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Preventive amiodarone after out-of-hospital cardiac arrest with an 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.

PHASE3 · Versailles Hospital · NCT06835491

This will try whether giving amiodarone for 72 hours to adults admitted to intensive care after an out-of-hospital cardiac arrest with a shockable rhythm reduces death or severe ventricular arrhythmia within 30 days.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment674 (estimated)
Ages18 Years and up
SexAll
SponsorVersailles Hospital (other)
Locations29 sites (Amiens and 28 other locations)
Trial IDNCT06835491 on ClinicalTrials.gov

What this trial studies

This Phase 3 interventional trial tests prophylactic intravenous amiodarone infusion for 72 hours in critically ill adults admitted to the ICU after an out-of-hospital cardiac arrest with an initial shockable rhythm and a presumed or unknown cardiac cause. The main outcome is a composite of 30-day all-cause mortality and/or severe in-hospital recurrence of ventricular fibrillation or ventricular tachycardia requiring intervention. Eligible patients must be screened and randomized within 6 hours of return of spontaneous circulation and have central venous access for continuous infusion. Key exclusions include extra-cardiac cause of arrest, existing indications or contraindications to amiodarone, need for VA-ECMO at admission, thyroid disease under treatment, and untreated conduction disorders.

Who should consider this trial

Good fit: Adults (≥18 years) admitted to ICU after an out-of-hospital cardiac arrest with an initial shockable rhythm, presumed or unknown cardiac cause, able to be screened within 6 hours of ROSC and with central venous access are ideal candidates.

Not a fit: Patients with a clear non-cardiac cause of arrest, those already requiring VA-ECMO, those with contraindications to amiodarone, or with preexisting indications for amiodarone are unlikely to benefit from the prophylactic approach.

Why it matters

Potential benefit: If successful, the approach could reduce early deaths and serious ventricular arrhythmia recurrences after out-of-hospital cardiac arrest.

How similar studies have performed: Amiodarone is established for treating ventricular arrhythmias during resuscitation, but prophylactic post-resuscitation use to prevent recurrence has limited large randomized Phase 3 evidence.

Eligibility criteria

Show full inclusion / exclusion 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 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

Where this trial is running

Amiens and 28 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Ventricular Arrhythmias and Cardiac Arrest

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.