NCT04931225 LANdiolol MIcrocirculatory Effects During Septic chOc (MILANOS)
| NCT ID | NCT04931225 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Assistance Publique - Hôpitaux de Paris |
| Condition | Septic Shock |
| Study Type | INTERVENTIONAL |
| Enrollment | 44 participants |
| Start Date | 2022-07-18 |
| Primary Completion | 2026-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 44 participants in total. It began in 2022-07-18 with a primary completion date of 2026-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion 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 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 Exclusion Criteria: * 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
Contact & Investigator
Hafid AIT-OUFELLA, Professor
PRINCIPAL INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Frequently Asked Questions
Who can join the NCT04931225 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Septic Shock. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04931225 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 44 participants.
Is NCT04931225 currently recruiting?
Yes, NCT04931225 is actively recruiting participants. Contact the research team at hafid.aitoufella@aphp.fr for enrollment information.
Where is the NCT04931225 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT04931225 clinical trial?
NCT04931225 is sponsored by Assistance Publique - Hôpitaux de Paris. The principal investigator is Hafid AIT-OUFELLA, Professor at Assistance Publique - Hôpitaux de Paris. The trial plans to enroll 44 participants.