At a glance
ClinicalIndex Comparison Record- ✓Endotracheal tube or tracheostomy in place and mechanically ventilated for ≤7 days
- ✓Admitted to a participating ICU
- ✓Bilateral pulmonary infiltrates not fully explained by pleural effusions, atelectasis, or hydrostatic pulmonary edema
- ✓P/F ratio ≤200 with PEEP ≥8 cm H2O
- ✕Missed moderate-severe ARDS window (>72 hours)
- ✕Missed NMB window (>48 hours)
- ✕Missed mechanical ventilation window (>7 days)
- ✕Refractory hypotension with >0.3 mcg/kg/min norepinephrine or equivalent within 2 hours prior to randomization
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Cooling to Help Injured Lungs (CHILL) Phase IIB Randomized Control Trial of Therapeutic Hypothermia in Patients With ARDS
In Brief
A Phase 2 clinical trial evaluating Hypothermia, Neuromuscular Blocking Agents, and 1 other intervention for Respiratory Distress Syndrome, Adult. Currently recruiting, targeting 340 participants across 19 sites.
Detailed 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. 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.
Study Details
Timeline
Interventions
Subjects will be cooled using either cooling blankets or gel-pad systems to maintain core temperature 34-35°C.
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.
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.