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Comparison of Landiolol Versus Standard of Care for Prevention of Mortality in Patients Hospitalized for a Septic Shock With Hypercontractility

Study acronym: HyperBetashock
StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Site contact updated
    • Collaborators: 27 to 28
    v6
  2. Primary completion date: Jun 2025 to Jun 2027
    • Study completion date: Mar 2026 to Sep 2027
    v5
  3. Phase: Not applicable to Phase 3
    • Primary completion date: Feb 2024 to Jun 2025
    • Study completion date: Mar 2024 to Mar 2026
    v4
  4. Primary completion date: Feb 2023 to Feb 2024
    • Study completion date: Mar 2023 to Mar 2024
    v3
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Feb 2021 to Feb 1, 2021
    • Site details revised
    v2
  6. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Several data emphasize the relation between tachycardia (\>90/min) and high mortality during septic shock. The investigators previously demonstrated the high mortality associated with hypercontractility, tachycardia and the presence of a left ventricular obstruction. A severe hypovolemia, a hyper adrenergic stimulation or a severe vasoplegia can all explain this relation between tachycardia, hypercontractility and the mortality during septic shock. Landiolol is another short-term acting beta-blocker with a half-life of 4 minutes without any beta 2 activity or membrane stabilizing effect. The landiolol has been used in critically ill patients to control supraventricular tachycardia but not in this context of tachycardia and septic shock. The investigators hypothesize that landiolol by reducing the heart rate may improve the survival of patients treated for a septic shock and presenting with an hypercontractility state.
Trial Details
NCT Number NCT04748796
Lead Sponsor Centre Hospitalier Universitaire, Amiens
Collaborators: CH Dieppe, CH Elbeuf, CH Le Havre, Centre Hospitalier de Beauvais, Centre Hospitalier Intercommunal de Compiègne-Noyon, CH Laon, University Hospital, Caen, CH Cherbourg, University Hospital, Lille, CH Douai, CH Montreuil, Centre Hospitalier de Roubaix, Centre Hospitalier de Bethune, CH Lomme, Centre Hospitalier de Lens, Tourcoing Hospital, Centre Hospitalier VALENCIENNES, Centre Hospitalier Arras, Hospital Ambroise Paré Paris, University Hospital, Brest, Henri Mondor University Hospital, Hospital Avicenne, University Hospital, Montpellier, CH Calais, Hôpital Edouard Herriot, Centre Hospitalier Universitaire de Nīmes, Groupe Hospitalier Pitie-Salpetriere, Hôpital Louis Mourier, Colombes
Conditions
(from sponsor)		 Septic Shock, Tachycardia, Mortality During Septic Shock, Beta-blocker
Related terms Shock, Septic, Tachycardia
Enrollment 360 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov