Actively Recruiting
Prophylactic Anti-aRrhythmic Therapy With Amiodarone in Critically Ill Patients Admitted for an Out-of-hospital Cardiac Arrest With Initial Shockable Rhythm
Led by Versailles Hospital · Updated on 2025-12-23
674
Participants Needed
29
Research Sites
70 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
Prophylactic Anti-aRrhythmic Therapy With Amiodarone in Critically Ill Patients Admitted for an Out-of-hospital Cardiac Arrest With Initial Shockable Rhythm
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient aged 18 years or older
- Admitted in intensive care unit
- Out-of-hospital cardiac arrest with initial shockable rhythm
- Presumed cardiac or unknown cause of arrest
- Delay between return of spontaneous circulation and screening for randomisation less than 6 hours
- Informed consent from the patient or a surrogate or deferred consent
- Affiliated to or benefiting from a social insurance
You will not qualify if you...
- Cardiac arrest caused by an extra-cardiac reason (suspected or confirmed)
- Physician decided amiodarone treatment at ICU admission
- No central venous catheter available for continuous amiodarone infusion
- Thyroid disease under treatment
- History of cardiac conduction disorders without permanent pacemaker treatment
- Any contraindication to amiodarone treatment
- Refractory ventricular arrhythmia or electrical storm
- Need for veno-arterial extracorporeal membrane oxygenation (VA-ECMO) at admission
- Known treatment limitations and Do Not Resuscitate order
- Moribund patient with estimated life expectancy less than 3 months due to pre-arrest history
- Pregnant or breastfeeding women
- Need for nadolol treatment due to QT long syndrome or catecholaminergic polymorphic ventricular tachycardia
- Known pulmonary fibrosis
- Known interstitial lung disease
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 29 locations
1
Chu Amiens
Amiens, France
Not Yet Recruiting
2
Chu Angers
Angers, France
Actively Recruiting
3
CH annecy genevois
Annecy, France
Actively Recruiting
4
Ch Argenteuil
Argenteuil, France
Actively Recruiting
5
CH Mondor
Aurillac, France
Actively Recruiting
6
CHU Brest
Brest, France
Actively Recruiting
7
CH Brive
Brive-la-Gaillarde, France
Actively Recruiting
8
Chu Caen
Caen, France
Not Yet Recruiting
9
Chi Nord Ardennes
Charleville-Mézières, France
Actively Recruiting
10
CHSF
Corbeil-Essonnes, France
Actively Recruiting
11
CHD vendée
La Roche-sur-Yon, France
Actively Recruiting
12
CH la rochelle
La Rochelle, France
Actively Recruiting
13
Hcl
Lyon, France
Actively Recruiting
14
Ap Hm
Marseille, France
Actively Recruiting
15
Hopital Cartier
Massy, France
Actively Recruiting
16
chi Gregoire
Montreuil, France
Not Yet Recruiting
17
Hoptial Mulhouse
Mulhouse, France
Actively Recruiting
18
CHU Nantes
Nantes, France
Not Yet Recruiting
19
Clinique Ambroise Paré
Neuilly-sur-Seine, France
Actively Recruiting
20
CHU Nice -MIR Archet
Nice, France
Actively Recruiting
21
CHU Nice -MIR Pasteur
Nice, France
Actively Recruiting
22
Chu Orléans
Orléans, France
Actively Recruiting
23
CHU Cochin
Paris, France
Actively Recruiting
24
Hopital saint joseph
Paris, France
Actively Recruiting
25
CHU Poitiers
Poitiers, France
Actively Recruiting
26
Chu Strasbourg
Strasbourg, France
Actively Recruiting
27
CHI Toulon
Toulon, France
Actively Recruiting
28
Chu Toulouse
Toulouse, France
Actively Recruiting
29
CH Cotentin
Valognes, France
Actively Recruiting
Research Team
S
Sandrine Roux
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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