Evidence map›Paper›PMID 31855716›Full record

ArticleAmerican heart journal2020

Rationale and design of the STeroids to REduce Systemic inflammation after infant heart Surgery (STRESS) trial.

Kevin D Hill, H Scott Baldwin, David P Bichel, Ryan J Butts, Reid C Chamberlain, Alicia M Ellis, Eric M Graham, Jesse Hickerson, Christoph P Hornik, Jeffrey P Jacobs and 8 more

Open access · greenAbstract readClinical Trial Protocol
In one paragraph

Article in American heart journal, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
15citing papers in PubMed, 2 pooled it
3.4field-weighted citation impact, top 7% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

15 citing papers in PubMed, 2 syntheses or guidelines pooled it, 42 citations in OpenAlex.

  1. Pooled it
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  4. A Bayesian re-analysis of the STRESS trial.American heart journal · 2026
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

18 authors at 8 institutions in 1 country.

Kevin D HillDuke University Pediatric and Congenital Heart Center, Durham, NC; Duke Clinical Research Institute, Durham, NC.
H Scott BaldwinVanderbilt University Medical Center, Nashville, TN.
David P BichelVanderbilt University Medical Center, Nashville, TN.
Ryan J ButtsUniversity of Texas Southwestern, Dallas, TX.
Reid C ChamberlainDuke University Pediatric and Congenital Heart Center, Durham, NC.
Alicia M EllisDuke Clinical Research Institute, Durham, NC.
Eric M GrahamMedical University of South Carolina, Charleston, SC.
Jesse HickersonDuke Clinical Research Institute, Durham, NC.
Christoph P HornikDuke University Pediatric and Congenital Heart Center, Durham, NC; Duke Clinical Research Institute, Durham, NC.
Jeffrey P JacobsJohns Hopkins University School of Medicine, Baltimore, MD.
Marshall L JacobsJohns Hopkins University School of Medicine, Baltimore, MD.
Robert Db JaquissUniversity of Texas Southwestern, Dallas, TX.
Prince J KannankerilVanderbilt University Medical Center, Nashville, TN.
Sean M O'BrienDuke Clinical Research Institute, Durham, NC.
Rachel TorokDuke University Pediatric and Congenital Heart Center, Durham, NC.
Joseph W TurekDuke University Pediatric and Congenital Heart Center, Durham, NC.
Jennifer S LiDuke University Pediatric and Congenital Heart Center, Durham, NC; Duke Clinical Research Institute, Durham, NC.
STRESS Network Investigators
Duke University Hospital · USVanderbilt University Medical Center · USClinical Research Institute · USThe University of Texas Southwestern Medical Center · USJohns Hopkins Medicine · USLurie Children's Hospital · USBaylor College of Medicine · USMedical University of South Carolina · US

Funding

COVID-19 Supplement - Center for Innovative TRIals in ChilDrEN and AdulTs (TRIDENT)U24TR001608 · NCATS · DUKE UNIVERSITY · PI BENJAMIN, DANIEL K., BERNARD, GORDON RAPHAEL · 2016 to 2022
$177.0M
Support for QA/QC for Prior Approval ProcessUL1TR002553 · NCATS · DUKE UNIVERSITY · PI LI, JENNIFER S, MCNAMARA, JAMES O. · 2018 to 2023
$58.5M
Leveraging existing registry resources to facilitate clinical trialsU01TR001803 · NCATS · DUKE UNIVERSITY · PI BALDWIN, H SCOTT, JACOBS, JEFFREY PHILLIP · 2016 to 2020
$5.5M
Global Pediatric Clinical Trials NetworkU18FD006298 · FDA · DUKE UNIVERSITY · PI COHEN-WOLKOWIEZ, MICHAEL, HORNIK, CHRISTOPH · 2017 to 2021
$5.5M
Pharmacokinetics, Pharmacodynamics, and Safety of Methylprednisolone in Neonates on Cardiopulmonary BypassK23HD090239 · NICHD · DUKE UNIVERSITY · PI HORNIK, CHRISTOPH · 2017 to 2020
$646k
FDA HHS U18 FD006298NCATS NIH HHS L40 TR002124NCATS NIH HHS U01 TR001803NCATS NIH HHS U24 TR001608NCATS NIH HHS UL1 TR002553NICHD NIH HHS HHSN267200700051CNICHD NIH HHS HHSN275201000003INICHD NIH HHS K23 HD090239
6 · The paper itself

Abstract

For decades, physicians have administered corticosteroids in the perioperative period to infants undergoing heart surgery with cardiopulmonary bypass (CPB) to reduce the postoperative systemic inflammatory response to CPB. Some question this practice because steroid efficacy has not been conclusively demonstrated and because some studies indicate that steroids could have harmful effects. STRESS is a randomized, placebo-controlled, double-blind, multicenter trial designed to evaluate safety and efficacy of perioperative steroids in infants (age < 1 year) undergoing heart surgery with CPB. Participants (planned enrollment = 1,200) are randomized 1:1 to methylprednisolone (30 mg/kg) administered into the CPB pump prime versus placebo. The trial is nested within the existing infrastructure of the Society of Thoracic Surgeons Congenital Heart Surgery Database. The primary outcome is a global rank score of mortality, major morbidities, and hospital length of stay with components ranked commensurate with their clinical severity. Secondary outcomes include several measures of major postoperative morbidity, postoperative hospital length of stay, and steroid-related safety outcomes including prevalence of hyperglycemia and postoperative infectious complications. STRESS will be one of the largest trials ever conducted in children with heart disease and will answer a decades-old question related to safety and efficacy of perioperative steroids in infants undergoing heart surgery with CPB. The pragmatic "trial within a registry" design may provide a mechanism for conducting low-cost, high-efficiency trials in a heretofore-understudied patient population.

Indexed as

Anti-Inflammatory AgentsCardiopulmonary BypassDouble-Blind MethodHeart Defects, CongenitalHumansHyperglycemiaInfantInfant, NewbornInfectionsLength of StayMethylprednisoloneMulticenter Studies as TopicOutcome Assessment, Health CarePlacebosPostoperative ComplicationsPragmatic Clinical Trials as TopicAnti-Inflammatory AgentsMethylprednisolonePlacebos

Identifiers

PMID31855716
PMCPMC7008076
OpenAlexW2996017122

What OpenQuestion holds

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Read underepoch 390

Registered trials

None linked

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.