Cooling to Help Injured Lungs (CHILL) Phase IIB Randomized Control Trial of Therapeutic Hypothermia in Patients with ARDS

The major objective of the proposed study is to test for the first time in a randomized control trial (RCT) the hypothesis that early treatment with therapeutic hypothermia (TH) along with neuromuscular blockade (NMB), to prevent compensatory shivering, will be beneficial for patients with Acute Respiratory Distress Syndrome (ARDS). The strategy of this Phase IIb RCT is to compare TH plus NMB vs. usual temperature management in patients with ARDS and PaO2/FIO2 ratio (P/F) ≤200). The hypothesis is supported empirically by the results of in vitro and animal studies and two small clinical studies. TH has a theoretical advantage over existing therapies because it may act through multiple mechanisms. If shivering is blocked by co- treatment with NMB, overall metabolism and the requirement for pulmonary gas exchange are reduced by ~10% for each 1°C decrease in core temperature 1. Thus, TH can confer a benefit similar to ECMO by reducing the requirement for mechanical ventilation, but with lower cost and risk than ECMO and with less requirement for specialized equipment and expertise.