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

Primary Purpose

Septic Shock, Tachycardia, Mortality During Septic Shock

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
echocardiography
Landiolol
Sponsored by
Centre Hospitalier Universitaire, Amiens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Septic Shock focused on measuring Septic Shock, Tachycardia, mortality during septic shock, beta-blocker

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • CHU AmiensRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental group

Control group

Arm Description

2 days with landiolol IV + usual care

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

Outcomes

Primary Outcome Measures

Variation of mortality rate in landiolol group compared to control group

Secondary Outcome Measures

Full Information

First Posted
January 27, 2021
Last Updated
February 9, 2023
Sponsor
Centre Hospitalier Universitaire, Amiens
Collaborators
CH Dieppe, CH Elbeuf, CH Le Havre, Centre Hospitalier de Beauvais, CH Compiègne, CH Laon, University Hospital, Caen, CH Cherbourg, University Hospital, Lille, CH Douai, CH Montreuil, Centre Hospitalier de Roubaix, Centre Hospitalier de Bethune, CH Lomme, Centre Hospitalier de Lens, Tourcoing Hospital, Centre Hospitalier VALENCIENNES, Centre Hospitalier Arras, Hospital Ambroise Paré Paris, University Hospital, Brest, Henri Mondor University Hospital, Hospital Avicenne, University Hospital, Montpellier, CH Calais, Hôpital Edouard Herriot, Centre Hospitalier Universitaire de Nīmes, Groupe Hospitalier Pitié-Salpêtrière
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1. Study Identification

Unique Protocol Identification Number
NCT04748796
Brief Title
Comparison of Landiolol Versus Standard of Care for Prevention of Mortality in Patients Hospitalized for a Septic Shock With Hypercontractility
Acronym
HyperBetashock
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens
Collaborators
CH Dieppe, CH Elbeuf, CH Le Havre, Centre Hospitalier de Beauvais, CH Compiègne, CH Laon, University Hospital, Caen, CH Cherbourg, University Hospital, Lille, CH Douai, CH Montreuil, Centre Hospitalier de Roubaix, Centre Hospitalier de Bethune, CH Lomme, Centre Hospitalier de Lens, Tourcoing Hospital, Centre Hospitalier VALENCIENNES, Centre Hospitalier Arras, Hospital Ambroise Paré Paris, University Hospital, Brest, Henri Mondor University Hospital, Hospital Avicenne, University Hospital, Montpellier, CH Calais, Hôpital Edouard Herriot, Centre Hospitalier Universitaire de Nīmes, Groupe Hospitalier Pitié-Salpêtrière

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Septic Shock, Tachycardia, Mortality During Septic Shock, Beta-blocker
Keywords
Septic Shock, Tachycardia, mortality during septic shock, beta-blocker

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
360 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
2 days with landiolol IV + usual care
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
usual care according to the attending physician and following the guidelines of surviving sepsis campaign.
Intervention Type
Other
Intervention Name(s)
echocardiography
Intervention Description
Full echocardiography will be performed at baseline and during the follow-up at H1, H3, H6 and H12.
Intervention Type
Drug
Intervention Name(s)
Landiolol
Intervention Description
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 Measure Information:
Title
Variation of mortality rate in landiolol group compared to control group
Time Frame
day 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Slama Michel, Pr
Phone
03 22 08 78 41
Email
slama.michel@chu-amiens.fr
Facility Information:
Facility Name
CHU Amiens
City
Amiens
ZIP/Postal Code
80480
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michel Slama, Pr
Phone
(33)3 22 08 78 41
Email
slama.michel@chu-amiens.fr
First Name & Middle Initial & Last Name & Degree
Julien Maizel, Pr
Phone
(33)3 22 08 78 07
Email
maizel.julien@chu-amiens.fr
First Name & Middle Initial & Last Name & Degree
Julien Maizel, Pr
First Name & Middle Initial & Last Name & Degree
Herve Dupont, Pr
First Name & Middle Initial & Last Name & Degree
Pierre Louis DECLERCQ, MD
First Name & Middle Initial & Last Name & Degree
Jean Louis CHAUVET, MD
First Name & Middle Initial & Last Name & Degree
Mehdi BOUSTA, MD
First Name & Middle Initial & Last Name & Degree
David LUIS, MD
First Name & Middle Initial & Last Name & Degree
Geneviève BARJON, MD
First Name & Middle Initial & Last Name & Degree
Eloi GOULLIEUX, MD
First Name & Middle Initial & Last Name & Degree
Damien DU CHEYRON, MD
First Name & Middle Initial & Last Name & Degree
Bertrand SAUNEUF, MD
First Name & Middle Initial & Last Name & Degree
Saad NSEIR, MD
First Name & Middle Initial & Last Name & Degree
Philippe MOREL, MD
First Name & Middle Initial & Last Name & Degree
Jérôme LEPRETRE, MD
First Name & Middle Initial & Last Name & Degree
Patrick HERBECQ, MD
First Name & Middle Initial & Last Name & Degree
Christophe VINSONNEAU, MD
First Name & Middle Initial & Last Name & Degree
Thierry VANDERLINDEN, MD
First Name & Middle Initial & Last Name & Degree
Didier THEVENIN, MD
First Name & Middle Initial & Last Name & Degree
Olivier LEROY, MD
First Name & Middle Initial & Last Name & Degree
Fabien LAMBIOTTE, MD
First Name & Middle Initial & Last Name & Degree
Maxime GRANIER, MD
First Name & Middle Initial & Last Name & Degree
Antoine VIEILLARD BARON, MD
First Name & Middle Initial & Last Name & Degree
Gwenael PRAT, MD
First Name & Middle Initial & Last Name & Degree
Armand MEKONTSO DESSAP, MD
First Name & Middle Initial & Last Name & Degree
Stephane GAUDRY, MD
First Name & Middle Initial & Last Name & Degree
Kada KLOUCHE, MD
First Name & Middle Initial & Last Name & Degree
Joseph BAYEKULA MAFULA, MD
First Name & Middle Initial & Last Name & Degree
Bernard ALLAOUCHICHE, MD
First Name & Middle Initial & Last Name & Degree
Laurent MULLER, MD
First Name & Middle Initial & Last Name & Degree
Jean-Michel CONSTANTIN, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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