Status:

RECRUITING

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

Lead Sponsor:

Versailles Hospital

Conditions:

Ventricular Arrhythmias and Cardiac Arrest

Eligibility:

All Genders

18+ years

Phase:

PHASE3

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 ...

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 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

Key Trial Info

Start Date :

November 6 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

March 15 2027

Estimated Enrollment :

674 Patients enrolled

Trial Details

Trial ID

NCT06835491

Start Date

November 6 2025

End Date

March 15 2027

Last Update

December 23 2025

Active Locations (29)

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Page 1 of 8 (29 locations)

1

Chu Amiens

Amiens, France

2

Chu Angers

Angers, France

3

CH annecy genevois

Annecy, France

4

Ch Argenteuil

Argenteuil, France

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