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 Phae 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 34-35C 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 first year we completed the study protocol and manual of operations, the paper case report forms, the electronic data capture and randomization program, adverse even reporting plan, clinical monitoring plan, the sample collection, labelling, and inventory system. 11 of 14 sites are IRB-approved, DoD HRPO-approved, had site initiation visits, and have started screening. Two other sites are addressing queries from the central IRB prior to approval and one site is finalizing approval from their local IRB. Screening has commenced at five sites and the first patient was enrolled and randomized.
Document Details
- Document Type
- Technical Report
- Publication Date
- Jul 01, 2021
- Accession Number
- AD1153325
Entities
People
- Jeffrey D Hasday
Organizations
- University of Maryland, Baltimore