Actively Recruiting
LANdiolol MIcrocirculatory Effects During Septic chOc (MILANOS)
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-08-01
44
Participants Needed
1
Research Sites
206 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
LANdiolol MIcrocirculatory Effects During Septic chOc (MILANOS)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Sinus tachycardia not compensatory, deemed necessary to treat by the doctor
- Reanimated and stabilized septic shock patients defined by tachycardia (HR >100/min) with sepsis (suspected infection plus 2 SOFA points) requiring noradrenaline to maintain mean blood pressure above 65 mmHg
- Patients supported for at least 6 hours and less than 24 hours for diagnostic management and hemodynamic optimization
- Hemodynamic stabilization defined as no increase in norepinephrine dose in the previous 2 hours
- Age over 18 years
- Signed informed consent by patient or family member or emergency consent
- Affiliated with a social security system
You will not qualify if you...
- Asthma
- Treatment with digitalis, bradycardizing calcium channel blockers, cordarone, or other beta-blockers
- Hypersensitivity to Landiolol or its excipients (Mannitol E421, sodium hydroxide)
- Sinus disease
- Cardiogenic shock
- Decompensated heart failure unrelated to arrhythmia
- Pregnant or nursing women
- Participation in another interventional human research or within exclusion period after previous research
- Ward or curative patient status
- Moribund patient
- Estimated life expectancy less than 1 month
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Intensive care department, Hôpital Saint Antoine
Paris, France, 75012
Actively Recruiting
Research Team
H
Hafid AIT-OUFELLA, Professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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