Overview

Dexamethasone for Cardiac Surgery-II Trial

Status:
Recruiting

Trial end date:
2022-05-01

Target enrollment:
0

Participant gender:
All

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.

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Bayside Health

Collaborator:

UMC Utrecht

Treatments:

BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate

Criteria

Inclusion Criteria:

1. Males and females, age 18 to 75 years undergoing elective cardiac surgery with
cardiopulmonary bypass

2. EuroScore-II estimated risk of 1.5% or higher

Exclusion Criteria:

1. Poor language (English or Dutch) comprehension

2. Type I diabetes

3. Endocarditis or other evidence of sepsis

4. Preoperative steroid therapy