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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

360 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-01

Study Completion Date

2027-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Septic Shock Tachycardia Mortality During Septic Shock Beta-blocker

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Experimental group

2 days with landiolol IV + usual care

Group Type EXPERIMENTAL

Landiolol

Intervention Type DRUG

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.

Control group

usual care according to the attending physician and following the guidelines of surviving sepsis campaign.

Group Type ACTIVE_COMPARATOR

echocardiography

Intervention Type OTHER

Full echocardiography will be performed at baseline and during the follow-up at H1, H3, H6 and H12.

Interventions

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echocardiography

Full echocardiography will be performed at baseline and during the follow-up at H1, H3, H6 and H12.

Intervention Type OTHER

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.

Intervention Type DRUG

Eligibility Criteria

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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

* Patient treated with Dobutamine, adrenaline or isoprenaline

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No