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NCT04494074
Fever Control Using External Cooling in Mechanically Ventilated Patients With Septic Shock
Conditions: Septic Shock
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 820
Sponsor: Centre Hospitalier Intercommunal Creteil
Location: CHU Amiens Amiens
Summary
The best strategy for managing fever in patients with septic shock remains unknown. In a pilot study, the investigators showed that fever control at normothermia allowed a better control of shock and evolution of organ failures. In this second trial the investigators will conduct a multicentre, open-label, randomized controlled, superiority trial in which two strategies will be compared:
1. Respect of fever
2. Fever control at normothermia using external cooling The primary end point will be d-60 mortality.
Eligibility Criteria
Inclusion Criteria:
* Documented or suspected infection either communautary or hospital acquired
* Septic shock defined by the need for vasopressor and lactate\>2 mmol/l despite adequate fluid resuscitation (sepsis-3 definition)
* Patients under invasive mechanical ventilation
* Body core temperature\>38.3°C
* Intravenous sedation or opioids
* Ongoing antimicrobial treatment and/or intervention for infection source control
* Attending physician confirms clinical equipoise without substantial risk if the patient participates in the trial
* Informed consent of next of kin/other designated person before inclusion or procedure for inclusion in emergency situation
Exclusion Criteria:
* Cardiac arrest within previous 7 days
* Acute brain injury within previous 7 days
* Extensive burns or epidermal necrolysis
* \41°C
* Under legal guardianship
* No affiliation with the French health-care system
* Pregnancy
* Participation in another interventional study with mortality as the primary endpoint
* An investigator's decision not to resuscitate
* Patient already recruited in the trial
Source: ClinicalTrials.gov (NCT04494074). StuddyBuddy aggregates publicly available trial information.