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Recruiting NCT06835491

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

Phase III Interventional Ventricular Arrhythmias and Cardiac Arrest

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Amiodarone.
Who it may be relevant to
Registry conditions: Ventricular Arrhythmias and Cardiac Arrest. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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)

Interventions

  • 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.

Primary outcome measures

  • Rate of Mortality and severe ventricular arrhythmia [Time frame: 30 days]
Secondary outcome measures (10)
  • outcomes related with cardiac events [Time frame: 90 days]
  • outcomes related with mortality [Time frame: 90 days]
  • Duration of invasive mechanical ventilation [Time frame: 90 days]
  • Number of participants with outcomes related with amiodorane side effects [Time frame: 5 days]
  • Neurological outcome [Time frame: 90 days]
  • Duration vasopressor infusion [Time frame: 90 days]
  • Length of ICU stay [Time frame: 90 days]
  • Length of stay in hospital [Time frame: 90 days]
  • Dose of the anti-arrhythmic drugs [Time frame: 90 days]
  • Number of days of anti-arrhythmic drugs [Time frame: 90 days]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

France · 29 centers
  • Chu Amiens — Amiens
  • Chu Angers — Angers
  • CH annecy genevois — Annecy
  • Ch Argenteuil — Argenteuil
  • CH Mondor — Aurillac
  • CHU Brest — Brest
  • CH Brive — Brive-la-Gaillarde
  • Chu Caen — Caen
  • … and 21 more centers

Identifiers

NCT: NCT06835491 · P23/08_PARACA

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗