Last updated: October 4, 2023
Sponsor: Assistance Publique - Hôpitaux de Paris
Overall Status: Active - Recruiting
Phase
3
Condition
Low Blood Pressure (Hypotension)
Sepsis And Septicemia
Treatment
Landiolol
Clinical Study ID
NCT04931225
APHP191047
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Sinus tachycardia not compensatory, if the doctor considers that the heart rateacceleration 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 (suspectedinfection + 2 SOFA points) according to the latest international definition andthe need to receive noradrenaline to maintain an average blood pressure above 65mmHg
- Patient supported for at least 6 hours, necessary for diagnostic management andhemodynamic 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 ofnorepinephrine in the previous two hours to limit the risk of hypotension inducedby Landiolol infusion.
- Age >18 years
- Patient (or family member) informed consent signature or emergency consent
- Affiliation to a social security system
Exclusion
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, sodiumhydroxide)
- 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 beingin the exclusion period following a previous research involving the human person, ifapplicable
- Ward or curative patient
- Moribund patient
- Estimated life expectancy less than 1 month
Study Design
Total Participants: 44
Treatment Group(s): 1
Primary Treatment: Landiolol
Phase: 3
Study Start date:
July 18, 2022
Estimated Completion Date:
January 31, 2024
Study Description
Connect with a study center
Intensive care department, Hôpital Saint Antoine
Paris, 75012
FranceActive - Recruiting
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