Fever Control Using External Cooling in Mechanically Ventilated Patients With Septic Shock
Intérêt du Traitement de la fièvre Par Refroidissement Externe Pour la Survie Des Patients ventilés en Choc Septique
Centre Hospitalier Intercommunal Creteil
820 participants
Oct 1, 2022
INTERVENTIONAL
Conditions
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
Inclusion Criteria8
- 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 Criteria11
- Cardiac arrest within previous 7 days
- Acute brain injury within previous 7 days
- Extensive burns or epidermal necrolysis
- <18 years old
- Body core temperature >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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Interventions
External Cooling
Locations(33)
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NCT04494074