Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT04931225

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Intensive care department, Hôpital Saint Antoine

Paris, France, 75012

Actively Recruiting

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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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LANdiolol MIcrocirculatory Effects During Septic chOc (MILANOS) | DecenTrialz