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

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

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)

Study Overview

• Status: Recruiting
• Conditions: Ventricular Arrhythmias and Cardiac Arrest
• Intervention / Treatment: Drug: Amiodarone

• Study Type: Interventional
• Enrollment (Estimated): 674
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Sandrine Roux; Phone Number: 0139239777; Email: sroux@ght78sud.fr

Study Locations

• France
  • Amiens, France
    • Not yet recruiting
    • CHU Amiens
    • Contact: julien maizel, md
  • Angers, France
    • Recruiting
    • CHU Angers
    • Contact: pierre asfar, MD
  • Annecy, France
    • Recruiting
    • Ch Annecy Genevois
    • Contact: davis bougon, md
  • Argenteuil, France
    • Recruiting
    • CH Argenteuil
    • Contact: Gaetan Plantefeve, MD
  • Aurillac, France
    • Recruiting
    • CH Mondor
    • Contact: Emanuele turbil, MD
  • Brest, France
    • Recruiting
    • CHU Brest
    • Contact: pierre bailly, MD
  • Brive-la-Gaillarde, France
    • Recruiting
    • CH Brive
    • Contact: cédric barucchi, MD
  • Caen, France
    • Not yet recruiting
    • CHU caen
    • Contact: cédric daubin, MD
  • Charleville-Mézières, France
    • Recruiting
    • Chi Nord Ardennes
    • Contact: jérémy rosman, MD
  • Corbeil-Essonnes, France
    • Recruiting
    • CHSF
    • Contact: sophie marques, md
  • La Roche-sur-Yon, France
    • Recruiting
    • CHD Vendee
    • Contact: gwenhael colin, MD
  • La Rochelle, France
    • Recruiting
    • CH La Rochelle
    • Contact: francois perrier, MD
  • Lyon, France
    • Recruiting
    • HCL
    • Contact: jean christophe richard, MD
  • Marseille, France
    • Recruiting
    • Ap Hm
    • Contact: jeremy bourenne
  • Massy, France
    • Recruiting
    • Hopital Cartier
    • Contact: Wulfran BOUGOUIN, MD
  • Montreuil, France
    • Not yet recruiting
    • chi Gregoire
    • Contact: vincent das, MD
  • Mulhouse, France
    • Recruiting
    • Hoptial Mulhouse
    • Contact: guylaine labro, md
  • Nantes, France
    • Not yet recruiting
    • CHU Nantes
    • Contact: jean baptiste lascarrou, MD
  • Neuilly-sur-Seine, France
    • Recruiting
    • Clinique Ambroise Pare
    • Contact: Guillaume GERI, MD
  • Nice, France
    • Recruiting
    • CHU Nice -MIR Archet
    • Contact: mathieu jozwiak
  • Nice, France
    • Recruiting
    • CHU Nice -MIR Pasteur
    • Contact: denis doyen, MD
  • Orléans, France
    • Recruiting
    • CHU Orléans
    • Contact: grégoire muller, MD
  • Paris, France
    • Recruiting
    • CHU Cochin
    • Contact: alain coriou, MD
  • Paris, France
    • Recruiting
    • Hopital Saint Joseph
    • Contact: cedric bruel, MD
  • Poitiers, France
    • Recruiting
    • CHU Poitiers
    • Contact: florence boissier, MD
  • Strasbourg, France
    • Recruiting
    • CHU Strasbourg
    • Contact: antoine studer, md
  • Toulon, France
    • Recruiting
    • CHI Toulon
    • Contact: noemie peres, MD
  • Toulouse, France
    • Recruiting
    • CHU Toulouse
    • Contact: Clément DELMAS, MD
  • Valognes, France
    • Recruiting
    • CH Cotentin
    • Contact: julien calus, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
Experimental: Amiodarone; 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.	Drug: Amiodarone; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Mortality and severe ventricular arrhythmia	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).	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of stay in hospital		90 days
Length of ICU stay		90 days
outcomes related with cardiac events	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	90 days
outcomes related with mortality	ICU mortality; Hospital (and 30-day) mortality; Day 90 mortality	90 days
Duration of invasive mechanical ventilation		90 days
Number of participants with outcomes related with amiodorane side effects	Number of the following side effects, patients could experimente (if applicable) during amiodarone infusion: Conduction disorders; Hemodynamic consequences; Hepatic cytolysis; Anaphylaxis	5 days
Neurological outcome	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)	90 days
Duration vasopressor infusion		90 days
Dose of the anti-arrhythmic drugs		90 days
Number of days of anti-arrhythmic drugs		90 days

Collaborators and Investigators

• Sponsor: Versailles Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2025
• Primary Completion (Estimated): January 15, 2027
• Study Completion (Estimated): March 15, 2027

Study Registration Dates

• First Submitted: January 15, 2025
• First Submitted That Met QC Criteria: February 17, 2025
• First Posted (Actual): February 19, 2025

Study Record Updates

• Last Update Posted (Actual): December 23, 2025
• Last Update Submitted That Met QC Criteria: December 17, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Arrest; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Benzofurans; Amiodarone
• Other Study ID Numbers: P23/08_PARACA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No