Pacman trial protocol, perioperative ...
Type de document :
Article dans une revue scientifique: Article original
PMID :
URL permanente :
Titre :
Pacman trial protocol, perioperative administration of corticotherapy on morbidity and mortality after non-cardiac major surgery: a randomised, multicentre, double-blind, superiority study
Auteur(s) :
Asehnoune, Karim [Auteur]
Centre Hospitalier Universitaire de Nantes [CHU Nantes]
Futier, Emmanuel [Auteur]
CHU Clermont-Ferrand
Feuillet, Fanny [Auteur]
Centre Hospitalier Universitaire de Nantes [CHU Nantes]
Roquilly, Antoine [Auteur]
Centre Hospitalier Universitaire de Nantes [CHU Nantes]
Futier, Emmanuel [Auteur]
CHU Clermont-Ferrand
Feuillet, Fanny [Auteur]
Centre Hospitalier Universitaire de Nantes [CHU Nantes]
Roquilly, Antoine [Auteur]
Titre de la revue :
BMJ open
Nom court de la revue :
BMJ Open
Numéro :
9
Pagination :
e021262
Date de publication :
2019-03-23
ISSN :
2044-6055
Discipline(s) HAL :
Sciences du Vivant [q-bio]
Résumé en anglais : [en]
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 ...
Lire la suite >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. 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. 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. NCT03218553; Pre-results.Lire moins >
Lire la suite >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. 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. 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. NCT03218553; Pre-results.Lire moins >
Langue :
Anglais
Audience :
Internationale
Vulgarisation :
Non
Collections :
Équipe(s) de recherche :
Modélisation biopharmaceutique et pharmacocinétique
Date de dépôt :
2019-12-16T14:06:39Z
2021-06-15T12:57:48Z
2021-06-15T12:57:48Z
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