Spontaneous Hypothermia And Rewarming In Sepsis (SHARIS)

Abstract

Spontaneous hypothermia in septic patients is frequently fought off with active rewarming, but this practice is not evidence-based. Moreover, the need for rewarming patients from hypothermia in this case has been recently questioned by a study showing that septic hypothermia is a transient, self-limiting and non-terminal response. Here, we propose a prospective, interventional trial to assess whether it is unnecessary to use active rewarming to counter spontaneous hypothermia during sepsis. Septic patients that present core temperature of 35.9ºC or less will be enrolled in the study. They will be randomized into two groups: one group will be subjected to active rewarming as soon as hypothermia is detected; the other group will have hypothermia run its natural course (within a safe margin). The primary outcome will be the evolution of SOFA scores over time. As secondary outcomes, we will evaluate thermal comfort and the levels of C-reactive protein and lactate, as well as the incidence of respiratory distress, shock, renal dysfunction, hepatic dysfunction, coagulopathy and cerebral dysfunction. Mortality rate, length of ICU stay and ICU-free days to day 28 will also be assessed. The study does not add risk to the current management of septic hypothermia, since both rewarming and no rewarming are currently used in an arbitrary fashion. The present study is expected to pave the road to an evidence-based guideline for the management of septic hypothermia. (AU)