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New treatment option for Septic Shock
Official title LANdiolol MIcrocirculatory Effects During Septic chOc (MILANOS)
ClinicalTrials.gov ID: NCT04931225
What this study is testing
What is Landiolol?
Landiolol is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for septic shock.
Also referred to as Rapibloc.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Patient supported for at least 6 hours, necessary for diagnostic management and hemodynamic optimization according to international standards and for...
You likely can't join if
- Asthma
- Patients treated with the following bradycardizing drugs:
- Digitalis
- Bradycardizing calcium channel blockers
- Cordarone
- Other beta-blocker
See the full eligibility criteria
- 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...
- 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...
- Age \>18 years
- Patient (or family member) informed consent signature or emergency consent
- Affiliation to a social security system
- 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 treatment 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
The study team makes the final eligibility decision.
Where it's taking place
- Paris, France
Compensation & support
A stipend or compensation may be offered.
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Paris, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.