Clinical trial • Cardiology|Infectious Disease

Landiolol hydrochloride for Septic shock with hypercontractility

Clinical trial of Landiolol hydrochloride for Septic shock with hypercontractility.

Overview

Trial Therapeutic Area
Cardiology|Infectious Disease
Trial Disease
Septic shock with hypercontractility
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
27-09-2024
First CTIS Authorization Date
22-10-2024

Trial design

Randomised, open-label, standard of care (control group); no specific drug name, dose or schedule for the comparator is specified in the record trial across 39 sites in France.

Randomised
Yes
Open Label
Yes
Comparator
Standard of care (control group); no specific drug name, dose or schedule for the comparator is specified in the record
Target Sample Size
360
Trial Duration For Participant
28

Eligibility

Recruits 360 Critically ill patients (including intubated and ventilated patients) are included; subject information and informed consent forms for patients and for representatives are provided (L1_SIS and ICF patient; L1_SIS and ICF_Representative and pursuit versions) and there is an attestation document for the investigator if a representative is unreachable, indicating consent via legally authorised representative processes for incapacitated participants..

Vulnerable Population
Critically ill patients (including intubated and ventilated patients) are included; subject information and informed consent forms for patients and for representatives are provided (L1_SIS and ICF patient; L1_SIS and ICF_Representative and pursuit versions) and there is an attestation document for the investigator if a representative is unreachable, indicating consent via legally authorised representative processes for incapacitated participants.

Inclusion criteria

  • {"criterion_text":"- Age ≥ 18 years old"}
  • {"criterion_text":"- Patient with a septic shock (according to the SEPSIS3 definition: sepsis with persisting hypotension (MAP<65mmHg or SAP <90mmHg) requiring vasopressors to maintain MAP>65mmHg with at least one lactate dosage >2 mmol/L during the current shock episode."}
  • {"criterion_text":"- patient who received between 10 and 30ml/kg of fluid and absence of fluid responsiveness"}
  • {"criterion_text":"- Left ventricular ejection fraction > 60 % (visual or Simpson method using echocardiography)"}
  • {"criterion_text":"- Tachycardia >95 bpm with a MAP 65mmHg for more than 1 hour"}
  • {"criterion_text":"- Patient either in spontaneous ventilation or intubated and ventilated"}

Exclusion criteria

  • {"criterion_text":"- Patients with inclusion criteria already present for more than 36 hours"}
  • {"criterion_text":"- Non-treated phaeochromocytoma"}
  • {"criterion_text":"- Acute asthmatic attack"}
  • {"criterion_text":"- Hypersensitivity to the active substance or to any of the excipients"}
  • {"criterion_text":"- Severe bradycardia (less than 50 beats per minute)"}
  • {"criterion_text":"- Cardiogenic shock"}
  • {"criterion_text":"- Severe hypotension uncontrolled"}
  • {"criterion_text":"- Decompensated heart failure when considered not related to the errhythmia"}
  • {"criterion_text":"- Severe, uncorrectable metabolic acidosis"}
  • {"criterion_text":"- Presence of significant bleeding, or spontaneously ventilated patient in respiratory distress requiring immediate intubation"}
  • {"criterion_text":"- Patient treated with Dobutamine, adrenaline or isoprenaline"}
  • {"criterion_text":"- Patient currently treated with beta blockers (previous home betablocker treatment is not an exclusion criteria)"}
  • {"criterion_text":"- Patients with any form of cardiac pacing"}
  • {"criterion_text":"- Sick sinus syndrome"}
  • {"criterion_text":"- Severe atrioventricular (AV) nodal conductance disorders (without pacemaker): 2nd or 3rd degree AV block"}
  • {"criterion_text":"- Known pulmonary hypertension"}
  • {"criterion_text":"- Moribund"}
  • {"criterion_text":"- in- or out-of-hospital cardiac arrest without signs of early recovery"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- mortality at day 28","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"- Number of patients that achieved a reduction of heart rate equal or higher to 20% of the initial HR with landiolol","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Number of days receiving catecholamines","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Number of days receiving mechanical ventilation","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Length of stay in ICU and hospital","definition_or_measurement_approach":""}
  • {"endpoint_text":"- SOFA score at inclusion and day 1, 2, 3, 7, 14 and 28 following the inclusion","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Number of patients developing atrial fibrillation of flutter during the first three days","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Hospital mortality","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Number of episodes of bradycardia (<50 bpm) or LVEF < 45% or MAP <65mmHg requiring an increase of Norepinephrine > 40% during the entire period of treatment with the landiolol","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Unexpected cardiac arrest","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
360
Recruitment Window Months
49
Consent Approach
Informed consent is handled via patient information and consent forms (L1_SIS and ICF patient) when the patient is capable; for incapacitated patients there are representative ICF documents (L1_SIS and ICF_Representative and pursuit versions) and an attestation document for situations where the investigator's representative is unreachable, indicating consent via legally authorised representative procedures. Documents available in the application are the patient and representative ICFs and attestations (versions available).

Geography

Total Number Of Sites
39
Total Number Of Participants
360

France

Earliest CTIS Part Ii Submission Date
17-10-2024
Latest Decision Or Authorization Date
09-07-2025
Processing Time Days
265
Number Of Sites
39
Number Of Participants
360

Sites

Site Name
Centre Hospitalier Universitaire De Lille
Department Name
Anesthésie-réanimation
Principal Investigator Name
Sébastien PREAU
Principal Investigator Email
sebastien.preau@chru-lille.fr
Contact Person Name
Sébastien PREAU
Contact Person Email
sebastien.preau@chru-lille.fr
Site Name
Groupe Hospitalier Du Havre
Department Name
Anesthésie-réanimation
Principal Investigator Name
Mehdi BOUSTA
Principal Investigator Email
mehdi.bousta@ch-havre.fr
Contact Person Name
Mehdi BOUSTA
Contact Person Email
mehdi.bousta@ch-havre.fr
Site Name
Centre Hospitalier De Valenciennes
Department Name
Anesthésie-réanimation
Principal Investigator Name
Fabien LAMBIOTTE
Principal Investigator Email
lambiotte-f@ch-valenciennes.fr
Contact Person Name
Fabien LAMBIOTTE
Contact Person Email
lambiotte-f@ch-valenciennes.fr
Site Name
Centre Hospitalier Interciommunal Elbeuf, Louviers, Val de Reuil
Department Name
Anesthésie-réanimation
Principal Investigator Name
Jean Louis CHAUVET
Principal Investigator Email
jean-louis.chauvet@chi-elbeuf-louviers.fr
Contact Person Name
Jean Louis CHAUVET
Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Anesthésie-réanimation
Principal Investigator Name
Antoine DEWITTE
Principal Investigator Email
Antoine.dewitte@chu-bordeaux.fr
Contact Person Name
Antoine DEWITTE
Site Name
Hopital Ambroise Pare
Department Name
Anesthésie-réanimation
Principal Investigator Name
Antoine VIEILLARD BARON
Principal Investigator Email
antoine.vieillard-baron@aphp.fr
Contact Person Name
Antoine VIEILLARD BARON
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Anesthésie-réanimation
Principal Investigator Name
Stephane GAUDRY
Principal Investigator Email
stephane.gaudry@aphp.fr
Contact Person Name
Stephane GAUDRY
Contact Person Email
stephane.gaudry@aphp.fr
Site Name
Centre Hospitalier De Tourcoing
Department Name
Anesthésie-réanimation
Principal Investigator Name
Vanessa JEAN-MICHEL
Principal Investigator Email
vjeanmichel@ch-tourcoing.fr
Contact Person Name
Vanessa JEAN-MICHEL
Contact Person Email
vjeanmichel@ch-tourcoing.fr
Site Name
Centre Hospitalier Universitaire De Nimes
Department Name
Anesthésie-réanimation
Principal Investigator Name
Laurent MULLER
Principal Investigator Email
laurent.muller@chu-nimes.fr
Contact Person Name
Laurent MULLER
Contact Person Email
laurent.muller@chu-nimes.fr
Site Name
Centre Hospitalier Regional De Marseille
Department Name
Anesthésie-réanimation
Principal Investigator Name
Marc LEONE
Principal Investigator Email
Marc.leone@ap-hm.fr
Contact Person Name
Marc LEONE
Contact Person Email
Marc.leone@ap-hm.fr
Site Name
CHRU De Nancy
Department Name
Anesthésie-réanimation
Principal Investigator Name
Bruno LEVY
Principal Investigator Email
b.levy@chru-nancy.fr
Contact Person Name
Bruno LEVY
Contact Person Email
b.levy@chru-nancy.fr
Site Name
Hospices Civils De Lyon
Department Name
Anesthésie-réanimation
Principal Investigator Name
Bernard ALLAOUCHICHE
Principal Investigator Email
bernard.allaouchiche@chu-lyon.fr
Contact Person Name
Bernard ALLAOUCHICHE
Site Name
Centre Hospitalier De Maubeuge
Department Name
Anesthésie-réanimation
Principal Investigator Name
Mohamed BOUGUETTAYA
Principal Investigator Email
BOUGUETTAYA.Mohamed@ch-maubeuge.fr
Contact Person Name
Mohamed BOUGUETTAYA
Site Name
Union Mut Gestion Groupe Hosp Mutualiste De Grenoble
Department Name
Anesthésie-réanimation
Principal Investigator Name
Joanna BOUGNAUD
Principal Investigator Email
jbougnaud1@chu-grenoble.fr
Contact Person Name
Joanna BOUGNAUD
Contact Person Email
jbougnaud1@chu-grenoble.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Anesthésie-réanimation
Principal Investigator Name
Jean-Michel CONSTANTIN
Principal Investigator Email
jean-michel.constantin@aphp.fr
Contact Person Name
Jean-Michel CONSTANTIN
Contact Person Email
jean-michel.constantin@aphp.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Anesthésie-réanimation
Principal Investigator Name
Mehdi MARZOUK
Principal Investigator Email
mmarzouk@ch-bethune.fr
Contact Person Name
Mehdi MARZOUK
Contact Person Email
mmarzouk@ch-bethune.fr
Site Name
Chorale Du Centre Hospitalier De Lens
Department Name
Anesthésie-réanimation
Principal Investigator Name
Guillaume DEGOUY
Principal Investigator Email
gdegouy@ch-lens.fr
Contact Person Name
Guillaume DEGOUY
Contact Person Email
gdegouy@ch-lens.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Anesthésie-réanimation
Principal Investigator Name
Armand MEKONTSO DESSAP
Principal Investigator Email
armand.dessap@aphp.fr
Contact Person Name
Armand MEKONTSO DESSAP
Contact Person Email
armand.dessap@aphp.fr
Site Name
Centre Hospitalier Simone Veil De Beauvais
Department Name
Anesthésie-réanimation
Principal Investigator Name
Jack RICHECOEUR
Principal Investigator Email
j.richecoeur@ch-beauvais.fr
Contact Person Name
Jack RICHECOEUR
Contact Person Email
j.richecoeur@ch-beauvais.fr
Site Name
Centre Hospitalier Public Du Cotentin
Department Name
Anesthésie-réanimation
Principal Investigator Name
Xavier SOULOY
Principal Investigator Email
xavier.souloy@ch-cotentin.fr
Contact Person Name
Xavier SOULOY
Contact Person Email
xavier.souloy@ch-cotentin.fr
Site Name
Centre Hospitalier Dr Jean Eric Techer
Department Name
Anesthésie-réanimation
Principal Investigator Name
Joseph BAYEKULA MAFULA
Principal Investigator Email
Bayekula@ch-calais.fr
Contact Person Name
Joseph BAYEKULA MAFULA
Contact Person Email
Bayekula@ch-calais.fr
Site Name
Centre Hospitalier Universitaire De Caen Normandie
Department Name
Anesthésie-réanimation
Principal Investigator Name
Damien DU CHEYRON
Principal Investigator Email
ducheyron-d@chu-caen.fr
Contact Person Name
Damien DU CHEYRON
Contact Person Email
ducheyron-d@chu-caen.fr
Site Name
Centre Hospitalier Universitaire D Orleans
Department Name
Anesthésie-réanimation
Principal Investigator Name
Marie LIM-LEGOUGE
Principal Investigator Email
marie.lim-legouge@chr-orleans.fr
Contact Person Name
Marie LIM-LEGOUGE
Site Name
Hopital Ambroise Pare
Department Name
Anesthésie-réanimation
Principal Investigator Name
Antoine VIEILLARD BARON
Principal Investigator Email
antoine.vieillard-baron@aphp.fr
Contact Person Name
Antoine VIEILLARD BARON
Site Name
Centre Hospitalier Intercommunal Compiegne Noyon
Department Name
Anesthésie-réanimation
Principal Investigator Name
Geneviève BARJON
Principal Investigator Email
G.BARJON@ch-compiegnenoyon.fr
Contact Person Name
Geneviève BARJON
Contact Person Email
G.BARJON@ch-compiegnenoyon.fr
Site Name
Centre Hospitalier D Avignon
Department Name
Anesthésie-réanimation
Principal Investigator Name
Pierre DUCQ
Principal Investigator Email
DUCQ.Pierre@ch-avignon.fr
Contact Person Name
Pierre DUCQ
Contact Person Email
DUCQ.Pierre@ch-avignon.fr
Site Name
Centre Hospitalier Regional Et Universitaire De Brest
Department Name
Anesthésie-réanimation
Principal Investigator Name
Laetitia BODENES
Principal Investigator Email
laetitia.bodenes@chu-brest.fr
Contact Person Name
Laetitia BODENES
Contact Person Email
laetitia.bodenes@chu-brest.fr
Site Name
Centre Hospitalier De Boulogne Sur Mer
Department Name
Anesthésie-réanimation
Principal Investigator Name
Arthur SIMONNET
Principal Investigator Email
a.simonnet@ch-boulogne.fr
Contact Person Name
Arthur SIMONNET
Contact Person Email
a.simonnet@ch-boulogne.fr
Site Name
Centre Hospitalier De Roubaix
Department Name
Anesthésie-réanimation
Principal Investigator Name
Patrick HERBECQ
Principal Investigator Email
patrick.herbecq@ch-roubaix.fr
Contact Person Name
Patrick HERBECQ
Contact Person Email
patrick.herbecq@ch-roubaix.fr
Site Name
Centre Hospitalier Universitaire De Montpellier
Department Name
Anesthésie-réanimation
Principal Investigator Name
Kada KLOUCHE
Principal Investigator Email
k-klouche@chu-montpellier.fr
Contact Person Name
Kada KLOUCHE
Contact Person Email
k-klouche@chu-montpellier.fr
Site Name
Centre Hospitalier D'Arras
Department Name
Anesthésie-réanimation
Principal Investigator Name
Maxime GRANIER
Principal Investigator Email
Maxime.GRANIER@ch-arras.fr
Contact Person Name
Maxime GRANIER
Contact Person Email
Maxime.GRANIER@ch-arras.fr
Site Name
CHU Kremlin Bicêtre
Department Name
Anesthésie-réanimation
Principal Investigator Name
Nadia ANGUEL
Principal Investigator Email
nadia.anguel@aphp.fr
Contact Person Name
Nadia ANGUEL
Contact Person Email
nadia.anguel@aphp.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Intensive Care Unit
Principal Investigator Name
Fabrice UHEL
Principal Investigator Email
fabrice.uhel@aphp.fr
Contact Person Name
Fabrice UHEL
Contact Person Email
fabrice.uhel@aphp.fr
Site Name
Centre Hospitalier de Douai
Department Name
Anesthésie-réanimation
Principal Investigator Name
Philippe MOREL
Principal Investigator Email
Philippe.morel@ch-douai.fr
Contact Person Name
Philippe MOREL
Contact Person Email
Philippe.morel@ch-douai.fr
Site Name
Hospital Edouard Herriot
Department Name
Anesthésie-réanimation
Principal Investigator Name
Anne-Claire LUKASZEWICZ
Principal Investigator Email
anne-claire.lukaszewicz@chu-lyon.fr
Contact Person Name
Anne-Claire LUKASZEWICZ
Site Name
Groupement Des Hopitaux De L'Institut Catholique De Lille
Department Name
a
Principal Investigator Name
VANDERLINDEN Thierry VANDERLINDEN
Principal Investigator Email
vanderlinden.thierry@ghicl.net
Contact Person Name
VANDERLINDEN Thierry VANDERLINDEN
Contact Person Email
vanderlinden.thierry@ghicl.net
Site Name
Centre Hospitalier Universitaire De Dijon
Department Name
Anesthésie-réanimation
Principal Investigator Name
Pierre-grégoire GUINOT
Principal Investigator Email
pierregregoire.guinot@chu-dijon.fr
Contact Person Name
Pierre-grégoire GUINOT
Site Name
Centre Hospitalier De Dieppe
Department Name
Anesthésie-réanimation
Principal Investigator Name
Pierre Louis DECLERCQ
Principal Investigator Email
PDeclercq@ch-dieppe.fr
Contact Person Name
Pierre Louis DECLERCQ
Contact Person Email
PDeclercq@ch-dieppe.fr
Site Name
Centre Hospitalier Universitaire Amiens Picardie
Department Name
Anesthésie-réanimation
Principal Investigator Name
MICHEL SLAMA
Principal Investigator Email
slama.michel@chu-amiens.fr
Contact Person Name
MICHEL SLAMA
Contact Person Email
slama.michel@chu-amiens.fr

Sponsor

Primary sponsor

Full Name
Centre Hospitalier Universitaire Amiens Picardie
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
France

Investigational products

Investigational Product Name
Rapibloc 300 mg powder for solution for infusion.
Active Substance
Landiolol hydrochloride
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
Authorised (marketingAuthNumber PA1353/007/001)
Maximum Dose
8064 mg (max daily)
Investigational Product Name
CHLORURE DE SODIUM 0,9 % AGUETTANT, solution pour perfusion
Active Substance
Sodium chloride
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
Authorised (marketingAuthNumber 34009 352 291 1 3)
Maximum Dose
1344 ml (max daily)

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