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Fever Control Using External Cooling in Mechanically Ventilated Patients With Septic Shock

Sponsor: Centre Hospitalier Intercommunal Creteil • ClinicalTrials.gov ID: NCT04494074

Registry updated: 2026-09-21

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Description

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.

Interventions

External Cooling (Other)
External Cooling

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 * \<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

Conditions

Septic Shock

Locations

CHU Amiens — Amiens, France
CHU Angers — Angers, France
CH Victor Dupouy — Argenteuil, France
Hôpital Nord Franche Comté — Belfort, France
CH Cholet — Cholet, France
Centre hospitalier intercommunal de Créteil — Créteil, France
Hôpital Henri Mondor — Créteil, France
CHD Dijon — Dijon, France
CHU Grenoble — Grenoble, France
GH Est Francilien — Jossigny, France
CHD Vendée — La Roche-sur-Yon, France
CHU Kremlin Bicetre — Le Kremlin-Bicêtre, France
CHU Le Mans — Le Mans, France
CH Lens — Lens, France
CH Libourne — Libourne, France
Hôpital Saint Joseph Saint Luc — Lyon, France
Hôpital de la Croix-Rousse — Lyon, France
Hôpital Timone — Marseille, France
CHR Metz Hôpital de Mercy — Metz, France
GRH Mulhouse — Mulhouse, France
CHU Hotel Dieu — Nantes, France
CHU Archet 1 — Nice, France
Hôpital Pasteur — Nice, France
Hopital Lariboisière - Réanimation Médicale — Paris, France
Hôpital Lariboisière -Réanimation chirurgicale — Paris, France
CHU La Milétrie Poitiers — Poitiers, France
CHU Reims — Reims, France
CHU Charles Nicolle — Rouen, France
CHU Réunion Sud — Saint-Denis, France
Hôpital FOCH — Suresnes, France
CH BIGORRE SITE GESPE Tarbes — Tarbes, France
CHBA Vannes-Auray — Vannes, France
Centre Hospitalier Mignot — Versailles, France

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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