Evidence map›Paper›PMID 27153945›Full record

Trial reportTrials2016

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

Katharine O'Hearn, Dayre McNally, Karen Choong, Anand Acharya, Hector R Wong, Margaret Lawson, Tim Ramsay, Lauralyn McIntyre, Elaine Gilfoyle, Marisa Tucci and 5 more

Registry-linked trialOpen access · goldAbstract readMulticenter StudyPragmatic Clinical TrialRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Trials, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02044159 (Steroid Use in Pediatric Fluid and Vasoactive Infusion Dependent Shock - Pilot Study), which is not on this map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
2.5field-weighted citation impact, top 11% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02044159 phase4completednot on this map

Steroid Use in Pediatric Fluid and Vasoactive Infusion Dependent Shock - Pilot Study (STRIPES)

TypeinterventionalSponsorChildren's Hospital of Eastern OntarioRan2014 to 2016Enrolled57ConditionsShockArmsHydrocortisone, Placebo
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 13 citations in OpenAlex.

  1. Guideline
  2. A Randomized Controlled Trial of Corticosteroids in Pediatric Septic Shock: A Pilot Feasibility Study.Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies · 2017
    Trial
  3. Review
  4. Pragmatic Pediatric Trial of Balanced Versus Normal Saline Fluid in Sepsis: The PRoMPT BOLUS Randomized Controlled Trial Pilot Feasibility Study.Academic emergency medicine : official journal of the Society for Academic Emergency Medicine · 2019
    Article
  5. Hydrocortisone Therapy in Catecholamine-Resistant Pediatric Septic Shock: A Pragmatic Analysis of Clinician Practice and Association With Outcomes.Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies · 2017
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors at 7 institutions in 2 countries.

Katharine O'HearnResearch Institute, Children's Hospital of Eastern Ontario, Ottawa, Canada. kohearn@cheo.on.ca.
Dayre McNallyResearch Institute, Children's Hospital of Eastern Ontario, Ottawa, Canada.
Karen ChoongMcMaster Children's Hospital, McMaster University, Hamilton, Canada.
Anand AcharyaDepartment of Economics, Faculty of Public Affairs, Carleton University, Ottawa, Canada.
Hector R WongCincinnati Children's Hospital Medical Center, University of Cincinnati College of Medicine, Cincinnati, USA.
Margaret LawsonResearch Institute, Children's Hospital of Eastern Ontario, Ottawa, Canada.
Tim RamsayDepartment of Epidemiology, University of Ottawa and Ottawa Hospital Research Institute (OHRI), University of Ottawa, Ottawa, Canada.
Lauralyn McIntyreDepartment of Medicine (Division of Critical Care), Ottawa Hospital Research Institute (OHRI), University of Ottawa, Ottawa, Canada.
Elaine GilfoyleSection of Critical Care Medicine, Department of Pediatrics, Alberta Children's Hospital, Calgary, Canada.
Marisa TucciDepartment of Pediatrics, CHU Sainte-Justine Hospital, Montreal, Canada.
David WensleyDepartment of Pediatrics, Faculty of Medicine, The University of British Columbia, British Columbia Children's Hospital, Vancouver, Canada.
Ronald GottesmanDepartment of Pediatrics, Faculty of Medicine, McGill University, Montreal Children's Hospital, Montreal, Canada.
Gavin MorrisonDepartment of Critical Care Medicine, IWK Health Centre, Halifax, Canada.
Kusum MenonResearch Institute, Children's Hospital of Eastern Ontario, Ottawa, Canada.
Canadian Critical Care Trials Group
University of Ottawa · CAChildren's Hospital of Eastern Ontario · CACincinnati Children's Hospital Medical Center · USMontreal Children's Hospital · CAAlberta Children's Hospital · CAMcMaster Children's Hospital · CAUniversity of British Columbia · CA

Funding

Canadian Institutes of Health Research
6 · The paper itself

Abstract

backgroundPhysicians 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/

designSteroids 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 registrationClinicalTrials.gov: NCT02044159.

Indexed as

Fluid TherapyAdministration, IntravenousAdrenal Cortex HormonesAge FactorsBiomarkersCanadaClinical ProtocolsCombined Modality TherapyDouble-Blind MethodFeasibility StudiesHumansHydrocortisoneInfusions, ParenteralPilot ProjectsResearch DesignShock, SepticAdrenal Cortex HormonesBiomarkersHydrocortisoneVasoconstrictor Agents

Identifiers

PMID27153945
PMCPMC4859989
OpenAlexW2345416096

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.