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Prophylactic Anti-aRrhythmic Therapy With Amiodarone in Critically Ill Patients Admitted for an Out-of-hospital Cardiac Arrest With Initial Shockable Rhythm

NCT ID: NCT06835491

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

674 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-06

Study Completion Date

2027-03-15

Brief Summary

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To determine if prophylactic administration of amiodarone for 72 hours in critically ill patients admitted after an OHCA with shockable rhythm, with a confirmed or a presumed cardiac cause, decreases the incidence of a composite endpoint of 30-day (starting from inclusion) all-cause mortality and/or severe in-hospital ventricular arrhythmia recurrence (ventricular fibrillation and/or ventricular tachycardia requiring intervention including re-arrest)

Detailed Description

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Conditions

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Ventricular Arrhythmias and Cardiac Arrest

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Amiodarone

Initial loading dose of 300mg over 30 minutes in 250ml of glucose 5% solution. Continuous amiodarone infusion will be administered for 72 hours at a dose of 10 mg/kg without exceeding 900 mg/24h.

Group Type EXPERIMENTAL

Amiodarone

Intervention Type DRUG

Initial loading dose of 300mg over 30 minutes in 250ml of glucose 5% solution. Continuous amiodarone infusion will be administered for 72 hours at a dose of 10 mg/kg without exceeding 900 mg/24h.

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Amiodarone

Initial loading dose of 300mg over 30 minutes in 250ml of glucose 5% solution. Continuous amiodarone infusion will be administered for 72 hours at a dose of 10 mg/kg without exceeding 900 mg/24h.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Patient aged ≥ 18 years
2. Admitted in intensive care unit
3. Out-of-hospital cardiac arrest with initial shockable rhythm
4. Presumed cardiac or unknown cause
5. Delay between ROSC and screening for randomisation \< 6 hours
6. Informed consent from the patient or a surrogate or deferred consent
7. Affiliated to or benefiting from a social insurance

Exclusion Criteria

1. Cardiac arrest secondary to an extra-cardiac cause (suspected or confirmed)
2. Indication for amiodarone decided by the physician at ICU admission
3. No central venous catheter available for continuous infusion of amidoarone
4. Thyroid disease under treatment
5. History of cardiac conduction disorders, not treated by permanent pacemaker
6. Any contra indication to amiodarone treatment
7. Refractory ventricular arrhythmia or electrical storm
8. Need for veno-arterial extracorporeal membrane oxygenation (VA-ECMO) at admission
9. Known limitations in therapy and Do Not Resuscitate-order
10. Moribund patient due to pre-arrest history (estimated life expectancy \< 3 months)
11. Pregnant or breastfeeding women
12. Patient needing a nadolol treatment due to QT long syndrome or catecholaminergic polymorphic ventricular tachycardia
13. Patient with known pulmonary fibrosis
14. Patient with known interstitial lung disease
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Versailles Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hugo Bellut

Investigator coordonator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Chu Amiens

Amiens, , France

Site Status NOT_YET_RECRUITING

Chu Angers

Angers, , France

Site Status RECRUITING

CH annecy genevois

Annecy, , France

Site Status RECRUITING

Ch Argenteuil

Argenteuil, , France

Site Status RECRUITING

CH Mondor

Aurillac, , France

Site Status RECRUITING

CHU Brest

Brest, , France

Site Status RECRUITING

CH Brive

Brive-la-Gaillarde, , France

Site Status RECRUITING

Chu Caen

Caen, , France

Site Status NOT_YET_RECRUITING

Chi Nord Ardennes

Charleville-Mézières, , France

Site Status RECRUITING

CHSF

Corbeil-Essonnes, , France

Site Status RECRUITING

CHD vendée

La Roche-sur-Yon, , France

Site Status RECRUITING

CH la rochelle

La Rochelle, , France

Site Status RECRUITING

Hcl

Lyon, , France

Site Status RECRUITING

Ap Hm

Marseille, , France

Site Status RECRUITING

Hopital Cartier

Massy, , France

Site Status RECRUITING

chi Gregoire

Montreuil, , France

Site Status NOT_YET_RECRUITING

Hoptial Mulhouse

Mulhouse, , France

Site Status RECRUITING

CHU Nantes

Nantes, , France

Site Status NOT_YET_RECRUITING

Clinique Ambroise Paré

Neuilly-sur-Seine, , France

Site Status RECRUITING

CHU Nice -MIR Archet

Nice, , France

Site Status RECRUITING

CHU Nice -MIR Pasteur

Nice, , France

Site Status RECRUITING

Chu Orléans

Orléans, , France

Site Status RECRUITING

CHU Cochin

Paris, , France

Site Status RECRUITING

Hopital saint joseph

Paris, , France

Site Status RECRUITING

CHU Poitiers

Poitiers, , France

Site Status RECRUITING

Chu Strasbourg

Strasbourg, , France

Site Status RECRUITING

CHI Toulon

Toulon, , France

Site Status RECRUITING

Chu Toulouse

Toulouse, , France

Site Status RECRUITING

CH Cotentin

Valognes, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Sandrine Roux

Role: CONTACT

Phone: 0139239777

Email: [email protected]

Facility Contacts

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julien maizel, md

Role: primary

pierre asfar, MD

Role: primary

davis bougon, md

Role: primary

gaetan plantefeve, md

Role: primary

Emanuele turbil, MD

Role: primary

pierre bailly, MD

Role: primary

cédric barucchi, MD

Role: primary

cédric daubin, MD

Role: primary

jérémy rosman, MD

Role: primary

sophie marques, md

Role: primary

gwenhael colin, MD

Role: primary

francois perrier, MD

Role: primary

jean christophe richard, MD

Role: primary

jeremy bourenne

Role: primary

wulfran bougouin, md

Role: primary

vincent das, MD

Role: primary

guylaine labro, md

Role: primary

jean baptiste lascarrou, MD

Role: primary

guillaume geri, md

Role: primary

mathieu jozwiak

Role: primary

denis doyen, MD

Role: primary

grégoire muller, MD

Role: primary

alain coriou, MD

Role: primary

cedric bruel, MD

Role: primary

florence boissier, MD

Role: primary

antoine studer, md

Role: primary

noemie peres, MD

Role: primary

clement delmas, md

Role: primary

julien calus, MD

Role: primary

Other Identifiers

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P23/08_PARACA

Identifier Type: -

Identifier Source: org_study_id