Actively Recruiting
Fever Control Using External Cooling in Mechanically Ventilated Patients With Septic Shock
Led by Centre Hospitalier Intercommunal Creteil · Updated on 2024-12-10
820
Participants Needed
33
Research Sites
217 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Fever Control Using External Cooling in Mechanically Ventilated Patients With Septic Shock
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Documented or suspected infection, either community or hospital acquired
- Septic shock defined by need for vasopressor and lactate > 2 mmol/l despite adequate fluid resuscitation
- Receiving invasive mechanical ventilation
- Body core temperature above 38.3°C
- Under intravenous sedation or opioids
- Ongoing antimicrobial treatment and/or infection source control
- Attending physician confirms clinical equipoise and no substantial risk
- Informed consent obtained from next of kin or authorized person or emergency inclusion procedure
You will not qualify if you...
- Cardiac arrest within the previous 7 days
- Acute brain injury within the previous 7 days
- Extensive burns or epidermal necrolysis
- Younger than 18 years old
- Body core temperature above 41°C
- Under legal guardianship
- No affiliation with French health-care system
- Pregnancy
- Participation in another interventional study with mortality as primary endpoint
- Investigator decision not to resuscitate
- Already recruited in this trial
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 33 locations
1
CHU Amiens
Amiens, France
Actively Recruiting
2
CHU Angers
Angers, France
Actively Recruiting
3
CH Victor Dupouy
Argenteuil, France
Actively Recruiting
4
Hôpital Nord Franche Comté
Belfort, France
Actively Recruiting
5
CH Cholet
Cholet, France
Actively Recruiting
6
Centre hospitalier intercommunal de Créteil
Créteil, France
Actively Recruiting
7
Hôpital Henri Mondor
Créteil, France
Active, Not Recruiting
8
CHD Dijon
Dijon, France
Actively Recruiting
9
CHU Grenoble
Grenoble, France
Actively Recruiting
10
GH Est Francilien
Jossigny, France
Actively Recruiting
11
CHD Vendée
La Roche-sur-Yon, France
Actively Recruiting
12
CHU Kremlin Bicetre
Le Kremlin-Bicêtre, France
Active, Not Recruiting
13
CHU Le Mans
Le Mans, France
Actively Recruiting
14
CH Lens
Lens, France, 62300
Not Yet Recruiting
15
CH Libourne
Libourne, France
Actively Recruiting
16
Hôpital Saint Joseph Saint Luc
Lyon, France, 69001
Not Yet Recruiting
17
Hôpital de la Croix-Rousse
Lyon, France
Actively Recruiting
18
Hôpital Timone
Marseille, France
Active, Not Recruiting
19
CHR Metz Hôpital de Mercy
Metz, France
Not Yet Recruiting
20
GRH Mulhouse
Mulhouse, France
Actively Recruiting
21
CHU Hotel Dieu
Nantes, France
Actively Recruiting
22
CHU Archet 1
Nice, France
Active, Not Recruiting
23
Hôpital Pasteur
Nice, France
Actively Recruiting
24
Hopital Lariboisière - Réanimation Médicale
Paris, France
Actively Recruiting
25
Hôpital Lariboisière -Réanimation chirurgicale
Paris, France
Actively Recruiting
26
CHU La Milétrie Poitiers
Poitiers, France
Actively Recruiting
27
CHU Reims
Reims, France
Active, Not Recruiting
28
CHU Charles Nicolle
Rouen, France
Actively Recruiting
29
CHU Réunion Sud
Saint-Denis, France
Actively Recruiting
30
Hôpital FOCH
Suresnes, France
Actively Recruiting
31
CH BIGORRE SITE GESPE Tarbes
Tarbes, France
Actively Recruiting
32
CHBA Vannes-Auray
Vannes, France
Actively Recruiting
33
Centre Hospitalier Mignot
Versailles, France
Actively Recruiting
Research Team
F
Frédérique SCHORTGEN, MD
CONTACT
C
Camille JUNG, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here