Cooling to Help Injured Lungs (CHILL) Phase 2B Randomized Control Trial of Therapeutic Hypothermia in Patients with ARDS
Abstract
The objective of this project is to conduct a 14-site Phase IIb randomized controlled clinical trial to address the following specific aims: (1) analyze the potential lung protective effect of 48h treatment with mild therapeutic hypothermia (TH; core temperature 34 degree-35 degree C for 48h) and neuromuscular blockade (NMB) in 340 patients with ARDS and P/F 200 compared with controls receiving standard temperature management; (2) evaluate the effects of TH and NMB on systemic inflammation and extrapulmonary organ dysfunction; (3) analyze safety of TH and NMB in patients with ARDS. In the past year we opened 14 clinical and replaced two of these sites for poor performance. We screened 2325 patients and enrolled 38. We took multiple measures to improve enrollment, including replacing two poorly performing sites and evaluating additional sites for replacement, having multiple group and one-on-one meetings with personnel from lagging sites, made multiple changes in the study protocol to facilitate enrollment, added affiliated hospitals and additional units to existing sites, provided screening tools to facilitate screening and enrollment, and given invited talks at clinical sites to increase the profile of the CHILL trial.
Document Details
- Document Type
- Technical Report
- Publication Date
- Jul 01, 2022
- Accession Number
- AD1190405
Entities
People
- Jeffrey D Hasday
Organizations
- University of Baltimore