdexamethasoneandinfectionpadditrialprotocolrationaleanddesignofapragmaticmulticentrenoninferioritystudy AT chrisframpton theperioperativeadministrationofdexamethasoneandinfectionpadditrialprotocolrationaleanddesignofapragmaticmulticentrenoninferioritystudy AT richardmacisaac theperioperativeadministrationofdexamethasoneandinfectionpadditrialprotocolrationaleanddesignofapragmaticmulticentrenoninferioritystudy AT michaelpaech theperioperativeadministrationofdexamethasoneandinfectionpadditrialprotocolrationaleanddesignofapragmaticmulticentrenoninferioritystudy AT balavenkatesh theperioperativeadministrationofdexamethasoneandinfectionpadditrialprotocolrationaleanddesignofapragmaticmulticentrenoninferioritystudy AT leonworth theperioperativeadministrationofdexamethasoneandinfectionpadditrialprotocolrationaleanddesignofapragmaticmulticentrenoninferioritystudy AT stephaneheritier theperioperativeadministrationofdexamethasoneandinfectionpadditrialprotocolrationaleanddesignofapragmaticmulticentrenoninferioritystudy AT cathymartin theperioperativeadministrationofdexamethasoneandinfectionpadditrialprotocolrationaleanddesignofapragmaticmulticentrenoninferioritystudy AT rogerbrowning theperioperativeadministrationofdexamethasoneandinfectionpadditrialprotocolrationaleanddesignofapragmaticmulticentrenoninferioritystudy AT emmahamilton theperioperativeadministrationofdexamethasoneandinfectionpadditrialprotocolrationaleanddesignofapragmaticmulticentrenoninferioritystudy AT paulingram theperioperativeadministrationofdexamethasoneandinfectionpadditrialprotocolrationaleanddesignofapragmaticmulticentrenoninferioritystudy AT peterboan theperioperativeadministrationofdexamethasoneandinfectionpadditrialprotocolrationaleanddesignofapragmaticmulticentrenoninferioritystudy AT davidstory perioperativeadministrationofdexamethasoneandinfectionpadditrialprotocolrationaleanddesignofapragmaticmulticentrenoninferioritystudy AT allenccheng perioperativeadministrationofdexamethasoneandinfectionpadditrialprotocolrationaleanddesignofapragmaticmulticentrenoninferioritystudy AT andrewbforbes perioperativeadministrationofdexamethasoneandinfectionpadditrialprotocolrationaleanddesignofapragmaticmulticentrenoninferioritystudy AT kateleslie perioperativeadministrationofdexamethasoneandinfectionpadditrialprotocolrationaleanddesignofapragmaticmulticentrenoninferioritystudy AT tomasbcorcoran perioperativeadministrationofdexamethasoneandinfectionpadditrialprotocolrationaleanddesignofapragmaticmulticentrenoninferioritystudy AT paulsmyles perioperativeadministrationofdexamethasoneandinfectionpadditrialprotocolrationaleanddesignofapragmaticmulticentrenoninferioritystudy AT edoloughlin perioperativeadministrationofdexamethasoneandinfectionpadditrialprotocolrationaleanddesignofapragmaticmulticentrenoninferioritystudy AT timothygshort perioperativeadministrationofdexamethasoneandinfectionpadditrialprotocolrationaleanddesignofapragmaticmulticentrenoninferioritystudy AT matthewtvchan perioperativeadministrationofdexamethasoneandinfectionpadditrialprotocolrationaleanddesignofapragmaticmulticentrenoninferioritystudy AT paulinecoutts perioperativeadministrationofdexamethasoneandinfectionpadditrialprotocolrationaleanddesignofapragmaticmulticentrenoninferioritystudy AT jaspreetsidhu perioperativeadministrationofdexamethasoneandinfectionpadditrialprotocolrationaleanddesignofapragmaticmulticentrenoninferioritystudy AT leonabach perioperativeadministrationofdexamethasoneandinfectionpadditrialprotocolrationaleanddesignofapragmaticmulticentrenoninferioritystudy AT kwokmho perioperativeadministrationofdexamethasoneandinfectionpadditrialprotocolrationaleanddesignofapragmaticmulticentrenoninferioritystudy AT chrisframpton perioperativeadministrationofdexamethasoneandinfectionpadditrialprotocolrationaleanddesignofapragmaticmulticentrenoninferioritystudy AT richardmacisaac perioperativeadministrationofdexamethasoneandinfectionpadditrialprotocolrationaleanddesignofapragmaticmulticentrenoninferioritystudy AT michaelpaech perioperativeadministrationofdexamethasoneandinfectionpadditrialprotocolrationaleanddesignofapragmaticmulticentrenoninferioritystudy AT balavenkatesh perioperativeadministrationofdexamethasoneandinfectionpadditrialprotocolrationaleanddesignofapragmaticmulticentrenoninferioritystudy AT leonworth perioperativeadministrationofdexamethasoneandinfectionpadditrialprotocolrationaleanddesignofapragmaticmulticentrenoninferioritystudy AT stephaneheritier perioperativeadministrationofdexamethasoneandinfectionpadditrialprotocolrationaleanddesignofapragmaticmulticentrenoninferioritystudy AT cathymartin perioperativeadministrationofdexamethasoneandinfectionpadditrialprotocolrationaleanddesignofapragmaticmulticentrenoninferioritystudy AT rogerbrowning perioperativeadministrationofdexamethasoneandinfectionpadditrialprotocolrationaleanddesignofapragmaticmulticentrenoninferioritystudy AT emmahamilton perioperativeadministrationofdexamethasoneandinfectionpadditrialprotocolrationaleanddesignofapragmaticmulticentrenoninferioritystudy AT paulingram perioperativeadministrationofdexamethasoneandinfectionpadditrialprotocolrationaleanddesignofapragmaticmulticentrenoninferioritystudy AT peterboan perioperativeadministrationofdexamethasoneandinfectionpadditrialprotocolrationaleanddesignofapragmaticmulticentrenoninferioritystudy |