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Comparison of Landiolol versus standard of care for prevention of mortality in patients hospitalized for a septic shock with hypercontractlity: an open label prospective randomized study

Status
Not yet recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-518251-31-00
Acronym
PI2020_843_0057
Enrollment
360
Registered
2024-10-22
Start date
Unknown
Completion date
Unknown
Last updated
2025-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

patients hospitalized for a septic shock with hypercontractlity

Brief summary

mortality at day 28

Detailed description

- Number of patients that achieved a reduction of heart rate equal or higher to 20% of the initial HR with landiolol, - Number of days receiving catecholamines, - Number of days receiving mechanical ventilation, - Length of stay in ICU and hospital, - SOFA score at inclusion and day 1, 2, 3, 7, 14 and 28 following the inclusion, - Number of patients developing atrial fibrillation of flutter during the first three days, - Hospital mortality, - Number of episodes of bradycardia (<50 bpm) or LVEF < 45% or MAP <65mmHg requiring an increase of Norepinephrine > 40% during the entire period of treatment with the landiolol, - Unexpected cardiac arrest

Interventions

DRUGCHLORURE DE SODIUM 0
DRUGsolution pour perfusion
DRUGRapibloc 300 mg powder for solution for infusion.

Sponsors

Centre Hospitalier Universitaire Amiens Picardie
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
mortality at day 28

Secondary

MeasureTime frame
- Number of patients that achieved a reduction of heart rate equal or higher to 20% of the initial HR with landiolol, - Number of days receiving catecholamines, - Number of days receiving mechanical ventilation, - Length of stay in ICU and hospital, - SOFA score at inclusion and day 1, 2, 3, 7, 14 and 28 following the inclusion, - Number of patients developing atrial fibrillation of flutter during the first three days, - Hospital mortality, - Number of episodes of bradycardia (<50 bpm) or LVEF < 45% or MAP <65mmHg requiring an increase of Norepinephrine > 40% during the entire period of treatment with the landiolol, - Unexpected cardiac arrest

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026