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Chilling the body to save the lungs: new trial for ARDS

NCT ID NCT04545424

Disease control Sponsor: University of Maryland, Baltimore Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Sep 09, 2026 · Updated 2 times

Summary

This study tests whether gently cooling the body (to 34-35°C) combined with muscle-paralyzing drugs can help people with severe lung injury (ARDS) recover. About 340 adults on ventilators will be randomly assigned to cooling plus paralytics or usual care. The main goal is to see if cooling increases the number of days alive and off a ventilator within 28 days.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
therapeutic hypothermia (cooling blankets or gel-pads) and neuromuscular blocking agents (paralytics)
What this could lead to
If it works, this could point toward a new treatment that helps ARDS patients recover faster and spend less time on a ventilator.
What could go wrong
This is an early Phase 2 trial, so results may not be conclusive. Cooling can cause shivering, which requires deep sedation and paralysis, and the added risks of those drugs must be weighed.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 340 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2021

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. endotracheal tube or tracheostomy in place and mechanically ventilated for ≤7 days; 2. admitted to a participating ICU 3. radiologic evidence of bilateral pulmonary infiltrates not fully explained by pleural effusions, atelectasis, or hydrostatic pulmonary edema 4. P/F ratio ≤200 with PEEP ≥8 cm H2O; If ABG values are not available, the P/F ratio may be inferred from SpO2 values based on Table 3 from Brown et al as long as following conditions are met: 1. SpO2 values are 80-96% 2. SpO2 is measured ≥10 min after any change in FIO2 3. PEEP is ≥ 8 cm H2O 4. the pulse oximeter waveform tracing is adequate 5. the qualifying inferred P/F ratio is confirmed 1-6h after initial determination. 5. access to an LAR to provide consent. 6. Criteria 3 AND 4 must be met within 72h of enrollment and randomization, not be fully explained by hydrostatic pulmonary edema, and must have occurred within 7 days of exposure to an ARDS-risk factor (including continuous exposure to persistent processes (e.g. sepsis, pneumonia, COVID-19). * Patients may be enrolled and decision about randomization delayed if all criteria other than P/F ratio ≤ 200 are met and then randomized if and when the P/F ratio ≤200 (as long as this occurs within 72h of randomization). Patients on high flow nasal oxygen or non-invasive pressure ventilation may be consented if they meet criteria for starting the 72h ARDS window but may not be enrolled and randomized until they are intubated. Exclusion Criteria: 1. Missed moderate-severe ARDS window (\>72hrs) - Window starts when patient is intubated with a qualifying P/F ratio of ≤ 200 with PEEP ≥ 8 cm H2O or on high flow nasal oxygen with well-fitting nasal cannula with flow ≥ 40 LPM and FiO2 ≥ 0.65 or on non-invasive pressure ventilation with PEEP ≥ 8 cm H2O and FiO2 ≥ 0.6. 2. Missed NMB window: (\>48 hrs) 3. Missed mechanical ventilation window (\>7 days) 4. Refractory hypotension (continuous infusion of \>0.3 mcg/kg/min of norepinephrine or equivalent dose of other vasopressors within 2 hours prior to randomization) 5. Core temperature \<35°C for ≥6 hours while not receiving CRRT on day of randomization 6. Significant, active bleeding (\>3u blood products and/or surgical/IR intervention) on day of randomization 7. Platelets \<10K/mm3 (uncorrected) on day of randomization 8. Active hematologic malignancy and not expected to survive 6 months 9. Skin process that precludes cooling device 10. Moribund, not likely to survive 72h 11. Pre-morbid condition makes it unlikely that patient will survive 28 days 12. Do Not Resuscitate status at time of randomization (excluding patients receiving full support EXCEPT CPR for cardiac arrest) 13. Not likely to remain intubated for ≥48h 14. Physician of record unwilling to participate 15. Severe underlying lung disease 1. Needs \> 2 LPM or \>28% continuous home O2 (adjusted for altitude) 2. On BIPAP (except for OSA) 3. Prior lung transplantation 16. Pregnant at time of randomization 17. BMI consistently \>50 kg/m2 18. Known NYHA class IV heart disease 19. Acute Coronary Syndrome (MI, unstable angina) within 30 days of randomization 20. Cardiac arrest within 30 days of randomization with sequelae likely to increase mortality and/or time to ventilator liberation. 21. Burns over \>20% of the body surface 22. Severe chronic liver disease (Child-Pugh score 12-15) 23. Previously randomized in CHILL study 24. Simultaneous enrollment in another inpatient interventional trial started during the current hospitalization. 25. On ECMO during the current hospitalization.

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Conditions

The condition(s) this trial relates to.

acute lung injury acute respiratory distress syndrome adult acute respiratory distress syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Respiratory distress syndrome, adult

Contacts and locations

Locations

  • Brooke Army Medical Center

    Fort Sam Houston, Texas, 78234, United States

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048, United States

  • Cleveland Clinc

    Cleveland, Ohio, 44195, United States

  • Cooper Health System

    Camden, New Jersey, 08103, United States

  • Emory University

    Atlanta, Georgia, 30322, United States

  • Henry Ford Hospital

    Detroit, Michigan, 48202, United States

  • Intermountain Healthcare (Utah)

    Salt Lake City, Utah, 84132, United States

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21205, United States

  • Loyola University Chicago

    Chicago, Illinois, 60660, United States

  • Oregon Health & Science University

    Portland, Oregon, 97239, United States

  • Rush University Medical Center

    Chicago, Illinois, 60612, United States

  • Temple University

    Philadelphia, Pennsylvania, 19140, United States

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107, United States

  • University of Cincinnati

    Cincinnati, Ohio, 45219, United States

  • University of Kentucky

    Lexington, Kentucky, 40536, United States

  • University of Maryland Medical Center

    Baltimore, Maryland, 21201, United States

  • University of Pennsylavia

    Philadelphia, Pennsylvania, 19104, United States

  • University of Wisconsin

    Madison, Wisconsin, 53792, United States

  • Yale University

    New Haven, Connecticut, 06520, United States

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