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Abstract
COOL-Lite, COOL-Max, COOL-Mic, COOL-Cells, and COOL-Costs The study will be powered to detect a mortality difference between the two allocated therapies which will be the most valuable deliverable of the study. [...]any dedicated site can participate if they are committed to recruit and randomize patients with SCIAS fulfilling the eligibility criteria during source control laparotomies. [...]in COOL-Costs, we will use information on survival (which can be extrapolated to life expectancy), quality of life, and health-care costs to conduct a full economic evaluation. [...]given a mortality rate of 33% in the general population of those with severe intra-abdominal sepsis, and considering a power of 80% and an alpha of 0.05, the number needed to recruit in each arm is 275 patients. Methodologic concerns with the peritoneal VAC trial were that it enrolled quite heterogeneous patients with a wide range of ages and included traumatized patients with an exactly known time of injury and severe IAS patients in whom the timing of onset of severe disease was inexactly known. [...]the COOL trial will focus on a less heterogeneous group of patients with intra-operatively confirmed SIAS in order to increase the signal to noise ratio.
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