Paul S Myles1, Jan M Dieleman2, Andrew Forbes3, Stephane Heritier3, Julian A Smith4. 1. Department of Anaesthesia and Perioperative Medicine, Alfred Hospital, Melbourne, Victoria, Australia; Department of Anaesthesia and Perioperative Medicine, Central Clinical School, Monash University, Melbourne, Victoria, Australia; Department of Epidemiology and Preventive Medicine, School of Public Health and Epidemiology, Monash University; Melbourne, Victoria, Australia. Electronic address: p.myles@alfred.org.au. 2. Department of Anaesthesia, University Medical Center, Utrecht, The Netherlands. 3. Department of Epidemiology and Preventive Medicine, School of Public Health and Epidemiology, Monash University; Melbourne, Victoria, Australia. 4. Department of Cardiothoracic Surgery, Monash Health, Melbourne, Victoria, Australia; Department of Surgery, School of Clinical Sciences at Monash Health, Monash University, Clayton, Victoria, Australia.
Abstract
BACKGROUND: Numerous studies have investigated high-dose corticosteroids in cardiac surgery, but with mixed results leading to ongoing variations in practice around the world. DECS-II is a study comparing high-dose dexamethasone with placebo in patients undergoing cardiac surgery. METHODS: We discuss the rationale for conducting DECS-II, a 2800-patient, pragmatic, multicenter, assessor-blinded, randomized trial in cardiac surgery, and the features of the DECS-II study design (objectives, end points, target population, based on practice preference with post-randomization consent, treatments, patient follow-up and analysis). CONCLUSIONS: The DECS-II trial will use a novel, efficient trial design to evaluate whether high-dose dexamethasone has a patient-centered benefit of enhancing recovery and increasing the number of days at home after cardiac surgery.
RCT Entities:
BACKGROUND: Numerous studies have investigated high-dose corticosteroids in cardiac surgery, but with mixed results leading to ongoing variations in practice around the world. DECS-II is a study comparing high-dose dexamethasone with placebo in patients undergoing cardiac surgery. METHODS: We discuss the rationale for conducting DECS-II, a 2800-patient, pragmatic, multicenter, assessor-blinded, randomized trial in cardiac surgery, and the features of the DECS-II study design (objectives, end points, target population, based on practice preference with post-randomization consent, treatments, patient follow-up and analysis). CONCLUSIONS: The DECS-II trial will use a novel, efficient trial design to evaluate whether high-dose dexamethasone has a patient-centered benefit of enhancing recovery and increasing the number of days at home after cardiac surgery.
Authors: Abraham H Hulst; Maarten J Visscher; Marc B Godfried; Bram Thiel; Bastiaan M Gerritse; Thierry V Scohy; R Arthur Bouwman; Mark G A Willemsen; Markus W Hollmann; Benedikt Preckel; J Hans DeVries; Jeroen Hermanides Journal: Diabetes Obes Metab Date: 2019-12-17 Impact factor: 6.577