Corticosteroids in Pediatric Shock: A Call to Arms

Area of Science:

• Pediatric critical care medicine
• Pharmacology
• Clinical trial design

Background:

• Corticosteroid use in pediatric septic shock is of significant interest.
• A definitive randomized controlled trial (RCT) is lacking.
• Previous studies have explored adrenal function and steroid use in critically ill children.

Purpose of the Study:

• To identify critical issues for designing and implementing a definitive RCT on adjunctive corticosteroid use in pediatric septic shock.
• To outline the necessary steps for a successful clinical trial in this area.
• To facilitate the initiation of a much-needed research study.

Main Methods:

• Systematic review of pediatric studies from MEDLINE and Embase databases (1946–2015).
• Focused on adrenal function and steroid use in critically ill children with systemic inflammatory response syndrome, sepsis, or septic shock.
• Discussion of relevant points from the reviewed literature.

Main Results:

• Several issues must be resolved before a definitive RCT can be conducted.
• These include identifying the precise target population for the trial.
• Achieving equipoise among clinicians and the community is essential.
• Selecting a patient-centered, clinically meaningful primary outcome measure is crucial.
• Careful consideration of potential adverse effects of corticosteroids is necessary.

Conclusions:

• The time is appropriate to conduct a trial on corticosteroids in pediatric septic shock.
• The central question is whether corticosteroids benefit some children without causing harm.
• Conducting such a trial requires a collaborative effort from ethics boards, families, clinicians, and researchers.
• An international planning meeting is proposed to reach agreement on identified issues.