LANdiolol MIcrocirculatory Effects During Septic chOc (MILANOS)

Официальное название

LANdiolol MIcrocirculatory Effects During Septic chOc

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат 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.

Первичные конечные точки

• Rate of decrease in heart rate (HR) on microcirculatory vascular reactivity [Срок оценки: 24 hours]

Вторичные конечные точки (5)

• Cardiac flow [Срок оценки: 24 hours]
• marbling score [Срок оценки: 24 hours]
• skin recoloration time [Срок оценки: 24 hours]
• Arterial lactate clearance [Срок оценки: 24 hours]
• Measure of Systemic and endothelial inflammation parameters [Срок оценки: 24 hours]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Франция · 1 центр

• Intensive care department, Hôpital Saint Antoine — Paris

Идентификаторы

NCT: NCT04931225 · APHP191047

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗