Comparison of Landiolol versus standard of care for prevention of mortality in patients hospitalized for a septic shock with hypercontractlity: an open label prospective randomized study

Comparison of Landiolol versus standard of care for prevention of mortality in patients hospitalized for a septic shock with hypercontractlity: an open label prospective randomized study - Hyper-Betashock

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-002671-34-FR

Enrollment

360

Registered

2020-07-06

Start date

2020-12-04

Completion date

Unknown

Last updated

2024-10-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

septic shock with hypercontractlity

Interventions

Trade Name: RAPIBLOC 300 mg Product Name: Landiolol Pharmaceutical Form: Powder for injection

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Age = 18 years old - Patient admitted for a septic shock (according to the SEPSIS3 definition: sepsis with persisting hypotension (MAP65mmHg 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 > or = 65mmHg for more than 1 hour - Patient receiving invasive mechanical ventilation Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 300 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60

Exclusion criteria

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 - Hypersensitivity to the active substance or to any of the excipients

Design outcomes

Primary

Measure	Time frame
Main Objective: to demonstrate that the reduction of heart rate using the landiolol may improve the mortality of septic shock patients with tachycardia and hypercontractility in comparison to control group at day 28;Secondary Objective: Secondary objectives are to demonstrate that the reduction of heart rate using the landiolol in comparison to standard of care may: - Reduce tachycardia - Reduce hypercontractility - Reduce shock duration - Reduce the length of stay - Reduce the multi organ failure - Reduce the incidence of atrial fibrillation;Primary end point(s): mortality at day 28;Timepoint(s) of evaluation of this end point: at day 28	—

Measure

Time frame

Main Objective: to demonstrate that the reduction of heart rate using the landiolol may improve the mortality of septic shock patients with tachycardia and hypercontractility in comparison to control group at day 28;Secondary Objective: Secondary objectives are to demonstrate that the reduction of heart rate using the landiolol in comparison to standard of care may: - Reduce tachycardia - Reduce hypercontractility - Reduce shock duration - Reduce the length of stay - Reduce the multi organ failure - Reduce the incidence of atrial fibrillation;Primary end point(s): mortality at day 28;Timepoint(s) of evaluation of this end point: at day 28

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Secondary

Measure	Time frame
Secondary end point(s): - Number of patients that achieved a reduction of heart rate equal or higher to 20% of the initial HR with landiolol - Number of days receiving catecholamines - Number of days receiving mechanical ventilation - Length of stay in ICU and hospital - SOFA score at inclusion and day 1, 2, 3, 7, 14 and 28 following the inclusion - Number of patients developing atrial fibrillation of flutter during the first three days - Hospital mortality - Safety: number of episodes of bradycardia ( 40% during the entire period of treatment with the landiolol - Unexpected cardiac arrest;Timepoint(s) of evaluation of this end point: at day 28	—

Measure

Time frame

Secondary end point(s): - Number of patients that achieved a reduction of heart rate equal or higher to 20% of the initial HR with landiolol - Number of days receiving catecholamines - Number of days receiving mechanical ventilation - Length of stay in ICU and hospital - SOFA score at inclusion and day 1, 2, 3, 7, 14 and 28 following the inclusion - Number of patients developing atrial fibrillation of flutter during the first three days - Hospital mortality - Safety: number of episodes of bradycardia ( 40% during the entire period of treatment with the landiolol - Unexpected cardiac arrest;Timepoint(s) of evaluation of this end point: at day 28

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Countries

France

Contacts

Public ContactPoject Manager

CHU Amiens-Picardie

mattoug.salah@chu-amiens.fr

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026