Grant: Project Grant

Septic shock accounts for up to 8% of pediatric intensive care unit (PICU) admissions worldwide, carries significant morbidity and has a mortality rate between 5% and 40% depending on the geographic region in which it occurs. Mainstays of treatment involve antibiotics, fluids and medications to improve blood pressure. However, the high morbidity and mortality of pediatric septic shock have led physicians to consider corticosteroids for unstable patients since corticosteroids are inexpensive and widely available. However, although the use of corticosteroids for septic shock has been widely debated 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 corticosteroids while other studies have suggested an increase in blood sugar and the inability 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 enroll 1032 patients in 30 centres across Canada and the US. Eligible children will include those from age 1 month to 17 years, with a severe infection and need for medications to support their blood pressure. We will exclude patients that have a known reason for receiving corticosteroids, who have malaria or a fungal infection and those who do not wish to participate. We will also assess 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 and the first 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.