Fever Control Using External Cooling in Mechanically Ventilated Patients With Septic Shock
Intérêt du Traitement de la fièvre Par Refroidissement Externe Pour la Survie Des Patients ventilés en Choc Septique
1 other identifier
interventional
820
1 country
33
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2022
Longer than P75 for not_applicable
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 28, 2020
CompletedFirst Posted
Study publicly available on registry
July 31, 2020
CompletedStudy Start
First participant enrolled
October 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
December 10, 2024
December 1, 2024
4.2 years
July 28, 2020
December 9, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mortality
All causes mortality
Day 60 from randomization
Secondary Outcomes (12)
Evolution of SOFA Score
Up to Day 7
Number of ventilator free days
Day 28
Number of renal replacement therapy free days
Day 28
Number of vasopressor free days
Day 28
Mortality
Day 28
- +7 more secondary outcomes
Study Arms (2)
Fever Control by external cooling
EXPERIMENTALExternal cooling during 48 hours to obtain normothermia
Fever respected, no cooling
NO INTERVENTIONFever respect without any antipyretic therapy
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (33)
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, 62300, France
CH Libourne
Libourne, France
Hôpital Saint Joseph Saint Luc
Lyon, 69001, 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
Related Publications (1)
Guenegou-Arnoux A, Murris J, Bechet S, Jung C, Auchabie J, Dupeyrat J, Anguel N, Asfar P, Badie J, Carpentier D, Chousterman B, Bourenne J, Delbove A, Devaquet J, Deye N, Dumas G, Dureau AF, Lascarrou JB, Legriel S, Guitton C, Janniere-Nartey C, Quenot JP, Lacherade JC, Maizel J, Mekontso Dessap A, Mourvillier B, Petua P, Plantefeve G, Richard JC, Robert A, Saccheri C, Vong LVP, Katsahian S, Schortgen F; REVA Network. Protocol for fever control using external cooling in mechanically ventilated patients with septic shock: SEPSISCOOL II randomised controlled trial. BMJ Open. 2024 Jan 29;14(1):e069430. doi: 10.1136/bmjopen-2022-069430.
PMID: 38286691DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 28, 2020
First Posted
July 31, 2020
Study Start
October 1, 2022
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
December 10, 2024
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF, ANALYTIC CODE
- Time Frame
- After publication upon justified request from the coordinating investigator and the study sponsor
Strictly anonymized data will be available upon justified request from the coordinating investigator and the study sponsor