Trial of Therapeutic Hypothermia in Patients With ARDS
Status:
Recruiting
Trial end date:
2024-06-30
Target enrollment:
Participant gender:
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. Since COVID-19 is currently the most common cause of ARDS,
randomization will be stratified on COVID-19 status and patients with COVID-19 limited to no
more than one-third of budgeted enrollment per year. 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.
Phase:
Phase 2
Details
Lead Sponsor:
University of Maryland, Baltimore
Collaborators:
KAI Research United States Department of Defense US Department of Veterans Affairs Cooperative Studies Program