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Fever Control Using External Cooling in Mechanically Ventilated Patients With Septic Shock

NCT ID: NCT04494074

Last Updated: 2024-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

820 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-01

Study Completion Date

2026-12-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Septic Shock

Keywords

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External cooling, Fever ARDS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Fever Control by external cooling

External cooling during 48 hours to obtain normothermia

Group Type EXPERIMENTAL

External Cooling

Intervention Type OTHER

External Cooling

Fever respected, no cooling

Fever respect without any antipyretic therapy

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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External Cooling

External Cooling

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Intercommunal Creteil

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Amiens

Amiens, , France

Site Status RECRUITING

CHU Angers

Angers, , France

Site Status RECRUITING

CH Victor Dupouy

Argenteuil, , France

Site Status RECRUITING

Hôpital Nord Franche Comté

Belfort, , France

Site Status RECRUITING

CH Cholet

Cholet, , France

Site Status RECRUITING

Centre hospitalier intercommunal de Créteil

Créteil, , France

Site Status RECRUITING

Hôpital Henri Mondor

Créteil, , France

Site Status ACTIVE_NOT_RECRUITING

CHD Dijon

Dijon, , France

Site Status RECRUITING

CHU Grenoble

Grenoble, , France

Site Status RECRUITING

GH Est Francilien

Jossigny, , France

Site Status RECRUITING

CHD Vendée

La Roche-sur-Yon, , France

Site Status RECRUITING

CHU Kremlin Bicetre

Le Kremlin-Bicêtre, , France

Site Status ACTIVE_NOT_RECRUITING

CHU Le Mans

Le Mans, , France

Site Status RECRUITING

CH Lens

Lens, , France

Site Status NOT_YET_RECRUITING

CH Libourne

Libourne, , France

Site Status RECRUITING

Hôpital Saint Joseph Saint Luc

Lyon, , France

Site Status NOT_YET_RECRUITING

Hôpital de la Croix-Rousse

Lyon, , France

Site Status RECRUITING

Hôpital Timone

Marseille, , France

Site Status ACTIVE_NOT_RECRUITING

CHR Metz Hôpital de Mercy

Metz, , France

Site Status NOT_YET_RECRUITING

GRH Mulhouse

Mulhouse, , France

Site Status RECRUITING

CHU Hotel Dieu

Nantes, , France

Site Status RECRUITING

CHU Archet 1

Nice, , France

Site Status ACTIVE_NOT_RECRUITING

Hôpital Pasteur

Nice, , France

Site Status RECRUITING

Hopital Lariboisière - Réanimation Médicale

Paris, , France

Site Status RECRUITING

Hôpital Lariboisière -Réanimation chirurgicale

Paris, , France

Site Status RECRUITING

CHU La Milétrie Poitiers

Poitiers, , France

Site Status RECRUITING

CHU Reims

Reims, , France

Site Status ACTIVE_NOT_RECRUITING

CHU Charles Nicolle

Rouen, , France

Site Status RECRUITING

CHU Réunion Sud

Saint-Denis, , France

Site Status RECRUITING

Hôpital FOCH

Suresnes, , France

Site Status RECRUITING

CH BIGORRE SITE GESPE Tarbes

Tarbes, , France

Site Status RECRUITING

CHBA Vannes-Auray

Vannes, , France

Site Status RECRUITING

Centre Hospitalier Mignot

Versailles, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Frédérique SCHORTGEN, MD

Role: CONTACT

Phone: 01 57 02 34 11

Email: [email protected]

Camille JUNG, MD

Role: CONTACT

Phone: 01 57 02 22 68

Email: [email protected]

Facility Contacts

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Julien MAIZEL, MD

Role: primary

ASFAR Pierre, MD

Role: primary

Gaetan PLANTEFEVE, MD

Role: primary

Julio BADIE, MD

Role: primary

Julien DUPEYRAT, MD

Role: primary

SCHORTGEN Frédérique, MD

Role: primary

QUENOT Jean Pierre, MD

Role: primary

Guillaume DUMAS, MD

Role: primary

Ly Van Phach VONG, MD

Role: primary

TOUSSAINT Aurélie, MD

Role: primary

Christophe GUITTON, MD

Role: primary

Camille POUTREAU, MD

Role: primary

Caroline JANNIERE NARTEY, MD

Role: primary

Emmanuel VIVIER, MD

Role: primary

Jean Christophe RICHARD, MD

Role: primary

Guillaume LOUIS, MD

Role: primary

Anne Florence DUREAU

Role: primary

LASCARROU Jean Baptiste, MD

Role: primary

Alexandre ROBERT, MD

Role: primary

DEYE Nicolas, MD

Role: primary

CHOUSTERMAN Benjamin, MD

Role: primary

Remi COUDROY, MD

Role: primary

Dorothée CARPENTIER, MD

Role: primary

Simon OLIVIER, MD

Role: primary

Jérome DEVAQUET, MD

Role: primary

Philippe PETUA, MD

Role: primary

Agathe Delbove, MD

Role: primary

LEGRIEL Stéphane, MD

Role: primary

References

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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.

Reference Type DERIVED
PMID: 38286691 (View on PubMed)

Other Identifiers

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SEPSISCOOL II

Identifier Type: -

Identifier Source: org_study_id