Actively Recruiting
Comparison of Landiolol Versus Standard of Care for Prevention of Mortality in Patients Hospitalized for a Septic Shock With Hypercontractility: an Open Label Prospective Randomized Study
Led by Centre Hospitalier Universitaire, Amiens · Updated on 2025-08-24
360
Participants Needed
1
Research Sites
13 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
Researchers are investigating the relationship between tachycardia (heart rate over 90 beats per minute) and high mortality in patients with septic shock. Previous findings suggest that tachycardia combined with hypercontractility and left ventricular obstruction may increase mortality risk. The study focuses on evaluating whether the beta-blocker landiolol, which reduces heart rate and has a short half-life, can improve survival in patients with septic shock and hypercontractility. Participants will be randomly assigned to one of two groups: an experimental group receiving landiolol intravenously for 2 days starting at 1 microgram/kg/min and increasing up to 40 micrograms/kg/min alongside usual care, or a control group receiving standard care as directed by their physician. Echocardiography will be conducted at baseline and several points during follow-up to monitor heart function. During the study, participants will undergo heart ultrasound evaluations at multiple time points within the first 12 hours. Researchers will measure mortality rates at day 28 to assess the effect of landiolol compared to standard care. The study includes patients aged 18 and older who are mechanically ventilated and have septic shock with tachycardia. Safety and treatment responses will be monitored throughout the trial, which is expected to continue until September 2027.
CONDITIONS
Brief 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 meeting SEPSIS3 criteria, requiring vasopressors to maintain mean arterial pressure >65 mmHg and serum lactate >2 mmol/L
- Received at least 30 ml/kg of fluids with no fluid responsiveness
- Left ventricular ejection fraction greater than 65% confirmed by echocardiography
- Tachycardia greater than 100 bpm in sinus rhythm for over 1 hour with mean arterial pressure above 65 mmHg
- Currently receiving invasive mechanical ventilation
- Adapted to ventilator under sedation and analgesia
- Provided written informed consent
- Covered by French national health insurance
You will not qualify if you...
- Inclusion criteria present for more than 36 hours
- Treatment with dobutamine, adrenaline, or isoprenaline
- Current treatment with beta blockers (prior home beta-blocker use allowed)
- Presence of supraventricular or ventricular arrhythmias
- Any form of cardiac pacing
- Sick sinus syndrome
- Severe atrioventricular conduction disorders without pacemaker (2nd or 3rd degree AV block)
- Known pulmonary hypertension
- ScVO2 less than 70%
- Moribund status
- Cardiac arrest
- Untreated phaeochromocytoma
- Acute asthmatic attack
- Pregnant or breastfeeding
- Subject under judicial protection or deprived of liberty
- 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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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 days
Participants receive standard care for septic shock. Those in the experimental group receive landiolol IV for 2 days with dose adjustments every 10 minutes, alongside usual care.
Continuous treatment with landiolol IV during hospitalization
Duration - 12 hours post-treatment start
Participants undergo echocardiography at baseline and during follow-up at 1, 3, 6, and 12 hours after treatment start to monitor heart function.
5 echocardiography assessments (1 baseline and 4 during follow-up)
Trial Site Locations
Total: 1 location
1
CHU Amiens
Amiens, France, 80480
Actively Recruiting
Research Team
S
Slama Michel, Pr
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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