Septic Shock Clinical Trial
Official title:
Impact of External Cooling in Septic Shock Patients
The rapidity of the resolution of cardiovascular failure has a strong impact on septic shock patients' outcome. The aim of this multicenter randomized controlled trial is to determine whether external cooling might accelerate improvement in cardiovascular function.
Patients suffering from septic shock need fluid resuscitation and vasopressor therapy for
restoring cardiovascular function. Corticosteroids and activated protein C have been both
proposed for vascular tone improvement. While external cooling is largely used in ICU
febrile patients, benefits and risks of fever treatment during sepsis have been rarely
studied. Surveys show that external cooling is usual care applied by nurses themselves
without medical order.
The control of thermal balance might decrease cardiac output and oxygen consumption, and
reduce serum lactate concentration. However some animal studies have suggested that fever
might be essential for host defence. This trial compares two strategies of fever management
on vasopressor dependence in septic shock patients. In the treatment group, external cooling
is applied to normalize the body temperature between 36°5 C and 37°C, while control patients
receive any fever treatment. The goal for mean arterial pressure is the same in the two
groups and vasopressor withdrawal is determined by similar algorithm.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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