Status:
RECRUITING
Comparison of Landiolol Versus Standard of Care for Prevention of Mortality in Patients Hospitalized for a Septic Shock With Hypercontractility
Lead Sponsor:
Centre Hospitalier Universitaire, Amiens
Collaborating Sponsors:
CH Dieppe
CH Elbeuf
Conditions:
Septic Shock
Tachycardia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Several data emphasize the relation between tachycardia (\>90/min) and high mortality during septic shock. The investigators previously demonstrated the high mortality associated with hypercontractili...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
360 Patients enrolled
Trial Details
Trial ID
NCT04748796
Start Date
February 1 2021
End Date
September 1 2027
Last Update
August 24 2025
Active Locations (1)
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1
CHU Amiens
Amiens, France, 80480