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

Recruiting Phase 3 Interventional Study
Ventricular Arrhythmias and Cardiac Arrest
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Prevention
Participants needed
674 (estimated)
Sponsor
Versailles Hospital · Other
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About This Trial
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 t…
Trial Locations
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Eligibility Criteria
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…
Contacts

Sandrine Roux

0139239777

sroux@ght78sud.fr

CONTACT