SHIPPS

Summary

Septic shock accounts for approximately 8% of pediatric intensive care unit (PICU) admissions worldwide, carries significant morbidity and has a reported mortality rate between 5% and 40% depending on the setting in which it occurs. Important parts of treatment involve early administration of antibiotics, fluids and medications to improve blood pressure. However, the high morbidity and mortality of pediatric septic shock have led physicians to consider corticosteroids when patients do not stabilize following initial management. Although the use of corticosteroids in septic shock has been widely debated in the literature for over 40 years, there is no clear evidence for or against this practice. Some pediatric studies have reported an improvement in blood pressure and organ function with the use of corticosteroids while other studies have suggested an increase in secondary infections, blood sugar and a decreased ability to fight infection. We therefore plan to conduct a randomized controlled trial to determine if hydrocortisone (a corticosteroid) compared to placebo improves outcomes (as measured by mortality and quality of life) in children with septic shock. This study will be conducted in 1032 patients in 30 centres across Canada and the US over 4 years. Eligible children will include those from age 1 month to 17.5 years, with evidence of a severe infection and need for medications to support their blood pressure. We will also compare organ function, potential side effects and healthcare costs in the hydrocortisone and placebo groups. Our study will be the first pediatric septic shock trial that is large enough to assess the potential benefits of corticosteroids in this patient population. We will also be the first adult or pediatric trial to assess the effect of a treatment for septic shock on quality of life. The results of this study will provide evidence on which to base recommendations for corticosteroid administration in pediatric septic shock.