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Recruiting 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

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT04494074). StuddyBuddy aggregates publicly available trial information.