Comparing Landiolol to standard care for preventing death in septic shock patients with high heart rates

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 clinical trial aims to evaluate the effectiveness of Landiolol, a short-acting beta-blocker, in reducing mortality among patients hospitalized for septic shock who exhibit tachycardia and hypercontractility. The study will involve patients who meet specific criteria, including persistent hypotension and elevated serum lactate levels, and will assess the impact of Landiolol on heart rate and survival outcomes. Participants will receive echocardiography and be monitored closely during the intervention. The hypothesis is that controlling heart rate with Landiolol may improve survival rates in this critical patient population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥ 18 years old
* Patient admitted for a septic shock (according to the SEPSIS3 definition: sepsis with persisting hypotension (MAP\<65mmHg or SAP \<90mmHg) requiring vasopressors to maintain MAP\>65mmHg and having a serum lactate level \>2 mmol/L
* Patient who received at least 30ml/kg of fluid and absence of fluid responsiveness
* Left ventricular ejection fraction \>65% (visual or Simpson method using echocardiography)
* Tachycardia \>100 bpm in sinus rhythm with a MAP 65mmHg for more than 1 hour
* Patient receiving invasive mechanical ventilation
* Patients adapted to the ventilator under sedation and analgesia
* Written informed consent
* Patient covered by French national health insurance

Exclusion Criteria:

* Patients with inclusion criteria already present for more than 36 hours
* Patient treated with Dobutamine, adrenaline or isoprenaline
* Patient currently treated with beta blockers (previous home betablocker treatment is not an exclusion criteria)
* Supra ventricular (atrial fibrillation or flutter) or ventricular arrhythmias
* Patients with any form of cardiac pacing
* Sick sinus syndrome
* Severe atrioventricular (AV) nodal conductance disorders (without pacemaker): 2nd or 3rd degree AV block
* Known pulmonary hypertension
* ScVO2 \<70%
* Moribund
* Cardiac arrest
* Non-treated phaeochromocytoma
* Acute asthmatic attack
* Pregnant or breastfeeding woman
* Patient deprived of liberty by administrative or judicial decision or placed under judicial protection (guardianship or supervision),
* Age \<18 years
* Hypersensitivity to the active substance or to any of the excipients
* Severe bradycardia (less than 50 beats per minute)
* Cardiogenic shock
* Severe hypotension
* Decompensated heart failure when considered not related to the arrhythmia
* Severe, uncorrectable metabolic acidosis
* Presence of significant bleeding, or
* Acute respiratory distress defined by increased oxygen dependency, polypnea \> 30 /min, signs of struggle (pulling, thoraco-abdominal sway) if the patient is not intubated and ventilated.

Where it's running

• CHU Amiens
  Amiens, France Recruiting

Study contacts

• Study coordinator: Slama Michel, Pr
• Email: slama.michel@chu-amiens.fr
• Phone: 03 22 08 78 41

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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.