Ventricular Arrhythmias and Cardiac Arrest
Conditions
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)
Interventions
DRUGAmiodarone
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.
Sponsors
Versailles Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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 |
| 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 | — |
| Duration vasopressor infusion | 90 days | — |
Countries
France
Contacts
Primary ContactSandrine Roux
Outcome results
None listed