Comparison of Landiolol Versus Standard of Care for Preve... | NCT04748796 | Trialant
NCT04748796
Sponsor
Centre Hospitalier Universitaire, Amiens
Status
Recruiting
Last Update Posted
Aug 24, 2025Actual
Enrollment
360Estimated
Phase
Phase 3
Conditions
Septic Shock
Tachycardia
Mortality During Septic Shock
Beta-blocker
Interventions
echocardiography
Landiolol
Countries
France
Protocol Section
Identification Module
NCT ID
NCT04748796
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
PI2020_843_0057
Secondary IDs
Not provided
Brief Title
Comparison of Landiolol Versus Standard of Care for Prevention of Mortality in Patients Hospitalized for a Septic Shock With Hypercontractility
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
Acronym
HyperBetashock
Organization
Centre Hospitalier Universitaire, AmiensOTHER
Status Module
Record Verification Date
Aug 2025
Overall Recruitment Status or Expanded Access Status
Recruiting
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Feb 1, 2021Actual
Primary Completion Date
Jun 2027Estimated
Completion Date
Sep 2027Estimated
First Submitted Date
Jan 27, 2021
First Submission Date that Met QC Criteria
Feb 8, 2021
First Posted Date
Feb 10, 2021Actual
Results Waived
Not provided
Results First Submitted Date
Not provided
Results First Submitted that Met QC Criteria
Not provided
Results First Posted Date
Not provided
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Aug 19, 2025
Last Update Posted Date
Aug 24, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Centre Hospitalier Universitaire, AmiensOTHER
Collaborators
Name
Class
CH Dieppe
UNKNOWN
CH Elbeuf
UNKNOWN
CH Le Havre
UNKNOWN
Centre Hospitalier de Beauvais
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
No
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
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.
Detailed Description
Not provided
Conditions Module
Conditions
Septic Shock
Tachycardia
Mortality During Septic Shock
Beta-blocker
Keywords
Septic Shock
Tachycardia
mortality during septic shock
beta-blocker
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
360Estimated
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Experimental group
Experimental
2 days with landiolol IV + usual care
Drug: Landiolol
Control group
Active Comparator
usual care according to the attending physician and following the guidelines of surviving sepsis campaign.
Other: echocardiography
Interventions
Name
Type
Description
Arm Group Labels
Other Names
echocardiography
Other
Full echocardiography will be performed at baseline and during the follow-up at H1, H3, H6 and H12.
Control group
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Variation of mortality rate in landiolol group compared to control group
day 28
Secondary Outcomes
Not provided
Other Outcomes
Not provided
Eligibility Module
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.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Name
Role
Phone
Extension
Email
Slama Michel, Pr
Contact
03 22 08 78 41
slama.michel@chu-amiens.fr
Overall Officials
Not provided
Locations
Facility
Status
City
State
ZIP
Country
Contacts
CHU Amiens
Recruiting
Amiens
80480
France
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
Plan to Share IPD
No
Description
Not provided
Types
Not provided
Time Frame
Not provided
Access Criteria
Not provided
URL
Not provided
Results Section
No data available
No data is available for this block.
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
OTHER
CH Compiègne
UNKNOWN
CH Laon
UNKNOWN
University Hospital, Caen
OTHER
CH Cherbourg
UNKNOWN
University Hospital, Lille
OTHER
CH Douai
UNKNOWN
CH Montreuil
UNKNOWN
Centre Hospitalier de Roubaix
OTHER
Centre Hospitalier de Bethune
NETWORK
CH Lomme
UNKNOWN
Centre Hospitalier de Lens
OTHER
Tourcoing Hospital
OTHER
Centre Hospitalier VALENCIENNES
OTHER
Centre Hospitalier Arras
OTHER
Hospital Ambroise Paré Paris
OTHER
University Hospital, Brest
OTHER
Henri Mondor University Hospital
OTHER
Hospital Avicenne
OTHER
University Hospital, Montpellier
OTHER
CH Calais
UNKNOWN
Hôpital Edouard Herriot
OTHER
Centre Hospitalier Universitaire de Nīmes
OTHER
Groupe Hospitalier Pitie-Salpetriere
OTHER
Hôpital Louis Mourier, Colombes
UNKNOWN
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Landiolol
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.