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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 1 Emmanuel Futier 2 Fanny Feuillet 3 Antoine Roquilly 1 Sigismond Lasocki Olivier Huet Jean Etienne Bazin Catherine Paugam Burtz C Le Moal G. Lebuffe Guillaume Belliard Thomas Rimmele Vincent Piriou Nicolas Bruder Leone, Marc 4 D. Mokart Samir Jaber Nolwen Chatel-Josse Bertrand Rozec Frederic Simonneau F. Capron Philippe Cuvillon 5 Marc Beaussier Benoit Plaud J. Mantz Bertrand Debaenne B. Charbit Helene Beloeil Bertrand Dureuil Serge Molliex Julien Pottecher Thomas Geeraerts
1 CHU Nantes - Centre hospitalier universitaire de Nantes
2 CHU Clermont-Ferrand
3 Biostatistique, Recherche Clinique et Mesures Subjectives en Santé
4 MEPHI - Microbes évolution phylogénie et infections
5 CHU Nîmes - Centre Hospitalier Universitaire de Nîmes
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.
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https://hal-amu.archives-ouvertes.fr/hal-02509468
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Submitted on : Monday, March 16, 2020 - 6:22:56 PM
Last modification on : Wednesday, October 14, 2020 - 3:50:27 AM

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Karim Asehnoune, Emmanuel Futier, Fanny Feuillet, Antoine Roquilly, Sigismond Lasocki, et al.. PACMAN trial protocol, Perioperative Administration of Corticotherapy on Morbidity and mortality After Non-cardiac major surgery: a randomised, multicentre, double-blind, superiority study. BMJ Open, BMJ Publishing Group, 2019, 9 (3), pp.e021262. ⟨10.1136/bmjopen-2017-021262⟩. ⟨hal-02509468⟩

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