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Controlling fever in patients with septic shock using external cooling

Intérêt du Traitement de la fièvre Par Refroidissement Externe Pour la Survie Des Patients ventilés en Choc Septique

Not applicable Interventional Centre Hospitalier Intercommunal Creteil · NCT04494074

This study tests whether using external cooling to control fever helps people on ventilators with septic shock live longer and feel better compared to letting their fever continue.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment820 (estimated)
Ages18 Years and up
SexAll
SponsorCentre Hospitalier Intercommunal Creteil Academic / other
Locations33 sites (Amiens and 32 other locations)
Trial IDNCT04494074 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to compare two strategies for managing fever in mechanically ventilated patients suffering from septic shock. Participants will be randomly assigned to either continue with their fever or to receive external cooling to maintain normothermia. The study seeks to determine which approach leads to better outcomes, particularly focusing on mortality rates at 60 days. The trial builds on previous findings that suggest fever control may improve organ function and reduce mortality in severely ill patients.

Who should consider this trial

Good fit: Ideal candidates are adults with documented or suspected infections leading to septic shock, requiring mechanical ventilation and exhibiting fever.

Not a fit: Patients with recent cardiac arrest, acute brain injury, or those under 18 years old will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve survival rates and organ function in patients with septic shock.

How similar studies have performed: Previous studies have shown promising results with fever control in similar patient populations, indicating potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion 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
* \<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

Where this trial is running

Amiens and 32 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Septic ShockExternal cooling,FeverARDS
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.