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NCT06835491 | NOT YET RECRUITING | Ventricular Arrhythmias and Cardiac Arrest

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

Versailles Hospital

Information provided by (Responsible Party):

Hugo Bellut

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)

Condition or disease

Ventricular Arrhythmias and Cardiac Arrest

Intervention/treatment

Amiodarone

Phase

PHASE3

Study Type : INTERVENTIONAL
Estimated Enrollment : 674 participants
Masking : NONE
Primary Purpose : PREVENTION
Official Title : Prophylactic Anti-aRrhythmic Therapy with Amiodarone in Critically Ill Patients Admitted for an Out-of-hospital Cardiac Arrest with Initial Shockable Rhythm.
Actual Study Start Date : 2025-06-15
Estimated Primary Completion Date : 2027-01-15
Estimated Study Completion Date : 2027-03-15

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
Prophylactic Anti-aRrhythmic Therapy with Amiodarone in Critically Ill Patients Admitted for an Out-of-hospital Cardiac Arrest with Initial Shockable Rhythm

Location Details

NCT06835491

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

France,

Chu Amiens

Amiens, France,

Not yet recruiting

France,

Chu Angers

Angers, France,

Not yet recruiting

France,

CH Annecy Genevois

Annecy, France,

Not yet recruiting

France,

CH Argenteuil

Argenteuil, France,

Not yet recruiting

France,

CH Mondor

Aurillac, France,

Not yet recruiting

France,

CHU Brest

Brest, France,

Not yet recruiting

France,

CH Brive

Brive-la-Gaillarde, France,

Not yet recruiting

France,

Chu caes

Caen, France,

Not yet recruiting

France,

Chi Nord Ardennes

Charleville-Mézières, France,

Not yet recruiting

France,

CHSF

Corbeil-Essonnes, France,

Not yet recruiting

France,

CHD Vendée

La Roche-over-a, France,

Not yet recruiting

France,

CH La Rochelle

La Rochelle, France,

Not yet recruiting

France,

Hcl

Lyon, France,

Not yet recruiting

France,

you we

Marseille, France,

Not yet recruiting

France,

Cartier hospital

Massy, France,

Not yet recruiting

France,

who Gregoire

Montreuil, France,

Not yet recruiting

France,

Mulhouse hospital

Mulhouse, France,

Not yet recruiting

France,

Chu nantes

Nantes, France,

Not yet recruiting

France,

Ambroise Paré clinic

Neuilly-sur-Seine, France,

Not yet recruiting

France,

Chu nice -mir arnet

Nice, France,

Not yet recruiting

France,

Chu nice -mir pasteur

Nice, France,

Not yet recruiting

France,

Chu Orl

Orléans, France,

Not yet recruiting

France,

CHU Cochin

Paris, France,

Not yet recruiting

France,

Hospital Saint Joseph

Paris, France,

Not yet recruiting

France,

CHU Poitiers

Poitiers, France,

Not yet recruiting

France,

Chu Strasbourg

Strasbourg, France,

Not yet recruiting

France,

Chi Toulon

Toulon, France,

Not yet recruiting

France,

He was shaking

Toulouse, France,

Not yet recruiting

France,

CH Cotentin

Valognes, France,