NCT04931225

LANdiolol MIcrocirculatory Effects During Septic chOc (MILANOS)

LANdiolol MIcrocirculatory Effects During Septic chOc

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Septic Shock

Interventions

Type	Name	Description
DRUG	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.

Timeline

• Start date: 2022-07-18
• Primary completion: 2026-07-01
• Completion: 2026-07-01
• First posted: 2021-06-18
• Last updated: 2025-08-01

Locations

1 site across 1 country: France