Actively Recruiting
Trial of Therapeutic Hypothermia in Patients With ARDS
Led by University of Maryland, Baltimore · Updated on 2025-11-10
340
Participants Needed
19
Research Sites
278 weeks
Total Duration
On this page
Sponsors
U
University of Maryland, Baltimore
Lead Sponsor
U
US Department of Veterans Affairs Cooperative Studies Program
Collaborating Sponsor
AI-Summary
What this Trial 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. 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
Official Title
Trial of Therapeutic Hypothermia in Patients With ARDS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient has an endotracheal tube or tracheostomy and has been mechanically ventilated for 7 days or less
- Patient is admitted to a participating intensive care unit (ICU)
- Chest imaging shows bilateral lung infiltrates not explained by pleural effusions, atelectasis, or fluid overload
- PaO2/FiO2 ratio is 200 or less with PEEP of 8 cm H2O or higher, confirmed within 72 hours of enrollment
- Access to a legally authorized representative to provide consent
- ARDS criteria (lung infiltrates and low oxygenation) occurred within 7 days of exposure to a known ARDS risk factor such as sepsis, pneumonia, or COVID-19
- Patients meeting all criteria except low oxygen ratio may be enrolled and monitored for later randomization if oxygen worsens within 72 hours
- Patients on high flow nasal oxygen or non-invasive ventilation may consent but must be intubated before enrollment
You will not qualify if you...
- Patient's ARDS moderate to severe window has passed (more than 72 hours since criteria met)
- Patient has missed the neuromuscular blocking agent window (more than 48 hours)
- Patient has been on mechanical ventilation for more than 7 days
- Patient has refractory low blood pressure requiring high doses of vasopressors
- Core body temperature below 35°C for 6 hours or more (not on continuous renal replacement therapy) on day of randomization
- Significant active bleeding requiring 3 or more blood transfusions or intervention on day of randomization
- Platelet count below 10,000 per mm3 on day of randomization
- Active blood cancer with expected survival less than 6 months
- Skin condition preventing use of cooling devices
- Patient is moribund or unlikely to survive 72 hours
- Pre-existing condition making survival beyond 28 days unlikely
- Do Not Resuscitate order at randomization (except full support for cardiac arrest)
- Not expected to remain intubated for at least 48 hours
- Physician unwilling to enroll patient
- Severe chronic lung disease including need for home oxygen above 2 LPM or BIPAP use (except for sleep apnea), or prior lung transplant
- Patient is pregnant at randomization
- Body mass index consistently above 50 kg/m2
- Severe heart failure (New York Heart Association class IV)
- Recent acute coronary syndrome or cardiac arrest within 30 days with expected poor outcomes
- Burns covering more than 20% of body surface
- Previous enrollment in this study
- Participation in another inpatient interventional trial started during current hospitalization
- Currently receiving extracorporeal membrane oxygenation (ECMO) during this hospitalization
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 19 locations
1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Not Yet Recruiting
2
Yale University
New Haven, Connecticut, United States, 06520
Terminated
3
Emory University
Atlanta, Georgia, United States, 30322
Actively Recruiting
4
Rush University Medical Center
Chicago, Illinois, United States, 60612
Actively Recruiting
5
Loyola University Chicago
Chicago, Illinois, United States, 60660
Terminated
6
University of Kentucky
Lexington, Kentucky, United States, 40536
Not Yet Recruiting
7
University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
Actively Recruiting
8
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21205
Terminated
9
Henry Ford Hospital
Detroit, Michigan, United States, 48202
Actively Recruiting
10
Cooper Health System
Camden, New Jersey, United States, 08103
Actively Recruiting
11
University of Cincinnati
Cincinnati, Ohio, United States, 45219
Actively Recruiting
12
Cleveland Clinc
Cleveland, Ohio, United States, 44195
Actively Recruiting
13
Oregon Health & Science University
Portland, Oregon, United States, 97239
Actively Recruiting
14
University of Pennsylavia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
15
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
16
Temple University
Philadelphia, Pennsylvania, United States, 19140
Actively Recruiting
17
Brooke Army Medical Center
Fort Sam Houston, Texas, United States, 78234
Terminated
18
Intermountain Healthcare (Utah)
Salt Lake City, Utah, United States, 84132
Actively Recruiting
19
University of Wisconsin
Madison, Wisconsin, United States, 53792
Terminated
Research Team
C
Carl B Shanholtz, MD
CONTACT
M
Michael L Terrin, MD/MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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