Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT06835491

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

Complete this quick 3-step screening to check your eligibility

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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

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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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