Evaluating Landiolol's effects on microcirculation in septic shock patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Adjunctive Fludrocortisone in Septic Shock on Hydrocortisone

  In septic shock, this trial tests whether adding fludrocortisone (50 mcg or 100 mcg daily) to hydrocortisone improves survival and recovery compared with placebo.

  Recruiting at 2 sites Phase 3 The George Institute · Penrith, New South Wales and 7 other locations · NCT07898462

• Non-invasive hemodynamic guidance for sepsis care on medical wards

  This trial tests whether guiding fluid and vasopressor therapy for sepsis using non-invasive hemodynamic measurements works better than standard care.

  Recruiting at 2 sites Regione del Veneto - AULSS n. 7 Pedemontana · Pisa, Pisa and 1 other locations · NCT07863323

• Reducing Endotoxin Burden in Septic Shock Patients on CRRT with the oXiris Filter

  This trial tests whether using the oXiris hemofilter during continuous kidney replacement helps lower endotoxin levels in adults with septic shock who need CRRT.

  Recruiting Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Guangzhou, Guangdong · NCT07807410

• Personalized Fluid Resuscitation in the Emergency Department

  This pilot test checks if a quick, non-invasive stroke-volume assessment can help ED doctors tailor IV fluids for septic patients with low blood pressure.

  Recruiting Intermountain Health Care, Inc. · Murray, Utah · NCT07779720

• Discordance between capillary refill time and oxygen use in septic shock

  This study tests whether some septic shock patients can have a normal capillary refill time but still lack tissue oxygen use, to see if that mismatch relates to 28-day survival.

  Recruiting Istanbul University - Cerrahpasa · Istanbul · NCT07774962

• Targeting upper-normal magnesium to see if norepinephrine needs drop in septic shock

  This trial tests whether keeping magnesium levels at the upper end of normal can reduce the amount and duration of norepinephrine needed in adults with septic shock.

  Recruiting Alexandria University · Alexandria, Alexandria Governorate · NCT07716956

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.