E.W. "Al" Thrasher
Status: Funded - Open
BACKGROUND: Septic shock in children is a leading cause of morbidity and mortality globally. Mainstays of treatment for septic shock include administration of fluids, antibiotics and vasoactive/inotropic medications. Despite these therapies, the morbidity and mortality of pediatric septic shock remain high leading to the need for additional therapies such as corticosteroids. GAP: The role of corticosteroids in pediatric septic shock has not been studied in rigorous trials and remains unclear. Furthermore, very small numbers of children from Asia have been included in the limited trials that have been conducted HYPOTHESIS: Hydrocortisone will decrease the proportion of children with a poor outcome, defined as death or ≥ 25% decrease from baseline in health-related quality of life (HRQL) at 28 days. Hydrocortisone will decrease the proportion of patients who develop new multiple organ dysfunction syndrome (MODS), or in whom MODS worsens by one or more organ dysfunction(s) by 28 days METHODS: This is a multi-center, double-blind, randomized controlled trial (RCT) of corticosteroids [an initial bolus of 2 mg/kg IV hydrocortisone (maximum of 100 mg), followed by 1 mg/kg (maximum 50 mg) of hydrocortisone dosed every six hours] or placebo for a maximum of seven days or until all blood pressure supporting infusions have been discontinued for at least 12 hours. All children (28 days – 17 years and 8 months of age) with septic shock who require infusion of ≥ 2 medications to support their blood pressure at any dose, or epinephrine or norepinephrine alone at ≥ 0.1mcg/kg/min for ≥ 1 hour to maintain stable blood pressure. RESULTS: Pending. IMPACT: Corticosteroids are widely available, inexpensive and easy to administer even in under-resourced settings but their effectiveness in septic shock in children has never been studied in a rigorous RCT. The results of this trial will be useful regardless of the findings; if a beneficial effect of corticosteroids is identified, this will guide practice; if no benefit is demonstrated, this will prevent needless or potentially harmful use of corticosteroids. Website Link: https://shipss.org/Optional/Additional Comments: SHIPSS-Asia, together with the parent study, SHIPPS, will be the first inter-continental RCT of corticosteroids in pediatric septic shock powered to find a statistically significant difference in patient centered outcomes.