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Chilling fever: can cooling septic shock patients save lives?

NCT ID NCT04494074

NEW Symptom relief Sponsor: Centre Hospitalier Intercommunal Creteil Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 21, 2026 · Last updated Sep 21, 2026

Summary

Researchers are testing two ways to manage fever in patients with septic shock who are on breathing machines. One group receives standard care that allows fever to continue, while the other group receives external cooling to bring body temperature down to normal. The trial compares death rates at 60 days and changes in organ failure scores to see which approach works better.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
external cooling to lower body temperature
What this could lead to
If cooling fever helps, it could become a simple, widely available way to improve survival for patients with septic shock on ventilators.
What could go wrong
Fever may help the body fight infection, so cooling it could be harmful. This is an open-label trial, and results may not apply to all septic shock patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 820 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2022

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Fever toxic shock syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Septic shock

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    28 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • CH BIGORRE SITE GESPE Tarbes

    RECRUITING

    Tarbes, France

  • CH Cholet

    RECRUITING

    Cholet, France

  • CH Lens

    NOT_YET_RECRUITING

    Lens, 62300, France

  • CH Libourne

    RECRUITING

    Libourne, France

  • CH Victor Dupouy

    RECRUITING

    Argenteuil, France

  • CHBA Vannes-Auray

    RECRUITING

    Vannes, France

  • CHD Dijon

    RECRUITING

    Dijon, France

  • CHD Vendée

    RECRUITING

    La Roche-sur-Yon, France

  • CHR Metz Hôpital de Mercy

    NOT_YET_RECRUITING

    Metz, France

  • CHU Amiens

    RECRUITING

    Amiens, France

  • CHU Angers

    RECRUITING

    Angers, France

  • CHU Archet 1

    ACTIVE_NOT_RECRUITING

    Nice, France

  • CHU Charles Nicolle

    RECRUITING

    Rouen, France

  • CHU Grenoble

    RECRUITING

    Grenoble, France

  • CHU Hotel Dieu

    RECRUITING

    Nantes, France

  • CHU Kremlin Bicetre

    ACTIVE_NOT_RECRUITING

    Le Kremlin-Bicêtre, France

  • CHU La Milétrie Poitiers

    RECRUITING

    Poitiers, France

  • CHU Le Mans

    RECRUITING

    Le Mans, France

  • CHU Reims

    ACTIVE_NOT_RECRUITING

    Reims, France

  • CHU Réunion Sud

    RECRUITING

    Saint-Denis, France

  • Centre Hospitalier Mignot

    RECRUITING

    Versailles, France

  • Centre hospitalier intercommunal de Créteil

    RECRUITING

    Créteil, France

  • GH Est Francilien

    RECRUITING

    Jossigny, France

  • GRH Mulhouse

    RECRUITING

    Mulhouse, France

  • Hopital Lariboisière - Réanimation Médicale

    RECRUITING

    Paris, France

  • Hôpital FOCH

    RECRUITING

    Suresnes, France

  • Hôpital Henri Mondor

    ACTIVE_NOT_RECRUITING

    Créteil, France

  • Hôpital Lariboisière -Réanimation chirurgicale

    RECRUITING

    Paris, France

  • Hôpital Nord Franche Comté

    RECRUITING

    Belfort, France

  • Hôpital Pasteur

    RECRUITING

    Nice, France

  • Hôpital Saint Joseph Saint Luc

    NOT_YET_RECRUITING

    Lyon, 69001, France

  • Hôpital Timone

    ACTIVE_NOT_RECRUITING

    Marseille, France

  • Hôpital de la Croix-Rousse

    RECRUITING

    Lyon, France

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