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

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 2 years later Dec 1, 2026 → Dec 1, 2028
See other at-risk trials from Centre Hospitalier Intercommunal Creteil

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary and study completion pushed from Dec 1, 2026 to Dec 1, 2028 Show 4 more changesShow less
    • Eligibility criteria expanded, about 12 words
    • Secondary endpoints: details revised at 3 of 12 entries
    • Publications: details revised at 1 of 1 entry
    • Study description expanded, about 2 words
  2. Site details revised at 2 of 33 sitesv20
  3. Site details revised at 1 of 33 sitesv19
  4. Primary and study completion dates: Dec 1, 2024 to Dec 1, 2026
    • Study sites: 29 to 33
    v18
  5. Primary completion date: Dec 1, 2022 to Dec 1, 2024
    • Study sites: 9 to 29
    • Eligibility criteria expanded, about 26 words
    • Secondary endpoints revised (12)
    v17
Show 15 earlier versionsHide 15 earlier versions
  1. Eligibility criteria expanded, about 6 words
    • Site details revised at 1 of 9 sites
    v16
  2. Site details revised at 1 of 9 sitesv15
  3. Site details revised at 1 of 9 sitesv14
  4. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 9
    v13
  5. Primary completion date: Aug 1, 2024 to Dec 1, 2022
    • Start date: Jun 1, 2022 to Oct 1, 2022
    • Study completion date: Oct 1, 2024 to Dec 1, 2024
    v12
  6. Primary completion date: Mar 1, 2022 to Aug 1, 2024
    • Start date: Jan 1, 2022 to Jun 1, 2022
    • Study completion date: Mar 1, 2024 to Oct 1, 2024
    v11
  7. Primary completion date: Dec 1, 2023 to Mar 1, 2022
    • Start date: Oct 1, 2021 to Jan 1, 2022
    • Study completion date: Dec 1, 2023 to Mar 1, 2024
    v10
  8. Start date: May 1, 2021 to Oct 1, 2021
    • Primary and study completion dates: Jul 1, 2023 to Dec 1, 2023
    v9
  9. Primary completion date: Feb 1, 2022 to Jul 1, 2023
    • Start date: Feb 1, 2021 to May 1, 2021
    • Study completion date: Apr 1, 2023 to Jul 1, 2023
    v8
  10. Secondary endpoints: details revised at 3 of 12 entriesv7
  11. Start date: Dec 1, 2020 to Feb 1, 2021
    • Primary completion date: Dec 1, 2022 to Feb 1, 2022
    • Study completion date: Feb 1, 2023 to Apr 1, 2023
    v6
  12. 2 versions Re-verified since Aug 31, 2020, no change to tracked fieldsv4-v5
  13. Secondary endpoints: details revised at 1 of 12 entriesv3
  14. Secondary endpoints: details revised at 4 of 12 entriesv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Details
NCT Number NCT04494074
Lead Sponsor Centre Hospitalier Intercommunal Creteil
Conditions
(from sponsor)		 Septic Shock
Related terms Fever, Shock, Septic
Enrollment 820 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov