Dexamethasone for Cardiac Surgery trial (DECS-II): Rationale and a novel, practice preference-randomized consent design - 30/10/18
, Jan M. Dieleman, MSc, PhD d, Andrew Forbes, MSc, PhD c, Stephane Heritier, MMath, MBA, PhD c, Julian A. Smith, MS, MSurgEd e, fAbstract |
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.
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| Trial Registration: www.clinicaltrials.gov NCT03002259. |
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| Conflict of interest statement: None of the authors has declared any conflict of interest. |
Vol 204
P. 52-57 - octobre 2018 Retour au numéro
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