Evaluating Landiolol's effects on microcirculation in septic shock patients
LANdiolol MIcrocirculatory Effects During Septic chOc
This study is testing if giving a new heart medication called Landiolol can improve blood flow in patients with septic shock by lowering their heart rate compared to standard treatment.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 44 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris) |
| Trial ID | NCT04931225 on ClinicalTrials.gov |
What this trial studies
This Phase 3 clinical trial aims to assess the impact of continuous intravenous Landiolol infusion on microcirculatory vascular reactivity in patients experiencing septic shock. Participants will receive Landiolol to achieve a 15% reduction in heart rate, compared to standard tachycardia management. The study will involve a total of 44 patients, randomized into two groups, with one receiving Landiolol and the other receiving usual care. The treatment will last for 12 hours, and the effects on hemodynamics and microcirculation will be evaluated at the end of the study.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years with septic shock characterized by tachycardia and requiring norepinephrine support.
Not a fit: Patients who do not have sinus tachycardia or those who are not stabilized after resuscitation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve management strategies for septic shock, potentially enhancing patient outcomes through better microcirculatory function.
How similar studies have performed: While there is limited data on Landiolol's specific effects in septic shock, similar approaches in managing tachycardia have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Paris
- Intensive care department, Hôpital Saint Antoine — Paris, France (Recruiting)
Study contacts
- Principal investigator: Hafid AIT-OUFELLA, Professor — Assistance Publique - Hôpitaux de Paris
- Study coordinator: Hafid AIT-OUFELLA, Professor
- Email: hafid.aitoufella@aphp.fr
- Phone: 01 49 28 23 15
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.