LANDIOLOL HYDROCHLORIDE for Septic shock|Microcirculatory dysfunction

Inclusion criteria

• {"criterion_text":"-Non-compensatory sinus tachycardia, if the doctor considers that the accelerated heart rate needs to be treated.\n-The study will be carried out in patients in :resuscitated and stabilized septic shock defined by : •\tSeptic shock corresponds to tachycardic patients (HR>100/min) with sepsis (suspected infection + 2 SOFA points) according to the latest international definition (Singer et al. JAMA 2016)) and the need to receive norepinephrine to maintain a mean arterial pressure above 65 mmHg •\tPatient managed for at least 6 hours, necessary for diagnostic management and hemodynamic optimization according to international standards (Dellinger et al. Crit Care Med 2013) and for less than 24 hours to limit confounding factors related to prolonged resuscitation (sedation) and empowerment of organ failure in general and vascular failure in particular. Hemodynamic stabilization will be defined as the absence of an increase in norepinephrine dosages in the previous two hours to limit the risk of arterial hypotension induced by Landiolol infusion.\n-Signature of patient's (or family member's) informed consent or emergency consent.\n-Age ≥ 18 years\n-Social Security affiliation"}

Exclusion criteria

• {"criterion_text":"-Asthma\n-Moribund patient\n-Estimated life expectancy less than 1 month\n-Patients with severe atrioventricular conduction disorders (without pacemaker)\n-Second- and third-degree atrioventricular blocks\n-Pulmonary hypertension\n-Untreated pheochromocytoma\n-Moribund patients with very severe acidosis\n-Left ventricular ejection fraction <30%.\n-Patients treated with the following bradycardia drugs : Digitalis, Bradycardia-inducing, calcium channel blockers, Cordarone, Other beta-blockers\n-Hypersensitivity to Landiolol or any of its excipients (Mannitol E421, sodium hydroxide)\n-Sinus disease\n-Cardiogenic shock\n-Decompensated heart failure when considered unrelated to arrhythmia\n-Pregnant or breast-feeding women\n-Participation in other interventional research involving the human person or being within the exclusion period following previous research involving the human person, if applicable\n-Patients under guardianship or trusteeship"}

Primary endpoints

• {"endpoint_text":"-Variation (%) in microcirculatory vascular reactivity (T2-T0/T0x100).","definition_or_measurement_approach":"Calculated as (T2 - T0) / T0 x 100 (change in microcirculatory vascular reactivity between timepoints T0 and T2)."}

Secondary endpoints

• {"endpoint_text":"-Variation (%) in cardiac output (echocardiography)","definition_or_measurement_approach":"Percentage change in cardiac output measured by echocardiography between specified timepoints."}
• {"endpoint_text":"-Variation (%) in clinical perfusion parameters between T0 and T2: mottling score, skin recoloration time, hourly diuresis","definition_or_measurement_approach":"Percentage change in listed clinical perfusion parameters (mottling score, skin recoloration time, hourly diuresis) between T0 and T2."}
• {"endpoint_text":"-Variation (%) in arterial lactate clearance between T0 and T2","definition_or_measurement_approach":"Percentage change in arterial lactate clearance between T0 and T2."}
• {"endpoint_text":"-Variation (%) in systemic and endothelial inflammation parameters between T0 and T2 : Plasma cytokines (Procartaplex), VCAM-1 soluble, Soluble Endocan","definition_or_measurement_approach":"Percentage change in listed biomarkers (plasma cytokines by Procartaplex, VCAM-1 soluble, soluble Endocan measured by ELISA) between T0 and T2."}

France

Earliest CTIS Part Ii Submission Date

27-09-2024

Latest Decision Or Authorization Date

18-07-2025

Processing Time Days

294

Number Of Sites

1

Number Of Participants

44

Primary sponsor

Full Name

Assistance Publique Hopitaux De Paris

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France