NCT04545424 · University of Maryland, Baltimore
Trial of Therapeutic Hypothermia in Patients With ARDS
(CHILL)
What this study is about
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.
View original scientific description
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.
Interventions
DEVICE
Hypothermia
Subjects will be cooled using either cooling blankets or gel-pad systems to maintain core temperature 34-35°C.
DRUG
Neuromuscular Blocking Agents
Subjects in the TH + NMB arm will be deeply sedated using agents at the discretion of the primary ICU team, then start continuous iv infusion of either cisatracurium, atracurium, or vecuronium titrated to 2 twitches on train of four monitoring and further titrated to ablate visible shivering.
DEVICE
Standard of care
Subjects who are hypothermic (≤36°C) during CRRT will receive surface warming to restore core temperature to 37°C. Patients with core temperature \>38°C will receive 650 mg acetaminophen and, if temperature remains \>38°C, surface cooling will be initiated to return core temperature to 37-38°C.
Primary outcome measures
28-day ventilator-free days (VFDs)
Time frame: Calculated at study day 28 or death (whichever occurs first)
Total number of days alive and not on a ventilator in the first 28 days after enrollment
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 ex
Where
- Los Angeles, California
- New Haven, Connecticut
- Atlanta, Georgia
- Chicago, Illinois
- Lexington, Kentucky
- Baltimore, Maryland
- Detroit, Michigan
- Camden, New Jersey
- Cincinnati, Ohio
- Cleveland, Ohio
- Portland, Oregon
- Philadelphia, Pennsylvania
And 3 more locations — see the full list below.
Collaborators
US Department of Veterans Affairs Cooperative Studies Program, KAI Research, United States Department of Defense
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 10, 2025 · Source of record for eligibility and locations