Background. Numerous studies have investigated high-dose corticosteroids in cardiac surgery,
but with mixed results leading to ongoing variations in practice around the world. The
Dexamethasone for Cardiac Surgery-II Trial (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, balanced clusters 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.