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Recruiting NCT04748796

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

Phase III Interventional Septic Shock Tachycardia Mortality During Septic Shock Beta-blocker

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: echocardiography, Landiolol.
Who it may be relevant to
Registry conditions: Septic Shock, Tachycardia, Mortality During Septic Shock, Beta-blocker. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Other echocardiography
    Full echocardiography will be performed at baseline and during the follow-up at H1, H3, H6 and H12.
  • Drug Landiolol
    Patients randomized to the experimental group will be treated according to the standard of care plus for 2 days with landiolol IV started at a dose of 1 microgram/kg/min and progressively increased every 10 minutes to a maximum of 40 micrograms/kg/min.

Primary outcome measures

  • Variation of mortality rate in landiolol group compared to control group [Time frame: day 28]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

France · 1 center
  • CHU Amiens — Amiens

Identifiers

NCT: NCT04748796 · PI2020_843_0057

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗