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RECRUITING
NCT06835491
PHASE3

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

View on ClinicalTrials.gov

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)

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

674

Start Date

2025-11-06

Completion Date

2027-03-15

Last Updated

2025-12-23

Healthy Volunteers

No

Interventions

DRUG

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.

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