Detail Article

Informations générales (source: ClinicalTrials.gov)

Numéro NCT

NCT04494074 En recrutement IDF

Titre

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

Type

Interventional

Pathologie

Choc septique

Phase

N/A

Promoteur

Centre Hospitalier Intercommunal Creteil (Voir sur ClinicalTrials)

Date de début

octobre 2022

Date de fin

décembre 2026

Dernière mise à jour

11 décembre 2024

Résumé

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.

Détail

Voir le détail 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 fluid resuscitation has an extremely high mortality rate. Fever is a frequent disease process during sepsis. Fever increases oxygen consumption and can worsen imbalance between oxygen supply and oxygen requirements. Fever increases inflammation but reduces viral and bacterial growth. The beneficial effects of active fever control on inflammation have been mainly shown in a context of lung injury. Pneumonia represents the first cause of septic shock in developed countries. In a pilot study (SEPSISCOOL I), we showed that fever treatment using external cooling significantly increased the resolution of shock, improved organ functions and decreased d-14 mortality. Although reduced, hospital mortality was not significantly different. This study was underpowered to allow conclusion on mortality. A more pronounced beneficial effect was observed among the most severely ill patients with elevated serum lactate level. Fever treatment is commonly applied in septic patients but its impact on survival remains undetermined. The main objective of the study is to compare two strategies of fever management in febrile (body temperature > 38.3°C) septic shock patients requiring invasive mechanical ventilation and sedation. These patients will be randomly allocated in two arms: 1. Fever respect 2. Fever control by external cooling to obtain normothermia during 48 hours A covariate-adaptive randomization will be used to ensure the comparability of the two groups at each stage of the study. We will use an adaptive multistage population-enrichment design with a pre-specified subgroup of patients with ARDS identified at randomization. An independent Safety and Data Monitoring Committee will review data on serious adverse events. The decision of study stop for potential harmful effect of one strategy will be let at the entire responsibility of the committee. One interim analysis will be performed by independent observers after enrolment of half of the population. The assumption that fever treatment is more effective in patients with ARDS will be confirmed or not. According to pre-defined rules based on the conditional power calculated in the two subgroups, the trial will be stopped for futility, continued as planned or continued by enrolling only patients with ARDS. Fermer le détail

Etablissements

Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données
CHI DE CRETEIL	Frédérique Schortgen	En recrutement IDF	29/03/2024 01:30:04	Contacter
HOPITAL FOCH	JEROME DEVAQUET	En recrutement IDF	07/04/2025 07:02:20	Contacter
Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
CH DE VERSAILLES SITE ANDRE MIGNOT	LEGRIEL Stéphane, MD	En recrutement IDF		Contact (sur clinicalTrials)
GRAND HOPITAL DE L'EST FRANCILIEN	Ly Van Phach VONG, MD	En recrutement IDF		Contact (sur clinicalTrials)
Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
Centre hospitalier intercommunal de Créteil - Créteil - France	SCHORTGEN Frédérique, MD	En recrutement		Contact (sur clinicalTrials)
CH BIGORRE SITE GESPE Tarbes - Tarbes - France	Philippe PETUA, MD	En recrutement		Contact (sur clinicalTrials)
CH Cholet - Cholet - France	Julien DUPEYRAT, MD	En recrutement		Contact (sur clinicalTrials)
CH Lens - 62300 - Lens - France	Camille POUTREAU, MD	Recrutement non commencé		Contact (sur clinicalTrials)
CH Libourne - Libourne - France	Caroline JANNIERE NARTEY, MD	En recrutement		Contact (sur clinicalTrials)
CH Victor Dupouy - Argenteuil - France	Gaetan PLANTEFEVE, MD	En recrutement		Contact (sur clinicalTrials)
CHBA Vannes-Auray - Vannes - France	Agathe Delbove, MD	En recrutement		Contact (sur clinicalTrials)
CHD Dijon - Dijon - France	QUENOT Jean Pierre, MD	En recrutement		Contact (sur clinicalTrials)
CHD Vendée - La Roche sur Yon - France	TOUSSAINT Aurélie, MD	En recrutement		Contact (sur clinicalTrials)
CHR Metz Hôpital de Mercy - Metz - France	Guillaume LOUIS, MD	Recrutement non commencé		Contact (sur clinicalTrials)
CHU Amiens - Amiens - France	Julien MAIZEL, MD	En recrutement		Contact (sur clinicalTrials)
CHU Angers - Angers - France	ASFAR Pierre, MD	En recrutement		Contact (sur clinicalTrials)
CHU Archet 1 - Nice - France		Active, sans recrutement		Contact (sur clinicalTrials)
CHU Charles Nicolle - Rouen - France	Dorothée CARPENTIER, MD	En recrutement		Contact (sur clinicalTrials)
CHU Grenoble - Grenoble - France	Guillaume DUMAS, MD	En recrutement		Contact (sur clinicalTrials)
CHU Hotel Dieu - Nantes - France	LASCARROU Jean Baptiste, MD	En recrutement		Contact (sur clinicalTrials)
CHU Kremlin Bicetre - Le Kremlin-Bicêtre - France		Active, sans recrutement		Contact (sur clinicalTrials)
CHU La Milétrie Poitiers - Poitiers - France	Remi COUDROY, MD	En recrutement		Contact (sur clinicalTrials)
CHU Le Mans - Le Mans - France	Christophe GUITTON, MD	En recrutement		Contact (sur clinicalTrials)
CHU Reims - Reims - France		Active, sans recrutement		Contact (sur clinicalTrials)
CHU Réunion Sud - Saint-Denis - France	Simon OLIVIER, MD	En recrutement		Contact (sur clinicalTrials)
GRH Mulhouse - Mulhouse - France	Anne Florence DUREAU	En recrutement		Contact (sur clinicalTrials)
Hôpital de la Croix-Rousse - Lyon - France	Jean Christophe RICHARD, MD	En recrutement		Contact (sur clinicalTrials)
Hôpital FOCH - Suresnes - France	Jérome DEVAQUET, MD	En recrutement		Contact (sur clinicalTrials)
Hôpital Henri Mondor - Créteil - France		Active, sans recrutement		Contact (sur clinicalTrials)
Hopital Lariboisière - Réanimation Médicale - Paris - France	DEYE Nicolas, MD	En recrutement		Contact (sur clinicalTrials)
Hôpital Lariboisière -Réanimation chirurgicale - Paris - France	CHOUSTERMAN Benjamin, MD	En recrutement		Contact (sur clinicalTrials)
Hôpital Nord Franche Comté - Belfort - France	Julio BADIE, MD	En recrutement		Contact (sur clinicalTrials)
Hôpital Pasteur - Nice - France	Alexandre ROBERT, MD	En recrutement		Contact (sur clinicalTrials)
Hôpital Saint Joseph Saint Luc - 69001 - Lyon - France	Emmanuel VIVIER, MD	Recrutement non commencé		Contact (sur clinicalTrials)
Hôpital Timone - Marseille - France		Active, sans recrutement		Contact (sur clinicalTrials)

Critères

Genre

Tous

Nombre d'inclusion

Critère d'inclusion

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

Critère de non inclusion

- 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

NCT04494074 - Intérêt du Traitement de la fièvre Par Refroidissement Externe Pour la Survie Des Patients ventilés en Choc Septique

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Etablissements
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