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

• Published in: Current controlled trials in cardiovascular medicine 2016-05, Vol.17 (1), p.238-238, Article 238
• Main Authors: O'Hearn, Katharine, McNally, Dayre, Choong, Karen, Acharya, Anand, Wong, Hector R, Lawson, Margaret, Ramsay, Tim, McIntyre, Lauralyn, Gilfoyle, Elaine, Tucci, Marisa, Wensley, David, Gottesman, Ronald, Morrison, Gavin, Menon, Kusum
• Format: Article
• Language: English
• Subjects: Administration, Intravenous; Adrenal Cortex Hormones - administration & dosage; Adrenal Cortex Hormones - adverse effects; Age Factors; Biomarkers - blood; Canada; Clinical Protocols; Clinical trials; Combined Modality Therapy; Complications and side effects; Consent; Corticosteroids; Critical care; Dosage and administration; Double-Blind Method; Drug dosages; Drug therapy; Enrollments; Feasibility Studies; Fluid Therapy - adverse effects; Fluid Therapy - mortality; Heart surgery; Hospitals; Humans; Hydrocortisone - administration & dosage; Hydrocortisone - adverse effects; Hydrocortisone - blood; Infusions, Parenteral; Intensive care; Mortality; Observational studies; Patients; Pediatrics; Pilot Projects; Research Design; Shock; Shock, Septic - diagnosis; Shock, Septic - drug therapy; Shock, Septic - mortality; Shock, Septic - physiopathology; Steroids; Study Protocol; Time Factors; Treatment Outcome; Vasoconstrictor Agents - administration & dosage; Vasoconstrictor Agents - adverse effects
• ISSN: 1745-6215; 1745-6215
• DOI: 10.1186/s13063-016-1365-6

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. 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. 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. ClinicalTrials.gov: NCT02044159.