Clinical trial • Not applicable • Cardiology

AMIODARONE HYDROCHLORIDE for Out-of-hospital cardiac arrest (initial shockable rhythm)

Not applicable trial of AMIODARONE HYDROCHLORIDE for Out-of-hospital cardiac arrest (initial shockable rhythm). Randomised. 674 participants.

Overview

Trial Therapeutic Area
Cardiology
Trial Disease
Out-of-hospital cardiac arrest (initial shockable rhythm)
Trial Stage
Not applicable
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
20-06-2024
First CTIS Authorization Date
22-01-2025

Trial design

Randomised Not applicable trial across 28 sites in France.

Randomised
Yes
Target Sample Size
674
Trial Duration For Participant
30

Eligibility

Recruits 674 The trial includes vulnerable critically ill ICU patients; informed consent may be obtained from the patient, from a surrogate, or via deferred consent (inclusion in emergency situations)..

Pregnancy Exclusion
Pregnant or breastfeeding women
Vulnerable Population
The trial includes vulnerable critically ill ICU patients; informed consent may be obtained from the patient, from a surrogate, or via deferred consent (inclusion in emergency situations).

Inclusion criteria

  • {"criterion_text":"- Patient aged ≥ 18 years\n- Admitted in intensive care unit\n- Out-of-hospital cardiac arrest with initial shockable rhythm\n- Presumed cardiac or unknown cause\n- Delay between ROSC and screening for randomisation < 6 hours\n- Informed consent from the patient or a surrogate or deferred consent\n- Affiliated to or benefiting from a social insurance"}

Exclusion criteria

  • {"criterion_text":"- Cardiac arrest secondary to an extra-cardiac cause (suspected or confirmed)\n- Moribund patient due to pre-arrest history (estimated life expectancy < 3 months)\n- Pregnant or breastfeeding women\n- Indication for amiodarone decided by the physician at ICU admission\n- No central venous catheter available for continuous infusion of amiodarone\n- History of thyroid disease (except for stable, uncomplicated hypothyroidism)\n- History of cardiac conduction disorders, not treated by permanent pacemaker\n- Amiodarone allergy\n- Refractory ventricular arrhythmia or electrical storm\n- Need for veno-arterial extracorporeal membrane oxygenation (VA-ECMO) at admission\n- Known limitations in therapy and Do Not Resuscitate-order"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- The primary endpoint is a composite of 30-day (starting from inclusion) all-cause mortality and occurrence of severe in-hospital ventricular arrhythmia, defined by ventricular fibrillation and/or ventricular tachycardia requiring intervention occurring between inclusion and hospital discharge (or 30-day whichever the sooner).","definition_or_measurement_approach":"Composite of 30-day all-cause mortality and severe in-hospital ventricular arrhythmia; severe arrhythmia defined as ventricular fibrillation and/or ventricular tachycardia requiring intervention occurring between inclusion and hospital discharge (or 30 days whichever is sooner)."}

Recruitment

Planned Sample Size
674
Recruitment Window Months
27
Consent Approach
Informed consent obtained from the patient, or from a surrogate, or via deferred consent in emergency situations; subject information and informed consent form documents available (multiple versions), with translations/versions including French.

Geography

Total Number Of Sites
28
Total Number Of Participants
674

France

Latest Decision Or Authorization Date
22-01-2025
Number Of Sites
28
Number Of Participants
674

Sites

Site Name
Centre Hospitalier de Charleville-Mézières
Department Name
Réanimation
Contact Person Name
Jérémy Rosman
Contact Person Email
jeremy.rosman.ght.na@gmail.com
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Réanimation
Contact Person Name
Alain Cariou
Contact Person Email
alain.cariou@aphp.fr
Site Name
Centre Hospitalier Universitaire De Nice
Department Name
Réanimation
Contact Person Name
Denis Doyen
Contact Person Email
doyen.d@chu-nice.fr
Site Name
Centre Hospitalier Universitaire De Caen Normandie
Department Name
Réanimation
Contact Person Name
Cédric Daubin
Contact Person Email
daubin-c@chu-caen.fr
Site Name
Centre Hospitalier Universitaire De Poitiers
Department Name
Réanimation
Contact Person Name
Florence Boissier
Site Name
Centre Hospitalier De Versailles
Department Name
Réanimation
Contact Person Name
Hugo Bellut
Contact Person Email
hbellut@ght78sud.fr
Site Name
Centre Medico Chirurgical Ambroise Pare Hartmann
Department Name
Réanimation
Contact Person Name
Guillaume Geri
Contact Person Email
ggeri92@gmail.com
Site Name
Centre Hospitalier Universitaire Amiens Picardie
Department Name
Réanimation
Contact Person Name
Julien Maizel
Contact Person Email
Maizel.Julien@chu-amiens.fr
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
Réanimation
Contact Person Name
Clément Delmas
Contact Person Email
delmas.clement@chu-toulouse.fr
Site Name
Centre Hospitalier Universitaire De Nice
Department Name
Réanimation
Contact Person Name
Mathieu Jozwiak
Contact Person Email
jozwiak.m@chu-nice.fr
Site Name
Centre Hospitalier Henri Mondor d'Aurillac
Department Name
Réanimation
Contact Person Name
Emanuele Turbil
Contact Person Email
emanuele.turbil@gmail.com
Site Name
Centre Hospitalier Intercommunal Toulon / La Seine-Sur-Mer
Department Name
Réanimation
Contact Person Name
Noemie Peres
Contact Person Email
Noemie.Peres@ch-toulon.fr
Site Name
Centre Hospitalier Victor Dupouy Argenteuil
Department Name
Réanimation
Contact Person Name
Gaetan Plantefeve
Site Name
Centre Hospitalier Regional Et Universitaire De Brest
Department Name
Réanimation
Contact Person Name
Pierre Bailly
Contact Person Email
pierre.bailly@chu-brest.fr
Site Name
Centre Hospitalier Departemental Vendee
Department Name
Réanimation
Contact Person Name
Gwenhael Colin
Contact Person Email
gwenhael.colin@ght85.fr
Site Name
Centre Hospitalier Annecy Genevois
Department Name
Réanimation
Contact Person Name
David Bougon
Contact Person Email
dbougon@ch-annecygenevois.fr
Site Name
Centre Hospitalier Universitaire D Orleans
Department Name
Réanimation
Contact Person Name
Grégoire Muller
Contact Person Email
gregoire.muller@chr-orleans.fr
Site Name
Les Hopitaux Universitaires De Strasbourg
Department Name
Réanimation
Contact Person Name
Antoine Studer
Site Name
Centre Hospitalier Sud Francilien
Department Name
Réanimation
Contact Person Name
Sophie Marque
Contact Person Email
sophie.marque@chsf.fr
Site Name
Hospices Civils De Lyon
Department Name
Réanimation
Contact Person Name
Jean-Christophe Richard
Site Name
Groupe Hospitalier De La Region De Mulhouse Et Sud Alsace
Department Name
Réanimation
Contact Person Name
Guylaine Labro
Contact Person Email
guylaine.labro@ghrmsa.fr
Site Name
Centre Hospitalier Regional De Marseille
Department Name
Réanimation
Contact Person Name
Jérémy Bourenne
Contact Person Email
Jeremy.BOURENNE@ap-hm.fr
Site Name
Centre hospitalier de Brive
Department Name
Réanimation
Contact Person Name
Cédric Barucchi
Contact Person Email
cedric.barucchi@ch-brive.fr
Site Name
GIE Groupe hospitalier Paris Saint-Joseph/Vinci
Department Name
Réanimation
Contact Person Name
Cédric Bruel
Contact Person Email
cbruel@ghps.fr
Site Name
Centre Hospitalier Groupe Hospitalier De La Rochelle Re Aunis
Department Name
Réanimation
Contact Person Name
Francois Perier
Site Name
Centre Hospitalier Public Du Cotentin
Department Name
Réanimation
Contact Person Name
Julien Calus
Contact Person Email
julien.calus@ch-cotentin.fr
Site Name
Hopital Prive Jacques Cartier
Department Name
Réanimation
Contact Person Name
Wulfran Bougouin
Contact Person Email
wulfran.bougouin@gmail.com
Site Name
Centre Hospitalier Universitaire D'Angers
Department Name
Réanimation
Contact Person Name
Pierre Asfar
Contact Person Email
PiAsfar@chu-angers.fr

Sponsor

Primary sponsor

Full Name
Centre Hospitalier De Versailles
Organisation Type
Hospital/Clinic/Other health care facility
Country Of Registered Address
France

Investigational products

Investigational Product Name
CORDARONE 150 mg/3 ml, solution injectable en ampoule (IV)
Active Substance
AMIODARONE HYDROCHLORIDE
Modality
Small molecule
Routes Of Administration
INTRAVENOUS BOLUS INJECTION/IV INFUSION
Route
INTRAVENOUS BOLUS INJECTION/IV INFUSION
Authorisation Status
Authorised in France (marketing authorisation number 34009 319 997 6 8; MAH: SANOFI WINTHROP INDUSTRIE)
Maximum Dose
Max daily dose 900 mg; max total dose 2700 mg

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