PACMAN trial protocol, Perioperative Administration of Corticotherapy on Morbidity and mortality After Non-cardiac major surgery: a randomised, multicentre, double-blind, superiority study
| العنوان: | 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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| المؤلفون: | Asehnoune, Karim, Futier, Emmanuel, Feuillet, Fanny, Roquilly, Antoine, Lasocki, Sigismond, Huet, Olivier, Bazin, Jean Etienne, Paugam Burtz, Catherine, Le Moal, C, Lebuffe, G., Belliard, Guillaume, Rimmele, Thomas, Piriou, Vincent, Bruder, Nicolas, Marc, Leone, Mokart, D., Jaber, Samir, Chatel-Josse, Nolwen, Rozec, Bertrand, Simonneau, Frederic, Capron, F., Cuvillon, Philippe, Beaussier, Marc, Plaud, Benoit, Mantz, J., Debaenne, Bertrand, Charbit, B., Beloeil, Helene, Dureuil, Bertrand, Molliex, Serge, Pottecher, Julien, Geeraerts, Thomas |
| المساهمون: | Centre hospitalier universitaire de Nantes (CHU Nantes), CHU Clermont-Ferrand, Biostatistique, Recherche Clinique et Mesures Subjectives en Santé, Université de Nantes (UN), Microbes évolution phylogénie et infections (MEPHI), Institut de Recherche pour le Développement (IRD)-Aix Marseille Université (AMU)-Centre National de la Recherche Scientifique (CNRS), Centre hospitalier universitaire de Nantes [CHU Nantes], Centre Hospitalier Universitaire de Nîmes (CHU Nîmes) |
| المصدر: | BMJ Open BMJ Open, BMJ Publishing Group, 2019, 9 (3), pp.e021262. ⟨10.1136/bmjopen-2017-021262⟩ BMJ Open, 2019, 9 (3), pp.e021262. ⟨10.1136/bmjopen-2017-021262⟩ |
| بيانات النشر: | HAL CCSD, 2019. |
| سنة النشر: | 2019 |
| مصطلحات موضوعية: | Male, Respiratory Tract Diseases, law.invention, Anaesthesia, surgery, 0302 clinical medicine, Postoperative Complications, Randomized controlled trial, Clinical Protocols, law, [SDV.MHEP.MI]Life Sciences [q-bio]/Human health and pathology/Infectious diseases, Acute care, Protocol, 030212 general & internal medicine, Infusions, Intravenous, ComputingMilieux_MISCELLANEOUS, [SDV.MHEP.ME]Life Sciences [q-bio]/Human health and pathology/Emerging diseases, General Medicine, Middle Aged, 3. Good health, Surgical Procedures, Operative, [SDV.MP.VIR]Life Sciences [q-bio]/Microbiology and Parasitology/Virology, Corticosteroid, Female, Risk Adjustment, medicine.drug, medicine.medical_specialty, Critical Care, post-operative complications, medicine.drug_class, Trial protocol, dexamethasone, Placebo, Perioperative Care, 03 medical and health sciences, [SDV.MHEP.CSC]Life Sciences [q-bio]/Human health and pathology/Cardiology and cardiovascular system, medicine, Humans, pneumonia, [SDV.MP.PAR]Life Sciences [q-bio]/Microbiology and Parasitology/Parasitology, Mortality, Glucocorticoids, Dexamethasone, Inflammation, business.industry, Perioperative, Length of Stay, medicine.disease, [SDV.MP.BAC]Life Sciences [q-bio]/Microbiology and Parasitology/Bacteriology, Surgery, Pneumonia, glucocorticoid, business, 030217 neurology & neurosurgery |
| الوصف: | 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. |
| وصف الملف: | application/pdf |
| اللغة: | English |
| تدمد: | 2044-6055 |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::0db89e2d94389479fe054574c4832d1bTest https://hal-amu.archives-ouvertes.fr/hal-02509468Test |
| حقوق: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....0db89e2d94389479fe054574c4832d1b |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 20446055 |
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