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

Phase 3

Not yet recruiting

• Conditions: Ventricular Arrhythmias and Cardiac Arrest
• Interventions: Drug: Amiodarone

• Registration Number: NCT06835491
• Lead Sponsor: Versailles Hospital

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 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 tachycardia requiring intervention including re-arrest)

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study First Submitted: 2025-01-15
• Study First Submitted QC: 2025-02-17
• Last Update Submitted: 2025-02-17
• Study First Posted: 2025-02-19
• Last Update Posted: 2025-02-19
• Study Start: 2025-06-15
• Primary Completion: 2027-01-15
• Study Completion: 2027-03-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 674

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Amiodarone	Amiodarone	Initial loading dose of 300mg over 30 minutes in 250ml of glucose 5% solution. Continuous amiodarone infusion will be administered for 72 hours at a dose of 10 mg/kg without exceeding 900 mg/24h.

Primary Outcome Measures

Name	Time	Method
Rate of Mortality and severe ventricular arrhythmia	30 days	The primary endpoint is a composite of 30-day (starting from inclusion) all-cause mortality and occurrence of severe in-hospital ventricular arrhythmia, defined by ventricular fibrillation and/or ventricular tachycardia requiring intervention occurring between inclusion and hospital discharge (or 30-day whichever the sooner).

Secondary Outcome Measures

Name	Time	Method
outcomes related with cardiac events	90 days	* Occurrence of ventricular fibrillation (VF); * Occurrence of ventricular tachycardia (VT) requiring or not intervention; * Occurrence of atrial fibrillation (AF) and supraventricular tachycardia; * Occurrence of cardiac re-arrest due to asystole
outcomes related with mortality	90 days	* ICU mortality; * Hospital (and 30-day) mortality; * Day 90 mortality
Duration of invasive mechanical ventilation	90 days
Number of participants with outcomes related with amiodorane side effects	5 days	Number of the following side effects, patients could experimente (if applicable) during amiodarone infusion: * Conduction disorders; * Hemodynamic consequences; * Hepatic cytolysis; * Anaphylaxis
Neurological outcome	90 days	M-Rankin scale (the lowest score is no handicap and the highest score is death) and Glasgow Outcome Score (the lowest score is the most severe coma)
Duration vasopressor infusion	90 days
Length of ICU stay	90 days
Length of stay in hospital	90 days
Dose of the anti-arrhythmic drugs	90 days
Number of days of anti-arrhythmic drugs	90 days

Trial Locations

Locations (29)

Chu Amiens; 🇫🇷 Amiens, France

Chu Angers; 🇫🇷 Angers, France

CH annecy genevois; 🇫🇷 Annecy, France

Ch Argenteuil; 🇫🇷 Argenteuil, France

CH Mondor; 🇫🇷 Aurillac, France

CHU Brest; 🇫🇷 Brest, France

CH Brive; 🇫🇷 Brive-la-Gaillarde, France

Chu Caen; 🇫🇷 Caen, France

CHSF; 🇫🇷 Corbeil-Essonnes, France

Chi Nord Ardennes; 🇫🇷 Charleville-Mézières, France

CHD vendée; 🇫🇷 La Roche-sur-Yon, France

Clinique Ambroise Paré; 🇫🇷 Neuilly-sur-Seine, France

CH la rochelle; 🇫🇷 La Rochelle, France

Hcl; 🇫🇷 Lyon, France

Hopital Cartier; 🇫🇷 Massy, France

CHU Nantes; 🇫🇷 Nantes, France

CHU Nice -MIR Archet; 🇫🇷 Nice, France

Chu Orléans; 🇫🇷 Orléans, France

CHU Cochin; 🇫🇷 Paris, France

CHU Poitiers; 🇫🇷 Poitiers, France

CHI Toulon; 🇫🇷 Toulon, France

Ap Hm; 🇫🇷 Marseille, France

chi Gregoire; 🇫🇷 Montreuil, France

Hoptial Mulhouse; 🇫🇷 Mulhouse, France

Hopital saint joseph; 🇫🇷 Paris, France

Chu Strasbourg; 🇫🇷 Strasbourg, France

Chu Toulouse; 🇫🇷 Toulouse, France

CHU Nice -MIR Pasteur; 🇫🇷 Nice, France

CH Cotentin; 🇫🇷 Valognes, France