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

Status: Recruiting
Location: See all (33) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
CHU Amiens
RECRUITING
Amiens
CHU Angers
RECRUITING
Angers
CH Victor Dupouy
RECRUITING
Argenteuil
Hôpital Nord Franche Comté
RECRUITING
Belfort
CH Cholet
RECRUITING
Cholet
Centre hospitalier intercommunal de Créteil
RECRUITING
Créteil
Hôpital Henri Mondor
ACTIVE_NOT_RECRUITING
Créteil
CHD Dijon
RECRUITING
Dijon
CHU Grenoble
RECRUITING
Grenoble
GH Est Francilien
RECRUITING
Jossigny
CHD Vendée
RECRUITING
La Roche-sur-yon
CHU Kremlin Bicetre
ACTIVE_NOT_RECRUITING
Le Kremlin-bicêtre
CHU Le Mans
RECRUITING
Le Mans
CH Lens
NOT_YET_RECRUITING
Lens
CH Libourne
RECRUITING
Libourne
Hôpital de la Croix-Rousse
RECRUITING
Lyon
Hôpital Saint Joseph Saint Luc
NOT_YET_RECRUITING
Lyon
Hôpital Timone
ACTIVE_NOT_RECRUITING
Marseille
CHR Metz Hôpital de Mercy
NOT_YET_RECRUITING
Metz
GRH Mulhouse
RECRUITING
Mulhouse
CHU Hotel Dieu
RECRUITING
Nantes
CHU Archet 1
ACTIVE_NOT_RECRUITING
Nice
Hôpital Pasteur
RECRUITING
Nice
Hopital Lariboisière - Réanimation Médicale
RECRUITING
Paris
Hôpital Lariboisière -Réanimation chirurgicale
RECRUITING
Paris
CHU La Milétrie Poitiers
RECRUITING
Poitiers
CHU Reims
ACTIVE_NOT_RECRUITING
Reims
CHU Charles Nicolle
RECRUITING
Rouen
CHU Réunion Sud
RECRUITING
Saint-denis
Hôpital FOCH
RECRUITING
Suresnes
CH BIGORRE SITE GESPE Tarbes
RECRUITING
Tarbes
CHBA Vannes-Auray
RECRUITING
Vannes
Centre Hospitalier Mignot
RECRUITING
Versailles
Contact Information
Primary
Frédérique SCHORTGEN, MD
Frederique.schortgen@chicreteil.fr
01 57 02 34 11
Backup
Camille JUNG, MD
camille.jung@chicreteil.fr
01 57 02 22 68
Time Frame
Start Date: 2022-10-01
Estimated Completion Date: 2026-12-01
Participants
Target number of participants: 820
Treatments
Experimental: Fever Control by external cooling
External cooling during 48 hours to obtain normothermia
No_intervention: Fever respected, no cooling
Fever respect without any antipyretic therapy
Related Therapeutic Areas
Sponsors
Leads: Centre Hospitalier Intercommunal Creteil

This content was sourced from clinicaltrials.gov