LANdiolol MIcrocirculatory Effects During Septic chOc (MILANOS)
LANdiolol MIcrocirculatory Effects During Septic chOc
Assistance Publique - Hôpitaux de Paris
44 participants
Jul 18, 2022
INTERVENTIONAL
Conditions
Summary
The objectives of this study are to evaluate the effect of continuous intravenous Landiolol injection (from 0.5 to 10 µg/kg/min during 12 hours ) up to a 15% decrease in Heart Rate (HR) on microcirculatory vascular reactivity vs. usual tachycardia management and evaluate the hemodynamic effects of Landiolol vs. usual management in patients with septic shock.
Eligibility
Inclusion Criteria8
- Sinus tachycardia not compensatory, if the doctor considers that the heart rate acceleration should be treated.
- 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 Criteria15
- Asthma
- 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
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Interventions
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.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04931225