PACMAN trial protocol, Perioperative Administration of Corticotherapy on Morbidity and mortality After Non-cardiac major surgery: a randomised, multicentre, double-blind, superiority study

IntroductionPostoperative complications are major healthcare problems and are associated with a reduced short-term and long-term survival after surgery. An excessive postoperative inflammatory response participates to the development of postoperative infection and mortality. The aim of the Periopera...

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Veröffentlicht in:BMJ open 2019-03, Vol.9 (3), p.e021262-e021262
Hauptverfasser: Asehnoune, Karim, Futier, Emmanuel, Feuillet, Fanny, Roquilly, Antoine
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Futier, Emmanuel
Feuillet, Fanny
Roquilly, Antoine
description IntroductionPostoperative complications are major healthcare problems and are associated with a reduced short-term and long-term survival after surgery. An excessive postoperative inflammatory response participates to the development of postoperative infection and mortality. The aim of the Perioperative Administration of Corticotherapy on Morbidity and mortality After Non-cardiac surgery (PACMAN) study is to assess the effectiveness of perioperative administration of corticosteroid to reduce postoperative morbidity and mortality in patients undergoing major non-cardiac surgery.Methods and analysisThe PACMAN is a multicentre, randomised, controlled, double-blind, superiority, two-arm trial of 1222 high-risk patients aged 50 years or older undergoing major non-cardiac surgery at 32 acute care hospital in France. Patients are randomly assigned to dexamethasone (0.2 mg/kg at the end of the surgical procedure and at day +1, n=611) or to placebo (n=611). The primary outcome is a composite of predefined 14-day major pulmonary complications and mortality. Secondary outcomes are surgical complications, infections, organ failures, critical care-free days, length of hospital stay and all-cause mortality at 28 days.Ethics and disseminationThe PACMAN trial protocol has been approved by the ethics committee of Sud Mediterranée V, and will be carried out according to the Good Clinical Practice guidelines and the principles of the Declaration of Helsinki. The PACMAN trial is a randomised controlled trial powered to investigate whether perioperative administration of corticosteroids in patients undergoing non-cardiac major surgery reduces postoperative complications. The results of this study will be disseminated through presentation at scientific conferences and publication in peer-reviewed journals.Trial registration numberNCT03218553; Pre-results.
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An excessive postoperative inflammatory response participates to the development of postoperative infection and mortality. The aim of the Perioperative Administration of Corticotherapy on Morbidity and mortality After Non-cardiac surgery (PACMAN) study is to assess the effectiveness of perioperative administration of corticosteroid to reduce postoperative morbidity and mortality in patients undergoing major non-cardiac surgery.Methods and analysisThe PACMAN is a multicentre, randomised, controlled, double-blind, superiority, two-arm trial of 1222 high-risk patients aged 50 years or older undergoing major non-cardiac surgery at 32 acute care hospital in France. Patients are randomly assigned to dexamethasone (0.2 mg/kg at the end of the surgical procedure and at day +1, n=611) or to placebo (n=611). The primary outcome is a composite of predefined 14-day major pulmonary complications and mortality. Secondary outcomes are surgical complications, infections, organ failures, critical care-free days, length of hospital stay and all-cause mortality at 28 days.Ethics and disseminationThe PACMAN trial protocol has been approved by the ethics committee of Sud Mediterranée V, and will be carried out according to the Good Clinical Practice guidelines and the principles of the Declaration of Helsinki. The PACMAN trial is a randomised controlled trial powered to investigate whether perioperative administration of corticosteroids in patients undergoing non-cardiac major surgery reduces postoperative complications. The results of this study will be disseminated through presentation at scientific conferences and publication in peer-reviewed journals.Trial registration numberNCT03218553; Pre-results.</description><identifier>ISSN: 2044-6055</identifier><identifier>EISSN: 2044-6055</identifier><identifier>DOI: 10.1136/bmjopen-2017-021262</identifier><identifier>PMID: 30904834</identifier><language>eng</language><publisher>England: BMJ Publishing Group LTD</publisher><subject><![CDATA[Abdomen ; Anaesthesia ; Bacterial infections ; Bacteriology ; Cardiology and cardiovascular system ; Clinical practice guidelines ; Clinical Protocols ; Critical Care - statistics & numerical data ; Dexamethasone - administration & dosage ; Double-blind studies ; Drug dosages ; Emerging diseases ; Evidence-based medicine ; Failure ; Female ; Glucocorticoids - administration & dosage ; Hospitals ; Human health and pathology ; Humans ; Infectious diseases ; Inflammation - etiology ; Inflammation - prevention & control ; Infusions, Intravenous ; Intensive care ; Length of Stay - statistics & numerical data ; Life Sciences ; Male ; Microbiology and Parasitology ; Middle Aged ; Morbidity ; Mortality ; Parasitology ; Patients ; Perioperative care ; Perioperative Care - methods ; Pneumonia ; Postoperative Complications - mortality ; Postoperative Complications - prevention & control ; Respiratory Tract Diseases - etiology ; Respiratory Tract Diseases - prevention & control ; Risk Adjustment - methods ; Steroids ; Surgical Procedures, Operative - adverse effects ; Systematic review ; Trauma ; Ventilators ; Virology ; Wound healing]]></subject><ispartof>BMJ open, 2019-03, Vol.9 (3), p.e021262-e021262</ispartof><rights>Author(s) (or their employer(s)) 2019. 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An excessive postoperative inflammatory response participates to the development of postoperative infection and mortality. The aim of the Perioperative Administration of Corticotherapy on Morbidity and mortality After Non-cardiac surgery (PACMAN) study is to assess the effectiveness of perioperative administration of corticosteroid to reduce postoperative morbidity and mortality in patients undergoing major non-cardiac surgery.Methods and analysisThe PACMAN is a multicentre, randomised, controlled, double-blind, superiority, two-arm trial of 1222 high-risk patients aged 50 years or older undergoing major non-cardiac surgery at 32 acute care hospital in France. Patients are randomly assigned to dexamethasone (0.2 mg/kg at the end of the surgical procedure and at day +1, n=611) or to placebo (n=611). The primary outcome is a composite of predefined 14-day major pulmonary complications and mortality. 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control</topic><topic>Infusions, Intravenous</topic><topic>Intensive care</topic><topic>Length of Stay - statistics &amp; numerical data</topic><topic>Life Sciences</topic><topic>Male</topic><topic>Microbiology and Parasitology</topic><topic>Middle Aged</topic><topic>Morbidity</topic><topic>Mortality</topic><topic>Parasitology</topic><topic>Patients</topic><topic>Perioperative care</topic><topic>Perioperative Care - methods</topic><topic>Pneumonia</topic><topic>Postoperative Complications - mortality</topic><topic>Postoperative Complications - prevention &amp; control</topic><topic>Respiratory Tract Diseases - etiology</topic><topic>Respiratory Tract Diseases - prevention &amp; control</topic><topic>Risk Adjustment - methods</topic><topic>Steroids</topic><topic>Surgical Procedures, Operative - adverse effects</topic><topic>Systematic review</topic><topic>Trauma</topic><topic>Ventilators</topic><topic>Virology</topic><topic>Wound healing</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Asehnoune, Karim</creatorcontrib><creatorcontrib>Futier, Emmanuel</creatorcontrib><creatorcontrib>Feuillet, Fanny</creatorcontrib><creatorcontrib>Roquilly, Antoine</creatorcontrib><creatorcontrib>PACMAN group</creatorcontrib><collection>BMJ Open Access Journals</collection><collection>BMJ Journals:Open Access</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Nursing &amp; 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An excessive postoperative inflammatory response participates to the development of postoperative infection and mortality. The aim of the Perioperative Administration of Corticotherapy on Morbidity and mortality After Non-cardiac surgery (PACMAN) study is to assess the effectiveness of perioperative administration of corticosteroid to reduce postoperative morbidity and mortality in patients undergoing major non-cardiac surgery.Methods and analysisThe PACMAN is a multicentre, randomised, controlled, double-blind, superiority, two-arm trial of 1222 high-risk patients aged 50 years or older undergoing major non-cardiac surgery at 32 acute care hospital in France. Patients are randomly assigned to dexamethasone (0.2 mg/kg at the end of the surgical procedure and at day +1, n=611) or to placebo (n=611). The primary outcome is a composite of predefined 14-day major pulmonary complications and mortality. Secondary outcomes are surgical complications, infections, organ failures, critical care-free days, length of hospital stay and all-cause mortality at 28 days.Ethics and disseminationThe PACMAN trial protocol has been approved by the ethics committee of Sud Mediterranée V, and will be carried out according to the Good Clinical Practice guidelines and the principles of the Declaration of Helsinki. The PACMAN trial is a randomised controlled trial powered to investigate whether perioperative administration of corticosteroids in patients undergoing non-cardiac major surgery reduces postoperative complications. The results of this study will be disseminated through presentation at scientific conferences and publication in peer-reviewed journals.Trial registration numberNCT03218553; Pre-results.</abstract><cop>England</cop><pub>BMJ Publishing Group LTD</pub><pmid>30904834</pmid><doi>10.1136/bmjopen-2017-021262</doi><orcidid>https://orcid.org/0000-0002-6454-271X</orcidid><orcidid>https://orcid.org/0000-0002-2870-6115</orcidid><orcidid>https://orcid.org/0000-0003-1899-3517</orcidid><orcidid>https://orcid.org/0000-0002-5478-482X</orcidid><orcidid>https://orcid.org/0000-0002-4424-4280</orcidid><orcidid>https://orcid.org/0000-0001-6073-4354</orcidid><orcidid>https://orcid.org/0000-0001-5804-5269</orcidid><orcidid>https://orcid.org/0000-0002-6938-0967</orcidid><orcidid>https://orcid.org/0000-0002-7257-8069</orcidid><orcidid>https://orcid.org/0000-0002-1029-6242</orcidid><oa>free_for_read</oa></addata></record>
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source BMJ Open Access Journals; MEDLINE; DOAJ Directory of Open Access Journals; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; PubMed Central; PubMed Central Open Access
subjects Abdomen
Anaesthesia
Bacterial infections
Bacteriology
Cardiology and cardiovascular system
Clinical practice guidelines
Clinical Protocols
Critical Care - statistics & numerical data
Dexamethasone - administration & dosage
Double-blind studies
Drug dosages
Emerging diseases
Evidence-based medicine
Failure
Female
Glucocorticoids - administration & dosage
Hospitals
Human health and pathology
Humans
Infectious diseases
Inflammation - etiology
Inflammation - prevention & control
Infusions, Intravenous
Intensive care
Length of Stay - statistics & numerical data
Life Sciences
Male
Microbiology and Parasitology
Middle Aged
Morbidity
Mortality
Parasitology
Patients
Perioperative care
Perioperative Care - methods
Pneumonia
Postoperative Complications - mortality
Postoperative Complications - prevention & control
Respiratory Tract Diseases - etiology
Respiratory Tract Diseases - prevention & control
Risk Adjustment - methods
Steroids
Surgical Procedures, Operative - adverse effects
Systematic review
Trauma
Ventilators
Virology
Wound healing
title PACMAN trial protocol, Perioperative Administration of Corticotherapy on Morbidity and mortality After Non-cardiac major surgery: a randomised, multicentre, double-blind, superiority study
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