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

  •  
  • Overview
  •  
  • Research
  •  
  • Identity
  •  
  • Additional Document Info
  •  
  • View All
  •  

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/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: ClinicalTrials.gov: NCT02044159.

authors

  • O’Hearn, Katharine
  • McNally, Dayre
  • Choong, Karen Li-mei
  • Acharya, Anand
  • Wong, Hector R
  • Lawson, Margaret
  • Ramsay, Tim
  • McIntyre, Lauralyn
  • Gilfoyle, Elaine
  • Tucci, Marisa
  • Wensley, David
  • Gottesman, Ronald
  • Morrison, Gavin
  • Menon, Kusum

publication date

  • December 2016

has subject area