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

RecruitingPhase 3Ages 18 Years - anyAllVersailles Hospital
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In plain words

What the trial is, and whether it could suit you

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)

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Patient aged โ‰ฅ 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
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What it tests

  • Amiodarone
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Where

29 sites
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

โ€ฆand 21 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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