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Published in: Trials 1/2016

Open Access 01-12-2016 | Study protocol

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

Authors: Katharine O’Hearn, Dayre McNally, Karen Choong, Anand Acharya, Hector R. Wong, Margaret Lawson, Tim Ramsay, Lauralyn McIntyre, Elaine Gilfoyle, Marisa Tucci, David Wensley, Ronald Gottesman, Gavin Morrison, Kusum Menon, On behalf of the Canadian Critical Care Trials Group

Published in: Trials | Issue 1/2016

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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
Appendix
Available only for authorised users
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Metadata
Title
Steroids in fluid and/or vasoactive infusion dependent pediatric shock: study protocol for a randomized controlled trial
Authors
Katharine O’Hearn
Dayre McNally
Karen Choong
Anand Acharya
Hector R. Wong
Margaret Lawson
Tim Ramsay
Lauralyn McIntyre
Elaine Gilfoyle
Marisa Tucci
David Wensley
Ronald Gottesman
Gavin Morrison
Kusum Menon
On behalf of the Canadian Critical Care Trials Group
Publication date
01-12-2016
Publisher
BioMed Central
Published in
Trials / Issue 1/2016
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-016-1365-6

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