Dexamethasone for Cardiac Surgery-II Trial

Summary

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.

Timeline

Start

2018-09-01

Primary completion

2023-01-31

Completion

2023-01-31

Publications

• Abbasciano RG, Olivieri GM, Chubsey R, Gatta F, Tyson N, Easwarakumar K, Fudulu DP, Marsico R, Kofler M, Elshafie G, Lai F, Loubani M, Kendall S, Zakkar M, Murphy GJ. Prophylactic corticosteroids for cardiopulmonary bypass in adult cardiac surgery. Cochrane Database Syst Rev. 2024 Mar 20;3(3):CD005566. doi: 10.1002/14651858.CD005566.pub4.
• Myles PS, Dieleman JM, Forbes A, Heritier S, Smith JA. Dexamethasone for Cardiac Surgery trial (DECS-II): Rationale and a novel, practice preference-randomized consent design. Am Heart J. 2018 Oct;204:52-57. doi: 10.1016/j.ahj.2018.06.008. Epub 2018 Jun 21.

Drugs

Indications