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NCT04494074

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

Recruiting now NA Last updated 10 December 2024
What this trial tests

NA trial testing External Cooling in Septic Shock in 820 participants. Currently enrolling.

Timeline
1 October 2022
Primary endpoint
1 December 2026
1 December 2026

Quick facts

Lead sponsorCentre Hospitalier Intercommunal Creteil
PhaseNA
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposetreatment
Enrollment820
Start date1 October 2022
Primary completion1 December 2026
Estimated completion1 December 2026
Sites33 locations across France

Drugs / interventions tested

Conditions studied

Sponsor

Centre Hospitalier Intercommunal Creteil

Who can join

18 and older, any sex, with Septic Shock. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Management of spontaneous septic hypothermia in intensive care. A national survey of French intensive care units.
    Eustache G, Le Balc'h P, Launey Y. · · 2024 · PMID 38903822 · DOI 10.3389/fmed.2024.1393781
  2. Protocol for fever control using external cooling in mechanically ventilated patients with septic shock: SEPSISCOOL II randomised controlled trial.
    Guénégou-Arnoux A, Murris J, Bechet S, Jung C, et al · · 2024 · PMID 38286691 · DOI 10.1136/bmjopen-2022-069430

Verify or expand the search:

Other recruiting trials for Septic Shock

Currently open trials in the same condition.

Other Centre Hospitalier Intercommunal Creteil trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04494074.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing