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NCT Number: NCT06835491

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)

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Chu Amiens, Amiens, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient aged ≥ 18 years
  • Admitted in intensive care unit
  • Out-of-hospital cardiac arrest with initial shockable rhythm
  • Presumed cardiac or unknown cause
  • Delay between ROSC and screening for randomisation < 6 hours
  • Informed consent from the patient or a surrogate or deferred consent
  • Affiliated to or benefiting from a social insurance

Exclusion criteria

  • Cardiac arrest secondary to an extra-cardiac cause (suspected or confirmed)
  • Indication for amiodarone decided by the physician at ICU admission
  • No central venous catheter available for continuous infusion of amidoarone
  • Thyroid disease under treatment
  • History of cardiac conduction disorders, not treated by permanent pacemaker
  • Any contra indication to amiodarone treatment
  • Refractory ventricular arrhythmia or electrical storm
  • Need for veno-arterial extracorporeal membrane oxygenation (VA-ECMO) at admission
  • Known limitations in therapy and Do Not Resuscitate-order
  • Moribund patient due to pre-arrest history (estimated life expectancy < 3 months)
  • Pregnant or breastfeeding women
  • Patient needing a nadolol treatment due to QT long syndrome or catecholaminergic polymorphic ventricular tachycardia
  • Patient with known pulmonary fibrosis
  • Patient with known interstitial lung disease

Treatment and study plan

Amiodarone

Drug

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.

Primary outcomes

  1. Rate of Mortality and severe ventricular arrhythmia

    Time frame: 30 days

    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).

Secondary outcomes

  1. outcomes related with cardiac events

    Time frame: 90 days

    • 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
  2. outcomes related with mortality

    Time frame: 90 days

    • ICU mortality
    • Hospital (and 30-day) mortality
    • Day 90 mortality
  3. Duration of invasive mechanical ventilation

    Time frame: 90 days

  4. Number of participants with outcomes related with amiodorane side effects

    Time frame: 5 days

    Number of the following side effects, patients could experimente (if applicable) during amiodarone infusion:

    • Conduction disorders
    • Hemodynamic consequences
    • Hepatic cytolysis
    • Anaphylaxis
  5. Neurological outcome

    Time frame: 90 days

    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)

  6. Duration vasopressor infusion

    Time frame: 90 days

  7. Length of ICU stay

    Time frame: 90 days

  8. Length of stay in hospital

    Time frame: 90 days

  9. Dose of the anti-arrhythmic drugs

    Time frame: 90 days

  10. Number of days of anti-arrhythmic drugs

    Time frame: 90 days

Study contacts

Contact information is provided by the study sponsor or research team.

Sandrine Roux

CONTACT

[email protected]

0139239777

Sponsors and collaborators

Lead sponsor

Versailles Hospital

Other

Registry information

Official study title

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

Acronym: PARACA

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Feb 19, 2025
Registry last updated
Dec 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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