LANdiolol MIcrocirculatory Effects During Septic chOc

Who is this study for? Patients with Septic Shock
What treatments are being studied? Landiolol
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Intensive care department, Hôpital Saint Antoine
RECRUITING
Paris
Contact Information
Primary
Hafid AIT-OUFELLA, Professor
hafid.aitoufella@aphp.fr
01 49 28 23 15
Time Frame
Start Date: 2022-07-18
Estimated Completion Date: 2026-07
Participants
Target number of participants: 44
Treatments
Experimental: Landiolol injection
Intravenous Landiolol injection (from 0.5 to 10 µg/kg/min during 12 hours) up to a 15% decrease in HR on microcirculatory vascular reactivity.
No_intervention: Usual tachycardia management
No treatment, usual tachycardia management.
Related Therapeutic Areas
Sponsors
Leads: Assistance Publique - Hôpitaux de Paris

This content was sourced from clinicaltrials.gov