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Steroids in fluid and/or vasoactive infusion dependent pediatric shock: study protocol for a randomized controlled trial O’Hearn, Katharine; McNally, Dayre; Choong, Karen; Acharya, Anand; Wong, Hector R; Lawson, Margaret; Ramsay, Tim; McIntyre, Lauralyn; Gilfoyle, Elaine; Tucci, Marisa; et al.

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

Item Metadata

Title
Steroids in fluid and/or vasoactive infusion dependent pediatric shock: study protocol for a randomized controlled trial
Creator
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
Publisher
BioMed Central
Date Issued
2016-05-06
Description
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
Subject
Hydrocortisone; Pediatric Intensive Care Unit; Legal Guardian; Dengue Shock Syndrome; Pediatric Intensive Care Unit Admission
Genre
Article
Type
Text
Language
eng
Date Available
2018-05-16
Provider
Vancouver : University of British Columbia Library
Rights
Attribution 4.0 International (CC BY 4.0)
DOI
10.14288/1.0366903
URI
http://hdl.handle.net/2429/65959
Affiliation
Medicine, Faculty of; Non UBC; Pediatrics, Department of
Citation
Trials. 2016 May 06;17(1):238
Publisher DOI
10.1186/s13063-016-1365-6
Peer Review Status
Reviewed
Scholarly Level
Faculty
Copyright Holder
O’Hearn et al.
Rights URI
http://creativecommons.org/licenses/by/4.0/
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Attribution 4.0 International (CC BY 4.0)