The Evolution of COOL over COVID and other World Crises

The initial protocol for the COOL trial envisioned multiple nested studies examining all aspects of OA management, of which an adequately powered trial of mortality was the centerpiece [1]. Thus, any hospital providing emergency surgical services with intensive care support can participate if they are committed to recruit and randomize patients with SCIAS fulfilling the eligibility criteria during source control laparotomies. Contributing toward this main outcome will require only collection of the clinical outcome data. Prospective sub-studies that were envisioned to augment this main goal included COOL-Max (Bio-mediators), COOL-Mic (Microbiology), COOL-Cells (cellular defense mechanism), and COOL-Costs (economics). After the initiation of the clinical COOL trial, it became apparent that realistic operational demands and economic limitations precluded the conduct of these sub-studies, although a retrospective COOL trial economic analysis of open versus closed treatment is still a practical future analysis [73]. Thus, the dedicated focus of the current COOL trial efforts is completing the clinical outcome analysis powered on mortality.