Controlling fever in patients with septic shock using external cooling

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to compare two strategies for managing fever in mechanically ventilated patients suffering from septic shock. Participants will be randomly assigned to either continue with their fever or to receive external cooling to maintain normothermia. The study seeks to determine which approach leads to better outcomes, particularly focusing on mortality rates at 60 days. The trial builds on previous findings that suggest fever control may improve organ function and reduce mortality in severely ill patients.

Why it matters

Who can join: the full rules

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

Where it's running

• CHU Amiens
  Amiens, France Recruiting
• CHU Angers
  Angers, France Recruiting
• CH Victor Dupouy
  Argenteuil, France Recruiting
• Hôpital Nord Franche Comté
  Belfort, France Recruiting
• CH Cholet
  Cholet, France Recruiting
• Centre hospitalier intercommunal de Créteil
  Créteil, France Recruiting

Study contacts

• Study coordinator: Frédérique SCHORTGEN, MD
• Email: Frederique.schortgen@chicreteil.fr
• Phone: 01 57 02 34 11

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Adjunctive Fludrocortisone in Septic Shock on Hydrocortisone

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• Non-invasive hemodynamic guidance for sepsis care on medical wards

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• Reducing Endotoxin Burden in Septic Shock Patients on CRRT with the oXiris Filter

  This trial tests whether using the oXiris hemofilter during continuous kidney replacement helps lower endotoxin levels in adults with septic shock who need CRRT.

  Recruiting Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Guangzhou, Guangdong · NCT07807410

• Personalized Fluid Resuscitation in the Emergency Department

  This pilot test checks if a quick, non-invasive stroke-volume assessment can help ED doctors tailor IV fluids for septic patients with low blood pressure.

  Recruiting Intermountain Health Care, Inc. · Murray, Utah · NCT07779720

• Discordance between capillary refill time and oxygen use in septic shock

  This study tests whether some septic shock patients can have a normal capillary refill time but still lack tissue oxygen use, to see if that mismatch relates to 28-day survival.

  Recruiting Istanbul University - Cerrahpasa · Istanbul · NCT07774962

• Targeting upper-normal magnesium to see if norepinephrine needs drop in septic shock

  This trial tests whether keeping magnesium levels at the upper end of normal can reduce the amount and duration of norepinephrine needed in adults with septic shock.

  Recruiting Alexandria University · Alexandria, Alexandria Governorate · NCT07716956

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.