CHU Henri Mondor
Créteil, 94000, France
NCT Number: NCT00527007
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Créteil, 94000, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
External cooling
Time frame: 48 hours after enrolment
Time frame: within 48 hours after enrolment
Time frame: on Day 3, Day 7, Day 14
Time frame: during the study
Assistance Publique - Hôpitaux de Paris
Other
Impact of External Cooling in Septic Shock Patients
Acronym: sepsis-cool
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