LANdiolol MIcrocirculatory Effects During Septic chOc (MILANOS)
NCT ID: NCT04931225
Last Updated: 2025-08-01
Study Results
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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RECRUITING
PHASE3
44 participants
INTERVENTIONAL
2022-07-18
2026-07-31
Brief Summary
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Detailed Description
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Design:
A monocentric, open-label, randomised, superiority clinical trial
Sample size :
44 patients, 22 in each group
Treatments groups:
Continuous intravenous Landiolol injection ( from 0.5 to 10 µg/kg/min during 12 hours ) up to a 15% decrease in HR on microcirculatory vascular reactivity vs usual tachycardia management
Treatment duration :
24 hours
Assessement:
Landiolol (Rapibloc)'s perfusion will be started at T0 at 0.5 mcg/kg/min and increased by 0.5 mcg/kg/min every 30 minutes in order to achieve a 15% (T1) decrease in HR, within the limit of 10 mcg/kg/min. Then the dosage will be maintained for 2 hours (T2) then the drug will be stopped gradually over 2 hours.
Maximum duration of Landiolol infusion will be 12 hours.
No interim analysis is planned. Analysis will be performed at the end of the study after data review and freezing of database.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Landiolol injection
Intravenous Landiolol injection (from 0.5 to 10 µg/kg/min during 12 hours) up to a 15% decrease in HR on microcirculatory vascular reactivity.
Landiolol
Intravenous Landiolol injection (from 0.5 to 10 µg/kg/min during 12 hours) up to a 15% decrease in HR on microcirculatory vascular reactivity.
Usual tachycardia management
No treatment, usual tachycardia management.
No interventions assigned to this group
Interventions
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Landiolol
Intravenous Landiolol injection (from 0.5 to 10 µg/kg/min during 12 hours) up to a 15% decrease in HR on microcirculatory vascular reactivity.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* The study will be carried out in
* reanimated and stabilized septic shock defined as:
* Septic shock is tachycardic (HR\>100/min) patients with sepsis (suspected infection + 2 SOFA points) according to the latest international definition and the need to receive noradrenaline to maintain an average blood pressure above 65 mmHg
* Patient supported for at least 6 hours, necessary for diagnostic management and hemodynamic optimization according to international standards and for less than 24 hours to limit confounding factors related to prolonged reanimation (sedation) and empowerment of organ failure in general and vascular in particular. Hemodynamic stabilization will be defined as the absence of increased doses of norepinephrine in the previous two hours to limit the risk of hypotension induced by Landiolol infusion.
* Age \>18 years
* Patient (or family member) informed consent signature or emergency consent
* Affiliation to a social security system
Exclusion Criteria
* Patients treated with the following bradycardizing drugs:
* Digitalis
* Bradycardizing calcium channel blockers
* Cordarone
* Other beta-blocker
* Hypersensitivity to Landiolol or to one of its excipients (Mannitol E421, sodium hydroxide)
* Sinus disease
* Cardiogenic shock
* Decompensated heart failure when considered unrelated to arrhythmia
* Pregnant or nursing woman,
* Participation in another interventional research involving the human person or being in the exclusion period following a previous research involving the human person, if applicable
* Ward or curative patient
* Moribund patient
* Estimated life expectancy less than 1 month
18 Years
ALL
No
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Hafid AIT-OUFELLA, Professor
Role: PRINCIPAL_INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Locations
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Intensive care department, Hôpital Saint Antoine
Paris, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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APHP191047
Identifier Type: -
Identifier Source: org_study_id
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