Actively Recruiting
Comparison of Landiolol Versus Standard of Care for Prevention of Mortality in Patients Hospitalized for a Septic Shock With Hypercontractility
Led by Centre Hospitalier Universitaire, Amiens · Updated on 2025-08-24
360
Participants Needed
1
Research Sites
343 weeks
Total Duration
On this page
Sponsors
C
Centre Hospitalier Universitaire, Amiens
Lead Sponsor
C
CH Dieppe
Collaborating Sponsor
AI-Summary
What this Trial Is About
Several data emphasize the relation between tachycardia (\>90/min) and high mortality during septic shock. The investigators previously demonstrated the high mortality associated with hypercontractility, tachycardia and the presence of a left ventricular obstruction. A severe hypovolemia, a hyper adrenergic stimulation or a severe vasoplegia can all explain this relation between tachycardia, hypercontractility and the mortality during septic shock. Landiolol is another short-term acting beta-blocker with a half-life of 4 minutes without any beta 2 activity or membrane stabilizing effect. The landiolol has been used in critically ill patients to control supraventricular tachycardia but not in this context of tachycardia and septic shock. The investigators hypothesize that landiolol by reducing the heart rate may improve the survival of patients treated for a septic shock and presenting with an hypercontractility state.
CONDITIONS
Official Title
Comparison of Landiolol Versus Standard of Care for Prevention of Mortality in Patients Hospitalized for a Septic Shock With Hypercontractility
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosed with septic shock according to SEPSIS3 definition (low blood pressure requiring vasopressors and serum lactate >2 mmol/L)
- Received at least 30 ml/kg of fluids and no longer responsive to fluid treatment
- Left ventricular ejection fraction greater than 65% measured by echocardiography
- Tachycardia over 100 beats per minute in sinus rhythm with mean arterial pressure of 65 mmHg for more than 1 hour
- Receiving invasive mechanical ventilation
- Sedated and adapted to ventilator support
- Provided written informed consent
- Covered by French national health insurance
You will not qualify if you...
- Inclusion criteria present for more than 36 hours before enrollment
- Treatment with Dobutamine, adrenaline, or isoprenaline
- Current treatment with beta blockers (home use previously allowed)
- Presence of supraventricular or ventricular arrhythmias (atrial fibrillation or flutter)
- Use of any cardiac pacemaker
- Sick sinus syndrome
- Severe atrioventricular nodal conduction disorders without pacemaker (2nd or 3rd degree AV block)
- Known pulmonary hypertension
- Mixed venous oxygen saturation below 70%
- Moribund condition
- Cardiac arrest
- Untreated pheochromocytoma
- Acute asthmatic attack
- Pregnant or breastfeeding women
- Patients under legal protection or deprived of liberty
- Age under 18 years
- Hypersensitivity to landiolol or its ingredients
- Severe bradycardia (heart rate less than 50 bpm)
- Cardiogenic shock
- Severe hypotension
- Decompensated heart failure unrelated to arrhythmia
- Severe uncorrectable metabolic acidosis
- Significant bleeding
- Acute respiratory distress with increased oxygen needs or breathing difficulty if not intubated and ventilated
AI-Screening
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Trial Site Locations
Total: 1 location
1
CHU Amiens
Amiens, France, 80480
Actively Recruiting
Research Team
S
Slama Michel, Pr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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