Steroids in fluid and/or vasoactive infusion dependent pediatric shock: study protocol for a randomized controlled...

Area of Science:

• Pediatric Critical Care Medicine
• Clinical Pharmacology
• Evidence-Based Medicine

Background:

• Corticosteroids are frequently used for pediatric shock despite controversial evidence.
• No prior pediatric randomized controlled trials (RCTs) have investigated corticosteroid use in shock.
• Existing data suggests potential harm from corticosteroids in other patient populations.

Purpose of the Study:

• To determine the feasibility of recruiting patients for a larger RCT on corticosteroids in pediatric shock.
• To evaluate the role of hydrocortisone versus placebo in fluid and/or vasoactive infusion dependent pediatric shock.
• To inform the design of a future, adequately powered clinical trial.

Main Methods:

• The Steroids in Fluid and/or Vasoactive Infusion Dependent Pediatric Shock (STRIPES) pilot trial is a pragmatic, multi-center, double-blind, randomized controlled trial.
• 72 pediatric patients with shock will be randomized to receive hydrocortisone or placebo for 7 days or until clinical stability.
• Primary outcome is recruitment feasibility; secondary outcomes include protocol adherence, mortality, adverse events, and inotrope discontinuation.

Main Results:

• This section is not applicable for a pilot feasibility study abstract.
• The primary outcome is the feasibility of recruitment over a 1-year period.
• Secondary outcomes will provide preliminary data on safety and efficacy endpoints.

Conclusions:

• The use of corticosteroids in pediatric shock lacks robust supporting evidence.
• The STRIPES pilot study is crucial for assessing the feasibility of a larger trial.
• This research will guide future investigations into optimal pediatric shock management.