Evidence map›Paper›PMID 37228902›Full record

ArticleContemporary clinical trials communications2023

Design and rationale of the CHILL phase II trial of hypothermia and neuromuscular blockade for acute respiratory distress syndrome.

Carl B Shanholtz, Michael L Terrin, Thelma Harrington, Caleb Chan, Whittney Warren, Robert Walter, Faith Armstrong, Jeffrey Marshall, Rachel Scheraga, Abjihit Duggal and 11 more

Registry-linked trialOpen access · goldAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Contemporary clinical trials communications, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04545424 (Cooling to Help Injured Lungs), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
1.8field-weighted citation impact, top 14% 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.

NCT04545424 phase2recruitingnot on this map

Cooling to Help Injured Lungs (CHILL) Phase IIB Randomized Control Trial of Therapeutic Hypothermia in Patients With ARDS

TypeinterventionalSponsorUniversity of Maryland, BaltimoreRan2021 to 2026Enrolled340ConditionsRespiratory Distress Syndrome, AdultArmsHypothermia, Neuromuscular Blocking Agents, Standard of care
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 7 citations in OpenAlex.

  1. Article
  2. 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

21 authors at 13 institutions in 1 country.

Carl B ShanholtzDepartment of Medicine, University of Maryland School of Medicine, Baltimore, MD, USA.
Michael L TerrinDepartment of Epidemiology & Public Health, University of Maryland School of Medicine, Baltimore, MD, USA.
Thelma HarringtonDepartment of Medicine, University of Maryland School of Medicine, Baltimore, MD, USA.
Caleb ChanDepartment of Medicine, University of Maryland School of Medicine, Baltimore, MD, USA.
Whittney WarrenDepartment of Pulmonary and Critical Care Medicine, Brooke Army Medical Center, San Antonio, TX, USA.
Robert WalterDepartment of Pulmonary and Critical Care Medicine, Brooke Army Medical Center, San Antonio, TX, USA.
Faith ArmstrongBaltimore Washington Medical Center, Glen Burnie, MD, USA.
Jeffrey MarshallBaltimore Washington Medical Center, Glen Burnie, MD, USA.
Rachel ScheragaRespiratory Institute, Cleveland Clinic, Cleveland, OH, USA.
Abjihit DuggalRespiratory Institute, Cleveland Clinic, Cleveland, OH, USA.
Perry FormanekDepartment of Medicine, Loyola University Medical Center, Maywood, IL, USA.
Michael BaramDepartment of Medicine, Sidney Kimmel College of Medicine USA, Philadelphia, PA, USA.
Majid AfsharDepartment of Medicine, University of Wisconsin School of Medicine and Public Health, Madison, WI, USA.
Nathaniel MarchettiDepartment of Thoracic Medicine and Surgery, Lewis Katz School of Medicine at Temple University, Philadelphia, PA, USA.
Sunit SinglaDivision of Pulmonary, Critical Care, Sleep, and Allergy Medicine, University of Illinois at Chicago, Chicago, IL, USA.
John ReillyDepartment of Medicine, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA, USA.
Dan KnoxDivision of Pulmonary and Critical Care Medicine, Intermountain Medical Center, Murray, UT, USA.
Nitin PuriDivision of Critical Care, Cooper University Health Care, USA.
Kevin ChungDepartment of Medicine, F. Edward Hebert School of Medicine, Uniformed Services University of the Health Sciences, Bethesda, MD, USA.
Clayton H BrownDepartment of Epidemiology & Public Health, University of Maryland School of Medicine, Baltimore, MD, USA.
Jeffrey D HasdayDepartment of Medicine, University of Maryland School of Medicine, Baltimore, MD, USA.
University of Maryland, Baltimore · USBrooke Army Medical Center · USCleveland Clinic · USUniversity of Maryland Baltimore Washington Medical Center · USCooper University Health Care · USIntermountain Medical Center · USLoyola University Medical Center · USSidney Kimmel Cancer Center · USTemple University · USUniformed Services University of the Health Sciences · USUniversity of Illinois Chicago · USUniversity of Pennsylvania · USUniversity of Wisconsin–Madison · US

Funding

TRPV4 Regulates Mechanosensitive Macrophage Functions in Lung InjuryR01HL155064 · NHLBI · CLEVELAND CLINIC LERNER COM-CWRU · PI SCHERAGA, RACHEL GREENBERG · 2021 to 2025
$2.1M
Role of lung WWOX deficiency in vascular leak during lung injuryK08HL140222 · NHLBI · UNIVERSITY OF ILLINOIS AT CHICAGO · PI SINGLA, SUNIT · 2018 to 2022
$871k
NHLBI NIH HHS K08 HL140222NHLBI NIH HHS L30 HL159821NHLBI NIH HHS R01 HL155064
6 · The paper itself

Abstract

The Cooling to Help Injured Lungs (CHILL) trial is an open label, two group, parallel design multicenter, randomized phase IIB clinical trial assessing the efficacy and safety of targeted temperature management with combined external cooling and neuromuscular blockade to block shivering in patients with early moderate-severe acute respiratory distress syndrome (ARDS). This report provides the background and rationale for the clinical trial and outlines the methods using the Consolidated Standards of Reporting Trials guidelines. Key design challenges include: [1] protocolizing important co-interventions; [2] incorporation of patients with COVID-19 as the cause of ARDS; [3] inability to blind the investigators; and [4] ability to obtain timely informed consent from patients or legally authorized representatives early in the disease process. Results of the Reevaluation of Systemic Early Neuromuscular Blockade (ROSE) trial informed the decision to mandate sedation and neuromuscular blockade only in the group assigned to therapeutic hypothermia and proceed without this mandate in the control group assigned to a usual temperature management protocol. Previous trials conducted in National Heart, Lung, and Blood Institute ARDS Clinical Trials (ARDSNet) and Prevention and Early Treatment of Acute Lung Injury (PETAL) Networks informed ventilator management, ventilation liberation and fluid management protocols. Since ARDS due to COVID-19 is a common cause of ARDS during pandemic surges and shares many features with ARDS from other causes, patients with ARDS due to COVID-19 are included. Finally, a stepwise approach to obtaining informed consent prior to documenting critical hypoxemia was adopted to facilitate enrollment and reduce the number of candidates excluded because eligibility time window expiration.

Indexed as

Acute respiratory distress syndromeNeuromuscular blockadeRandomized controlled trialTherapeutic hypothermia

Identifiers

PMID37228902
PMCPMC10191700
OpenAlexW4377103647

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.