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

Karim Asehnoune, Emmanuel Futier, Fanny Feuillet, Antoine Roquilly, PACMAN group, Sigismond Lasocki, Olivier Huet, Jean-Etienne Bazin, Catherine Paugam-Burtz, Gilbert Lorre, Charlène Le Moal, Gilles Lebuffe, Guillaume Belliard, Thomas Rimmele, Vincent Piriou, Nicolas Bruder, Marc Leone, Djamel Mokart, Samir Jaber, Nolwen Chatel-Josse, Bertrand Rozec, Frederic Simonneau, Florent Capron, Philippe Cuvillon, Marc Beaussier, Benoit Plaud, Jean Mantz, Bertrand Debaenne, Benny Charbit, Hélène Beloeil, Bertrand Dureuil, Serge Molliex, Julien Pottecher, Thomas Geeraerts, Karim Asehnoune, Emmanuel Futier, Fanny Feuillet, Antoine Roquilly, PACMAN group, Sigismond Lasocki, Olivier Huet, Jean-Etienne Bazin, Catherine Paugam-Burtz, Gilbert Lorre, Charlène Le Moal, Gilles Lebuffe, Guillaume Belliard, Thomas Rimmele, Vincent Piriou, Nicolas Bruder, Marc Leone, Djamel Mokart, Samir Jaber, Nolwen Chatel-Josse, Bertrand Rozec, Frederic Simonneau, Florent Capron, Philippe Cuvillon, Marc Beaussier, Benoit Plaud, Jean Mantz, Bertrand Debaenne, Benny Charbit, Hélène Beloeil, Bertrand Dureuil, Serge Molliex, Julien Pottecher, Thomas Geeraerts

Abstract

Introduction: Postoperative 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 analysis: The 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 dissemination: The 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 number: NCT03218553; Pre-results.

Keywords: dexamethasone; glucocorticoid; pneumonia; post-operative complications; surgery.

Conflict of interest statement

Competing interests: None declared.

© 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.

Figures

Figure 1
Figure 1
Flow chart. CRP, C reactive protein.

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