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

Launched by VERSAILLES HOSPITAL · Feb 17, 2025

Keywords

ClinConnect Summary

This clinical trial is studying whether a medication called amiodarone can help prevent serious heart rhythm problems and improve survival rates in critically ill patients who have experienced a cardiac arrest outside of the hospital and had an initial shockable heart rhythm. The goal is to see if giving amiodarone for 72 hours can lower the chances of patients dying or having dangerous heart rhythms that need emergency treatment within 30 days of being admitted to the hospital.

To be eligible for this trial, patients must be at least 18 years old, have been admitted to an intensive care unit after a cardiac arrest with a shockable rhythm, and have a suspected heart-related cause for their cardiac arrest. The trial is not open for recruitment yet, but those who participate will need to provide informed consent, either directly or through a family member. It’s important to note that certain patients, such as those with specific heart conditions or other serious health issues, may not be eligible to join the study. If you or a loved one are considering participation, please discuss it with the healthcare team for more information.

Gender

ALL

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