Comparing Landiolol to standard care for preventing death in septic shock patients with high heart rates
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
This study is testing if a heart medication called Landiolol can help save the lives of patients with septic shock who have high heart rates.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 360 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire, Amiens Academic / other |
| Locations | 1 site (Amiens) |
| Trial ID | NCT04748796 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are hospitalized for septic shock with specific hemodynamic criteria.
Not a fit: Patients who have been in septic shock for more than 36 hours or those currently receiving other beta-agonist treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce mortality rates in patients experiencing septic shock with tachycardia.
How similar studies have performed: While the use of Landiolol in this specific context is novel, previous studies have shown success with beta-blockers in managing tachycardia in critically ill patients.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Amiens
- CHU Amiens — Amiens, France (Recruiting)
Study contacts
- Study coordinator: Slama Michel, Pr
- Email: slama.michel@chu-amiens.fr
- Phone: 03 22 08 78 41
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.