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Trial of Therapeutic Hypothermia in Patients With ARDS
NCT04545424 · View on ClinicalTrials.gov ↗
Study Summary
Acute Respiratory Distress Syndrome (ARDS) is a serious condition that occurs as a complication of medical and surgical diseases, has a mortality of \~40%, and has no known treatment other than optimization of support. Data from basic research, animal models, and retrospective studies, case series, and small prospective studies suggest that therapeutic hypothermia (TH) similar to that used for cardiac arrest may be lung protective in patients with ARDS; however, shivering is a major complication of TH, often requiring paralysis with neuromuscular blocking agents (NMBA) to control. Since the recently completed NHLBI PETAL ROSE trial showed that NMBA had no effect (good or bad) in patients with moderate to severe ARDS, the CHILL trial is designed to evaluate whether TH combined with NMBA is beneficial in patients with ARDS. This Phase IIb randomized clinical trial is funded by the Department of Defense to compare TH (core temperature 34-35°C) + NMBA for 48h vs. usual temperature management in patients in 14 clinical centers with the Clinical Coordination Center and Data Coordinating Center at University of Maryland Baltimore. Planned enrollment is 340 over \~3.5 years of the 4-year contract. COVID-19 is considered an ARDS risk-factor and patients with ARDS secondary to COVID-19 pneumonia will be eligible for enrollment. Primary outcome is 28-day ventilator-free days. Secondary outcomes include safety, physiologic measures, mortality, hospital and ICU length of stay, and serum biomarkers collected at baseline and on days 1, 2, 3, 4, and 7.
Conditions Studied
Interventions
- DEVICE Hypothermia
- DRUG Neuromuscular Blocking Agents
- DEVICE Standard of care
Study Locations (19)
Pennsylvania
- University of Pennsylavia — Philadelphia
- Thomas Jefferson University — Philadelphia
- Temple University — Philadelphia
Illinois
- Rush University Medical Center — Chicago
- Loyola University Chicago — Chicago
Maryland
- University of Maryland Medical Center — Baltimore
- Johns Hopkins Hospital — Baltimore
Ohio
- University of Cincinnati — Cincinnati
- Cleveland Clinc — Cleveland
California
- Cedars-Sinai Medical Center — Los Angeles
Connecticut
- Yale University — New Haven
Georgia
- Emory University — Atlanta
Kentucky
- University of Kentucky — Lexington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 340 participants |
| Start Date | 2021-06-29 |
| Est. Completion | 2026-10-31 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04545424
The ClinicalTrials.gov registry entry for NCT04545424 describes a study currently listed as recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 340 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Maryland, Baltimore, which has 559 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Respiratory Distress Syndrome, Adult appearing as the primary indexed condition, and to 3 interventions — of which Hypothermia is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04545424 reports 19 study locations spanning 14 distinct geographic areas — top geographies include Pennsylvania, Illinois, Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04545424 about?
NCT04545424 is a clinical study titled "Trial of Therapeutic Hypothermia in Patients With ARDS". Acute Respiratory Distress Syndrome (ARDS) is a serious condition that occurs as a complication of medical and surgical diseases, has a mortality of \~40%, and has no known treatment other than optimization of support. Data from basic research, animal models, and retrospective studies, case series, ...
What is the current status of trial NCT04545424?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 340 participants. The study started on 2021-06-29. Estimated completion is 2026-10-31.
What conditions does trial NCT04545424 study?
This clinical trial studies the following conditions: Respiratory Distress Syndrome, Adult. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04545424?
The interventions under investigation include: Hypothermia (DEVICE), Neuromuscular Blocking Agents (DRUG), Standard of care (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04545424?
This trial is sponsored by University of Maryland, Baltimore, which has 559 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04545424 being conducted?
This trial has 19 study locations across California, Connecticut, Georgia, Illinois, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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