Objective: To identify the issues needing to be resolved to design, implement, and complete a definitive randomized controlled trial of adjunctive corticosteroid use in children with septic shock.
Design: Pediatric studies from MEDLINE (1946 to January 2015) and Embase (1947 to January 2015) that addressed adrenal function or steroid use in critically ill children with systemic inflammatory response syndrome, sepsis, or septic shock were reviewed and their relevant points discussed.
Results: There is considerable interest in the field of corticosteroids in pediatric septic shock, which has not as yet translated into a much needed randomized controlled trial. We found that the issues that need to be resolved include identification of the target population, achievement of individual and community equipoise, selection of a patient centered, clinically meaningful primary outcome measure, and consideration of the adverse effects of corticosteroids.
Conclusions: We strongly believe that the time has come to conduct a trial on the use of corticosteroids in pediatric septic shock and that the question to be answered is Will corticosteroids given to children with septic shock result in a benefit to some patients without resulting in harm to others? Answering this question will require a collaborative and committed effort on the parts of ethics boards, families, clinicians, and researchers to actually make it happen once and for all, and we propose an international planning meeting of interested parties to achieve agreement on these identified issues.