Comparison of Landiolol Versus Standard of Care for Prevention of Mortality in Patients Hospitalized for a Septic Shock With Hypercontractility

Launched by CENTRE HOSPITALIER UNIVERSITAIRE, AMIENS · Feb 8, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a medication called Landiolol to see if it can help improve survival rates in patients who are hospitalized with septic shock and a fast heart rate (tachycardia). Septic shock is a serious condition that occurs when an infection leads to dangerously low blood pressure and organ failure. The researchers believe that by using Landiolol to lower the heart rate, it may help patients in this critical state.

To participate in the trial, individuals must be at least 18 years old and have been admitted to the hospital for septic shock, which is defined by specific symptoms like low blood pressure and high levels of lactate in the blood. Participants should also be experiencing a rapid heart rate of over 100 beats per minute and require mechanical ventilation. If eligible, participants will receive either Landiolol or standard care, and their health will be monitored closely. It’s important to note that certain conditions may exclude individuals from participating, such as severe heart problems or specific arrhythmias. Overall, this trial aims to find a better treatment option for patients facing the challenges of septic shock.

Gender

ALL

Eligibility criteria

• 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.