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Stress Hydrocortisone in Pediatric Septic Shock: Protocol for a Pragmatic, Multicenter, International, Randomized,
Kusum Menon1,2, Michael S D Agus3,4, Katie O'Hearn2
1Department of Pediatrics, Children's Hospital of Eastern Ontario, ON, Canada.
Insights
This study investigates corticosteroid use in pediatric septic shock, a condition with high mortality. Results will clarify treatment guidelines for this critical pediatric illness.
Area of Science:
- Pediatric critical care medicine
- Pediatric critical illness
- Pediatric intensive care unit (PICU) research
Background:
- Septic shock is a significant cause of pediatric intensive care unit admissions with high morbidity and mortality.
- Current evidence on corticosteroid use in pediatric septic shock is inconclusive, leading to uncertainty in clinical management.
- Existing guidelines lack definitive recommendations for corticosteroid administration in this patient population.
Purpose of the Study:
- To evaluate the efficacy and safety of hydrocortisone in treating pediatric septic shock.
- To provide robust data for evidence-based recommendations on corticosteroid use in pediatric septic shock.
- To assess the impact of corticosteroids on multiple-organ dysfunction syndrome and patient outcomes.
Main Methods:
- A pragmatic, multicenter, international, randomized, double-blinded, placebo-controlled trial involving approximately 50 PICUs.
- Enrollment of up to 500 pediatric patients (1 month to 17 years 8 months) diagnosed with septic shock.
- Administration of IV hydrocortisone (2 mg/kg bolus, then 1 mg/kg every 6 hours) or placebo until vasoactive-inotropic infusions are discontinued for 12 hours or for a maximum of 7 days.
Main Results:
- The primary outcome measured is the incidence of new or progressive multiple-organ dysfunction syndrome within 28 days.
- Secondary outcomes include the composite of death or a significant decrease (≥25%) in health-related quality of life at 28 days.
- The study is powered to detect clinically significant differences in outcomes related to corticosteroid treatment.
Conclusions:
- This trial is the first adequately powered pediatric study to assess corticosteroid benefits and risks in septic shock.
- Study findings will inform future clinical practice guidelines for managing pediatric septic shock.
- Definitive data will guide decisions on corticosteroid administration in critically ill children with septic shock.
Objectives:
Septic shock accounts for approximately 8% of PICU admissions worldwide, carries significant morbidity, and has a reported mortality rate between 5% and 50% depending upon the geographic region in which it occurs. The high morbidity and mortality of this condition have led clinicians to consider corticosteroids when usual management does not achieve hemodynamic stability. However, the evidence for or against the use of corticosteroids in pediatric septic shock is currently unclear.
Design:
Pragmatic, multicenter, international, randomized, double-blinded, placebo-controlled interventional trial (ClinicalTrials.gov, NCT03401398).
Setting:
Approximately 50 PICUs from 11 countries in North America, South America and Asia.
Patients:
Up to 500 eligible pediatric patients aged one month to 17 years and 8 months with septic shock.
Interventions:
Patients randomized to the hydrocortisone arm receive an initial bolus of 2 mg/kg IV hydrocortisone, followed by 1 mg/kg every six hours until all vasoactive-inotropic infusions have been discontinued for at least 12 h or for a maximum of 7 days. Patients randomized to the placebo arm receive an equivalent volume of normal saline with the identical dosing schedule.
Measurements And Main Results:
The primary outcome is the frequency of new or progressive multiple-organ dysfunction syndrome up to 28 days following enrollment, death or discharge, whichever comes first. The secondary outcome is a composite of the frequency of death or greater than or equal to 25% decrease in health-related quality of life from baseline, assessed at 28 days.
Conclusions:
The current Pediatric Surviving Sepsis Guidelines do not provide definitive recommendations regarding the use of corticosteroids in pediatric septic shock. Our study will be the first pediatric trial that is adequately powered to assess both potential benefits and adverse effects of corticosteroids in patients with septic shock. The results of this study will provide definitive data upon which to base future recommendations for corticosteroid administration in pediatric septic shock.
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