LANdiolol MIcrocirculatory Effects During Septic chOc (MILANOS)

Last updated: October 4, 2023
Sponsor: Assistance Publique - Hôpitaux de Paris
Overall Status: Active - Recruiting

Phase

3

Condition

Low Blood Pressure (Hypotension)

Sepsis And Septicemia

Treatment

Landiolol

Clinical Study ID

NCT04931225
APHP191047
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Sinus tachycardia not compensatory, if the doctor considers that the heart rateacceleration 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 (suspectedinfection + 2 SOFA points) according to the latest international definition andthe need to receive noradrenaline to maintain an average blood pressure above 65mmHg
  • Patient supported for at least 6 hours, necessary for diagnostic management andhemodynamic 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 ofnorepinephrine in the previous two hours to limit the risk of hypotension inducedby Landiolol infusion.
  • Age >18 years
  • Patient (or family member) informed consent signature or emergency consent
  • Affiliation to a social security system

Exclusion

Exclusion Criteria:

  • 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, sodiumhydroxide)
  • 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 beingin the exclusion period following a previous research involving the human person, ifapplicable
  • Ward or curative patient
  • Moribund patient
  • Estimated life expectancy less than 1 month

Study Design

Total Participants: 44
Treatment Group(s): 1
Primary Treatment: Landiolol
Phase: 3
Study Start date:
July 18, 2022
Estimated Completion Date:
January 31, 2024

Study Description

This is a Phase 3, prospective, randomized, open label, evaluation of the efficacy of continuous intravenous Landiolol injection up to a 15% decrease in HR on microcirculatory vascular reactivity vs. usual tachycardia management.

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.

Connect with a study center

  • Intensive care department, Hôpital Saint Antoine

    Paris, 75012
    France

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.