ventila-A Randomized Controlled Trial of Corticosteroids in Pediatric Septic Shock: A Pilot Feasibility Study*

from the NIH. Dr. Lawson’s institution received funding from CIHR. Dr. Gil- foyle’s institution received funding from CHEO Research Institute (origi-nal funder CIHR), Alberta Innovates Health Solutions, Alberta Children’s Hospital Foundation, CIHR, Heart and Stroke Foundation, Alberta Health Services, and Centre Hospitalier Universitaire Sainte-Justine. Mr. Wensley disclosed: expenses for the study were covered by the CIHR grant (i.e., pharmacy and laboratory costs). He received support for article research from CIHR. Dr. Gottesman’s institution received funding from CIHR. He received support for article research from CIHR. Dr. Morrison’s institu- tion received funding from CHEO. He disclosed off-label product use: hydrocortisone use in children with septic shock. Mrs. Choong’s institution received funding from CIHR to support research personnel in the enrollment and data collection and from Academic Health Sciences Innovation Grant. She has disclosed that she is employed by McMaster University and Hamilton Health Sciences. The remaining authors have disclosed that they do not have any potential conflicts of interest. and placebo groups, respectively) were included in the final analysis. The mean time from screening to randomization was 2.4 ± 2.1 hours and from screening to first dose of study drug was 3.8 ± 2.6 hours. Forty-two percent of potentially eligible patients (73/174) received corticosteroids prior to randomization: 38.5% (67/174) were already on corticosteroids for shock at the time of screening, and in 3.4% (6/174), the treating physician wished to administer corticosteroids. Six of 49 randomized patients (12.2%) received open-label steroids, three in each of the hydrocortisone and placebo groups. Time on vasopressors, days on mechanical ventila-A tion, PICU and hospital length of stay, and the rate of adverse events were not statistically different between the two groups. Conclusions: This study suggests that a large randomized controlled trial on early use of corticosteroids in pediatric septic shock is potentially feasible. However, the frequent use of empiric corticosteroids in otherwise eligible patients remains a significant challenge. Knowledge translation activities, targeted recruitment, and alternative study designs are possible strategies to mitigate this challenge. ( Pediatr Crit Care Med 2017; 18:505–512)