Preventive amiodarone after out-of-hospital cardiac arrest with an initial shockable rhythm

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Chu Angers
  Angers, France Recruiting
• CH annecy genevois
  Annecy, France Recruiting
• Ch Argenteuil
  Argenteuil, France Recruiting
• CH Mondor
  Aurillac, France Recruiting
• CHU Brest
  Brest, France Recruiting
• CH Brive
  Brive-la-Gaillarde, France Recruiting

Study contacts

• Study coordinator: Sandrine Roux
• Email: sroux@ght78sud.fr
• Phone: 0139239777

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Predicting high-risk arrhythmic events in people with arrhythmic mitral valve prolapse

  This study tests a risk model to see which patients with arrhythmic mitral valve prolapse might need an ICD.

  Recruiting Oslo University Hospital · Oslo · NCT07830888

• Monitoring heart rhythms in patients starting BTK inhibitors

  This study is testing how well a heart monitor can detect new heart rhythm problems in patients starting treatment with BTK inhibitors.

  Recruiting Northwell Health · New Hyde Park, New York · NCT05643235

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.