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LANdiolol MIcrocirculatory effects during Septic chOc (MILANOS)
EU CTIS ID: 2024-512757-24-00
What this study is testing
To study the efficacy of continuous intravenous infusion of Landiolol (0.5 to 10 μg/kg/min for 12 h) up to 15% lower HR on microcirculatory vascular reactivity vs. usual tachycardia management.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- -Non-compensatory sinus tachycardia, if the doctor considers that the accelerated heart rate needs to be treated.
- The study will be carried out in patients in :resuscitated and stabilized septic shock defined by : • Septic 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 • Patient 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.
- Signature of patient's (or family member's) informed consent or emergency consent.
- -Age ≥ 18 years
- Social Security affiliation
You likely can't join if
- -Asthma
- Moribund patient
- Estimated life expectancy less than 1 month
- Patients with severe atrioventricular conduction disorders (without pacemaker)
- -Second- and third-degree atrioventricular blocks
- Pulmonary hypertension
See the full eligibility criteria
- -Non-compensatory sinus tachycardia, if the doctor considers that the accelerated heart rate needs to be treated.
- The study will be carried out in patients in :resuscitated and stabilized septic shock defined by : • Septic 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 • Patient 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.
- Signature of patient's (or family member's) informed consent or emergency consent.
- -Age ≥ 18 years
- Social Security affiliation
- -Asthma
- Moribund patient
- Estimated life expectancy less than 1 month
- Patients with severe atrioventricular conduction disorders (without pacemaker)
- -Second- and third-degree atrioventricular blocks
- Pulmonary hypertension
- Untreated pheochromocytoma
- Moribund patients with very severe acidosis
- Left ventricular ejection fraction <30%.
- Patients treated with the following bradycardia drugs : Digitalis, Bradycardia-inducing, calcium channel blockers, Cordarone, Other beta-blockers
- Hypersensitivity to Landiolol or any of its excipients (Mannitol E421, sodium hydroxide)
- Sinus disease
- Cardiogenic shock
- Decompensated heart failure when considered unrelated to arrhythmia
- Pregnant or breast-feeding women
- Participation in other interventional research involving the human person or being within the exclusion period following previous research involving the human person, if applicable
- Patients under guardianship or trusteeship
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.