Prophylactic Anti-aRrhythmic Therapy With Amiodarone in Critically Ill Patients Admitted for an Out-of-hospital Cardiac Arrest With Initial Shockable Rhythm
PARACA
1 other identifier
interventional
674
1 country
29
Brief Summary
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2025
Shorter than P25 for phase_3
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 15, 2025
CompletedFirst Posted
Study publicly available on registry
February 19, 2025
CompletedStudy Start
First participant enrolled
November 6, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 15, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 15, 2027
December 23, 2025
December 1, 2025
1.2 years
January 15, 2025
December 17, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Rate of Mortality and severe ventricular arrhythmia
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).
30 days
Secondary Outcomes (10)
outcomes related with cardiac events
90 days
outcomes related with mortality
90 days
Duration of invasive mechanical ventilation
90 days
Number of participants with outcomes related with amiodorane side effects
5 days
Neurological outcome
90 days
- +5 more secondary outcomes
Study Arms (2)
Amiodarone
EXPERIMENTALInitial 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
NO INTERVENTIONInterventions
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.
Eligibility Criteria
You may qualify if:
- Patient aged ≥ 18 years
- Admitted in intensive care unit
- Out-of-hospital cardiac arrest with initial shockable rhythm
- Presumed cardiac or unknown cause
- Delay between ROSC and screening for randomisation \< 6 hours
- Informed consent from the patient or a surrogate or deferred consent
- Affiliated to or benefiting from a social insurance
You may not qualify if:
- Cardiac arrest secondary to an extra-cardiac cause (suspected or confirmed)
- Indication for amiodarone decided by the physician at ICU admission
- No central venous catheter available for continuous infusion of amidoarone
- Thyroid disease under treatment
- History of cardiac conduction disorders, not treated by permanent pacemaker
- Any contra indication to amiodarone treatment
- Refractory ventricular arrhythmia or electrical storm
- Need for veno-arterial extracorporeal membrane oxygenation (VA-ECMO) at admission
- Known limitations in therapy and Do Not Resuscitate-order
- Moribund patient due to pre-arrest history (estimated life expectancy \< 3 months)
- Pregnant or breastfeeding women
- Patient needing a nadolol treatment due to QT long syndrome or catecholaminergic polymorphic ventricular tachycardia
- Patient with known pulmonary fibrosis
- Patient with known interstitial lung disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (29)
Chu Amiens
Amiens, France
Chu Angers
Angers, France
CH annecy genevois
Annecy, France
Ch Argenteuil
Argenteuil, France
CH Mondor
Aurillac, France
CHU Brest
Brest, France
CH Brive
Brive-la-Gaillarde, France
Chu Caen
Caen, France
Chi Nord Ardennes
Charleville-Mézières, France
CHSF
Corbeil-Essonnes, France
CHD vendée
La Roche-sur-Yon, France
CH la rochelle
La Rochelle, France
Hcl
Lyon, France
Ap Hm
Marseille, France
Hopital Cartier
Massy, France
chi Gregoire
Montreuil, France
Hoptial Mulhouse
Mulhouse, France
CHU Nantes
Nantes, France
Clinique Ambroise Paré
Neuilly-sur-Seine, France
CHU Nice -MIR Archet
Nice, France
CHU Nice -MIR Pasteur
Nice, France
Chu Orléans
Orléans, France
CHU Cochin
Paris, France
Hopital saint joseph
Paris, France
CHU Poitiers
Poitiers, France
Chu Strasbourg
Strasbourg, France
CHI Toulon
Toulon, France
Chu Toulouse
Toulouse, France
CH Cotentin
Valognes, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Investigator coordonator
Study Record Dates
First Submitted
January 15, 2025
First Posted
February 19, 2025
Study Start
November 6, 2025
Primary Completion (Estimated)
January 15, 2027
Study Completion (Estimated)
March 15, 2027
Last Updated
December 23, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share