Status:
RECRUITING
Fever Control Using External Cooling in Mechanically Ventilated Patients With Septic Shock
Lead Sponsor:
Centre Hospitalier Intercommunal Creteil
Conditions:
Septic Shock
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 ...
Detailed Description
Sepsis is a common syndrome responsible for multiple organ failure. Septic shock, defined as sepsis with hyperlactatemia and cardiovascular failure requiring vasopressor infusion despite adequate flui...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
820 Patients enrolled
Trial Details
Trial ID
NCT04494074
Start Date
October 1 2022
End Date
December 1 2026
Last Update
December 10 2024
Active Locations (33)
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1
CHU Amiens
Amiens, France
2
CHU Angers
Angers, France
3
CH Victor Dupouy
Argenteuil, France
4
Hôpital Nord Franche Comté
Belfort, France