Steroids in fluid and/or vasoactive infusion dependent pediatric shock: study protocol for a randomized controlled trial

dc.contributor.authorO’Hearn, Katharine
dc.contributor.authorMcNally, Dayre
dc.contributor.authorChoong, Karen
dc.contributor.authorAcharya, Anand
dc.contributor.authorWong, Hector R
dc.contributor.authorLawson, Margaret
dc.contributor.authorRamsay, Tim
dc.contributor.authorMcIntyre, Lauralyn
dc.contributor.authorGilfoyle, Elaine
dc.contributor.authorTucci, Marisa
dc.contributor.authorWensley, David
dc.contributor.authorGottesman, Ronald
dc.contributor.authorMorrison, Gavin
dc.contributor.authorMenon, Kusum
dc.identifier.citationTrials. 2016 May 06;17(1):238
dc.description.abstractAbstract Background Physicians often administer corticosteroids for the treatment of fluid and vasoactive infusion dependent pediatric shock. This use of corticosteroids is controversial, however, and has never been studied in a pediatric randomized controlled trial (RCT). This pilot trial will determine the feasibility of a larger RCT on the role of corticosteroids in pediatric shock. Methods/design Steroids in Fluid and/or Vasoactive Infusion Dependent Pediatric Shock (STRIPES) is a pragmatic, seven-center, double-blind, pilot RCT. We aim to randomize 72 pediatric patients with fluid and vasoactive infusion dependent shock to receive either hydrocortisone or a saline placebo for 7 days or until clinical stability, whichever occurs first. The primary outcome of this pilot trial is the feasibility of recruitment, defined as the number of patients enrolled over a 1-year period. Secondary outcomes include the frequency of, and reasons for, open-label steroid use, protocol adherence, incidence of mortality and corticosteroid-associated adverse events, time to discontinuation of inotropes, and feasibility of blood sampling. Discussion Corticosteroids are used for the treatment of pediatric shock without sufficient evidence to support this practice. While there is a scientific rationale and limited data supporting their use in this setting, there is also evidence from other populations suggesting potential harm. The STRIPES pilot study will assess the feasibility of a larger, much needed trial powered for clinically important outcomes. Trial registration NCT02044159
dc.titleSteroids in fluid and/or vasoactive infusion dependent pediatric shock: study protocol for a randomized controlled trial
dc.typeJournal Article
dc.rights.holderO’Hearn et al.
CollectionLibre accès - Publications // Open Access - Publications