RecruitingPhase 3NCT06835491

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

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


Sponsor

Versailles Hospital

Enrollment

674 participants

Start Date

Nov 6, 2025

Study Type

INTERVENTIONAL

Conditions

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)


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Amiodarone for people with ventricular arrhythmias and cardiac arrest. The study is currently recruiting participants at 29 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAmiodarone

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.


Locations(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

View Full Details on ClinicalTrials.gov

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NCT06835491


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