7
views
0
recommends
+1 Recommend
0 collections
    0
    shares
      • Record: found
      • Abstract: found
      • Article: found
      Is Open Access

      Effect of dexamethasone on complications or all cause mortality after major non-cardiac surgery: multicentre, double blind, randomised controlled trial

      research-article
      1 , , 2 , 3 , 1 , 4 , 5 , 6 , 7 , 8 , 9 , 10 , 11 , 12 , 13 , 14 , 2 , 3 , 1 , 4 , 5 , 15 , 16 , 17 , 15 , 9 , 1 PACMAN study group, , , , , , , , , , ,
      The BMJ
      BMJ Publishing Group Ltd.

      Read this article at

      Bookmark
          There is no author summary for this article yet. Authors can add summaries to their articles on ScienceOpen to make them more accessible to a non-specialist audience.

          Abstract

          Objective

          To assess the effect of dexamethasone on complications or all cause mortality after major non-cardiac surgery.

          Design

          Phase III, randomised, double blind, placebo controlled trial.

          Setting

          34 centres in France, December 2017 to March 2019.

          Participants

          1222 adults (>50 years) requiring major non-cardiac surgery with an expected duration of more than 90 minutes. The anticipated time frame for recruitment was 24 months.

          Interventions

          Participants were randomised to receive either dexamethasone (0.2 mg/kg immediately after the surgical procedure, and on day 1) or placebo. Randomisation was stratified on the two prespecified criteria of cancer and thoracic procedure.

          Main outcomes measures

          The primary outcome was a composite of postoperative complications or all cause mortality within 14 days after surgery, assessed in the modified intention-to-treat population (at least one treatment administered).

          Results

          Of the 1222 participants who underwent randomisation, 1184 (96.9%) were included in the modified intention-to-treat population. 14 days after surgery, 101 of 595 participants (17.0%) in the dexamethasone group and 117 of 589 (19.9%) in the placebo group had complications or died (adjusted odds ratio 0.81, 95% confidence interval 0.60 to 1.08; P=0.15). In the stratum of participants who underwent non-thoracic surgery (n=1038), the primary outcome occurred in 69 of 520 participants (13.3%) in the dexamethasone group and 93 of 518 (18%) in the placebo group (adjusted odds ratio 0.70, 0.50 to 0.99). Adverse events were reported in 288 of 613 participants (47.0%) in the dexamethasone group and 296 of 609 (48.6%) in the placebo group (P=0.46).

          Conclusions

          Dexamethasone was not found to significantly reduce the incidence of complications and death in patients 14 days after major non-cardiac surgery. The 95% confidence interval for the main result was, however, wide and suggests the possibility of important clinical effectiveness.

          Trial registration

          ClinicalTrials.gov NCT03218553.

          Related collections

          Most cited references41

          • Record: found
          • Abstract: found
          • Article: found

          The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3).

          Definitions of sepsis and septic shock were last revised in 2001. Considerable advances have since been made into the pathobiology (changes in organ function, morphology, cell biology, biochemistry, immunology, and circulation), management, and epidemiology of sepsis, suggesting the need for reexamination.
            Bookmark
            • Record: found
            • Abstract: found
            • Article: not found

            Dexamethasone in Hospitalized Patients with Covid-19 — Preliminary Report

            Abstract Background Coronavirus disease 2019 (Covid-19) is associated with diffuse lung damage. Glucocorticoids may modulate inflammation-mediated lung injury and thereby reduce progression to respiratory failure and death. Methods In this controlled, open-label trial comparing a range of possible treatments in patients who were hospitalized with Covid-19, we randomly assigned patients to receive oral or intravenous dexamethasone (at a dose of 6 mg once daily) for up to 10 days or to receive usual care alone. The primary outcome was 28-day mortality. Here, we report the preliminary results of this comparison. Results A total of 2104 patients were assigned to receive dexamethasone and 4321 to receive usual care. Overall, 482 patients (22.9%) in the dexamethasone group and 1110 patients (25.7%) in the usual care group died within 28 days after randomization (age-adjusted rate ratio, 0.83; 95% confidence interval [CI], 0.75 to 0.93; P<0.001). The proportional and absolute between-group differences in mortality varied considerably according to the level of respiratory support that the patients were receiving at the time of randomization. In the dexamethasone group, the incidence of death was lower than that in the usual care group among patients receiving invasive mechanical ventilation (29.3% vs. 41.4%; rate ratio, 0.64; 95% CI, 0.51 to 0.81) and among those receiving oxygen without invasive mechanical ventilation (23.3% vs. 26.2%; rate ratio, 0.82; 95% CI, 0.72 to 0.94) but not among those who were receiving no respiratory support at randomization (17.8% vs. 14.0%; rate ratio, 1.19; 95% CI, 0.91 to 1.55). Conclusions In patients hospitalized with Covid-19, the use of dexamethasone resulted in lower 28-day mortality among those who were receiving either invasive mechanical ventilation or oxygen alone at randomization but not among those receiving no respiratory support. (Funded by the Medical Research Council and National Institute for Health Research and others; RECOVERY ClinicalTrials.gov number, NCT04381936; ISRCTN number, 50189673.)
              Bookmark
              • Record: found
              • Abstract: found
              • Article: not found

              Estimate of the global volume of surgery in 2012: an assessment supporting improved health outcomes.

              It was previously estimated that 234·2 million operations were performed worldwide in 2004. The association between surgical rates and population health outcomes is not clear. We re-estimated global surgical volume to track changes over time and assess rates associated with healthy populations.
                Bookmark

                Author and article information

                Contributors
                Role: professor in anaesthesia and critical care medicine
                Role: hospital practitioner
                Role: professor in anaesthesia and critical care medicine
                Role: hospital practitioner
                Role: private hospital practitioner
                Role: hospital practitioner
                Role: professor in anaesthesia and critical care medicine
                Role: hospital practitioner
                Role: professor in anaesthesia and critical care medicine
                Role: hospital practitioner
                Role: professor in anaesthesia and critical care medicine
                Role: hospital practitioner
                Role: professor in anaesthesia and critical care medicine
                Role: hospital practitioner
                Role: hospital practitioner
                Role: hospital practitioner
                Role: hospital practitioner
                Role: hospital practitioner
                Role: private hospital practitioner
                Role: hospital practitioner
                Role: hospital pharmacist
                Role: hospital pharmacist
                Role: senior researcher in statistics
                Role: senior engineer in statistics
                Role: professor in anaesthesia and critical care medicine
                Role: professor in anaesthesia and critical care medicine
                Journal
                BMJ
                BMJ
                BMJ-UK
                bmj
                The BMJ
                BMJ Publishing Group Ltd.
                0959-8138
                1756-1833
                2021
                02 June 2021
                : 373
                : n1162
                Affiliations
                [1 ]CHU Nantes, Université de Nantes, Pôle Anesthésie-Réanimation, Service d’Anesthésie Réanimation Chirurgicale, Hôtel Dieu, Nantes, France
                [2 ]Service d’Anesthésie, Centre Hospitalier Le Mans, Le Mans, France
                [3 ]Centre Hospitalier Universitaire (CHU) Lille, Pôle Anesthésie Réanimation, Lille, France
                [4 ]Service d’Anesthésie, Hôpital Privé du Confluent, Nantes, France
                [5 ]CHU de Poitiers, Université de Poitiers, Service d’Anesthésie-Réanimation, Poitiers, France
                [6 ]Hôpital Saint Antoine, Service d’Anesthésie Réanimation Chirurgicale, Assistance publique des hôpitaux de Paris, Paris, France
                [7 ]Institut Paoli Calmette, Service d’Anesthésie, Marseille, France
                [8 ]Anesthesia and Critical Care Department B, Saint Eloi Teaching Hospital, PhyMedExp, Centre Hospitalier Universitaire Montpellier, University of Montpellier, INSERM U1046, CNRS UMR 9214, Montpellier, France
                [9 ]Service d’Anesthésie et Réanimation, Hôpital Estaing, CHU Clermont Ferrand, Clermont-Ferrand, France
                [10 ]Department of Anesthesiology and Critical Care Medicine, Hôpital Nord, Aix Marseille University, Assistance Publique Hôpitaux de Marseille, Marseille, France
                [11 ]Département d’Anesthésie & VVC, Gustave Roussy Cancer Center, Villejuif, France
                [12 ]Service d’Anesthésie Réanimation, Groupe Hospitalier Sud, Civils de Lyon, Pierre Benite, France
                [13 ]CHU Nantes, Université de Nantes, Pôle Anesthésie-Réanimation, Service d’Anesthésie Réanimation Chirurgicale, Hôpital Guillaume et René Laennec, Saint-Herblain, France
                [14 ]CH Valenciennes, Service d’Anesthésie, Valenciennes, France
                [15 ]CHU de Nantes, Direction de la Recherche, Plateforme de Méthodologie et Biostatistique, Nantes, France
                [16 ]CHU Nantes, Service Pharmacie, Hôtel Dieu, Nantes, France
                [17 ]Université de Nantes, Université de Tours, INSERM, SPHERE U1246, Nantes, France
                Author notes
                Correspondence to: K Asehnoune karim.asehnoune@ 123456chu-nantes.fr
                Author information
                http://orcid.org/0000-0003-1899-3517
                Article
                asek063910
                10.1136/bmj.n1162
                8171383
                34078591
                a30f27c1-fb48-4cc6-85fd-e4c8a61110dd
                © 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.

                This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

                History
                : 05 May 2021
                Categories
                Research

                Medicine
                Medicine

                Comments

                Comment on this article