Condition: Respiratory Distress Syndrome, Adult · Sponsor: University of Maryland, Baltimore
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 b…
This description comes directly from the study's public registry record.
Carl B Shanholtz, MD · 410-328-8141 · cshanhol@som.umaryland.edu
Michael L Terrin, MD/MPH · 410-706-6139 · mterrin@som.umaryland.edu
Always discuss trial participation with your own doctor first.
| Cedars-Sinai Medical Center | Los Angeles, California, United States | Not Yet Recruiting |
| Yale University | New Haven, Connecticut, United States | Terminated |
| Emory University | Atlanta, Georgia, United States | Recruiting |
| Rush University Medical Center | Chicago, Illinois, United States | Recruiting |
| Loyola University Chicago | Chicago, Illinois, United States | Terminated |
| University of Kentucky | Lexington, Kentucky, United States | Not Yet Recruiting |
| University of Maryland Medical Center | Baltimore, Maryland, United States | Recruiting |
| Johns Hopkins Hospital | Baltimore, Maryland, United States | Terminated |
| Henry Ford Hospital | Detroit, Michigan, United States | Recruiting |
| Cooper Health System | Camden, New Jersey, United States | Recruiting |
| University of Cincinnati | Cincinnati, Ohio, United States | Recruiting |
| Cleveland Clinc | Cleveland, Ohio, United States | Recruiting |
+ 7 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT04545424