Health TrialsbyHealthPanel

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

ConditionVentricular Arrhythmias and Cardiac Arrest
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorVersailles Hospital

About this trial

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)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient aged ≥ 18 years

Admitted in intensive care unit

Out-of-hospital cardiac arrest with initial shockable rhythm

Presumed cardiac or unknown cause

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

674 Participants
are divided into 2 treatment groups
Group A: AmiodaroneExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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).

Time frame
30 days

Secondary outcomes

1

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

Time frame
90 days
2

outcomes related with mortality

* ICU mortality * Hospital (and 30-day) mortality * Day 90 mortality

Time frame
90 days
3

Duration of invasive mechanical ventilation

Time frame
90 days
4

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

Time frame
5 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Versailles Hospital

Lead sponsor

Source ClinicalTrials.gov
Apply now