title: Steroids in fluid and/or vasoactive infusion dependent pediatric shock: study protocol for a randomized controlled trial.
abstract: 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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  ClinicalTrials.gov: NCT02044159.
authors.affiliation: Research Institute, Children's Hospital of Eastern Ontario, Ottawa, Canada. kohearn@cheo.on.ca.
authors.forename: Katharine
authors.initials: K
authors.lastname: O'Hearn
authors.affiliation: Research Institute, Children's Hospital of Eastern Ontario, Ottawa, Canada.|Department of Pediatrics, Faculty of Medicine, University of Ottawa, Children's Hospital of Eastern Ontario, Ottawa, Canada.
authors.forename: Dayre
authors.initials: D
authors.lastname: McNally
authors.affiliation: McMaster Children's Hospital, McMaster University, Hamilton, Canada.
authors.forename: Karen
authors.initials: K
authors.lastname: Choong
authors.affiliation: Department of Economics, Faculty of Public Affairs, Carleton University, Ottawa, Canada.
authors.forename: Anand
authors.initials: A
authors.lastname: Acharya
authors.affiliation: Cincinnati Children's Hospital Medical Center, University of Cincinnati College of Medicine, Cincinnati, USA.
authors.forename: Hector R
authors.initials: HR
authors.lastname: Wong
authors.affiliation: Research Institute, Children's Hospital of Eastern Ontario, Ottawa, Canada.|Department of Pediatrics, Faculty of Medicine, University of Ottawa, Children's Hospital of Eastern Ontario, Ottawa, Canada.
authors.forename: Margaret
authors.initials: M
authors.lastname: Lawson
authors.affiliation: Department of Epidemiology, University of Ottawa and Ottawa Hospital Research Institute (OHRI), University of Ottawa, Ottawa, Canada.|Clinical Epidemiology Program, The Ottawa Hospital Research Institute (OHRI), Ottawa, Canada.
authors.forename: Tim
authors.initials: T
authors.lastname: Ramsay
authors.affiliation: Department of Medicine (Division of Critical Care), Ottawa Hospital Research Institute (OHRI), University of Ottawa, Ottawa, Canada.
authors.forename: Lauralyn
authors.initials: L
authors.lastname: McIntyre
authors.affiliation: Section of Critical Care Medicine, Department of Pediatrics, Alberta Children's Hospital, Calgary, Canada.
authors.forename: Elaine
authors.initials: E
authors.lastname: Gilfoyle
authors.affiliation: Department of Pediatrics, CHU Sainte-Justine Hospital, Montreal, Canada.
authors.forename: Marisa
authors.initials: M
authors.lastname: Tucci
authors.affiliation: Department of Pediatrics, Faculty of Medicine, The University of British Columbia, British Columbia Children's Hospital, Vancouver, Canada.
authors.forename: David
authors.initials: D
authors.lastname: Wensley
authors.affiliation: Department of Pediatrics, Faculty of Medicine, McGill University, Montreal Children's Hospital, Montreal, Canada.
authors.forename: Ronald
authors.initials: R
authors.lastname: Gottesman
authors.affiliation: Department of Critical Care Medicine, IWK Health Centre, Halifax, Canada.
authors.forename: Gavin
authors.initials: G
authors.lastname: Morrison
authors.affiliation: Research Institute, Children's Hospital of Eastern Ontario, Ottawa, Canada.|Department of Pediatrics, Faculty of Medicine, University of Ottawa, Children's Hospital of Eastern Ontario, Ottawa, Canada.
authors.forename: Kusum
authors.initials: K
authors.lastname: Menon
mesh_terms: D061605:Administration, Intravenous; D000305:Adrenal Cortex Hormones / Q000008:administration & dosage* / Q000009:adverse effects; D000367:Age Factors; D015415:Biomarkers / Q000097:blood; D002170:Canada; D002985:Clinical Protocols; D003131:Combined Modality Therapy; D004311:Double-Blind Method; D005240:Feasibility Studies; D005440:Fluid Therapy / Q000009:adverse effects / Q000401:mortality; D006801:Humans; D006854:Hydrocortisone / Q000008:administration & dosage* / Q000009:adverse effects / Q000097:blood; D007263:Infusions, Parenteral; D010865:Pilot Projects; D012107:Research Design; D012772:Shock, Septic / Q000175:diagnosis / Q000188:drug therapy* / Q000401:mortality / Q000503:physiopathology; D013997:Time Factors; D016896:Treatment Outcome; D014662:Vasoconstrictor Agents / Q000008:administration & dosage* / Q000009:adverse effects
chemical_list: D000305:Adrenal Cortex Hormones; D015415:Biomarkers; D014662:Vasoconstrictor Agents; D006854:Hydrocortisone