External Cooling in Septic Shock Patients (sepsis-cool)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Impact of External Cooling in Septic Shock Patients|
- Number of patients with a decrease in the dose of vasopressors of 50% 48 hours after enrolment [ Time Frame: 48 hours after enrolment ] [ Designated as safety issue: Yes ]
- Maximal dose of vasopressors [ Time Frame: within 48 hours after enrolment ] [ Designated as safety issue: Yes ]
- SOFA score evolution [ Time Frame: on Day 3, Day 7, Day 14 ] [ Designated as safety issue: No ]
- Number of vasopressor free days in the ICU [ Time Frame: during the study ] [ Designated as safety issue: Yes ]
|Study Start Date:||October 2007|
|Study Completion Date:||March 2010|
|Primary Completion Date:||March 2010 (Final data collection date for primary outcome measure)|
Other: External cooling
Other Name: external cooling
|No Intervention: B|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00527007
|CHU Henri Mondor|
|Creteil, France, 94000|
|Principal Investigator:||Frederique SCHORTGEN, MD||Assistance Publique - Hôpitaux de Paris|