Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Recruiting

Study on Amiodarone for Critically Ill Patients After Out-of-Hospital Cardiac Arrest with Shockable Rhythm

Verified siteRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a medication called amiodarone in patients who have experienced an out-of-hospital cardiac arrest with an initial shockable rhythm. A cardiac arrest is a serious condition where the heart suddenly stops beating, and a shockable rhythm refers to a type of heart rhythm that can potentially be treated with an electric shock. The purpose of the study is to determine if giving amiodarone to these critically ill patients for 72 hours can reduce the chances of death or severe heart rhythm problems within 30 days.

Participants in the study will receive either amiodarone or a placebo through an intravenous injection, which means the medication is given directly into a vein. The study will monitor the patients for any severe heart rhythm issues, such as ventricular fibrillation or ventricular tachycardia, which are types of irregular heartbeats that can be life-threatening and may require medical intervention. The study aims to see if amiodarone can help prevent these problems from occurring again after the initial cardiac arrest.

The trial will last for a period of 30 days from the time a patient is included in the study. During this time, researchers will closely observe the health outcomes of the participants to gather information on the effectiveness of amiodarone in improving survival rates and reducing the recurrence of severe heart rhythm disturbances. This research could provide valuable insights into better treatment options for patients who have suffered a cardiac arrest outside of a hospital setting.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria. These include being at least 18 years old, having experienced an out-of-hospital cardiac arrest with an initial shockable rhythm, and being admitted to an intensive care unit. The cause of the cardiac arrest should be presumed cardiac or unknown. The time between return of spontaneous circulation (ROSC) and screening for randomization must be less than 6 hours. Informed consent is required from you or a surrogate, or consent may be deferred. You must be affiliated with or benefit from social insurance.

  2. Step 2

    Treatment administration

    The treatment involves the administration of amiodarone hydrochloride, a medication used to help manage heart rhythm problems. This is given as a solution for injection, specifically through an intravenous bolus injection or IV infusion. The medication is administered for a duration of 72 hours.

  3. Step 3

    Monitoring and follow-up

    Throughout the trial, your health will be closely monitored to observe any effects of the treatment. The primary focus is to determine if the administration of amiodarone reduces the incidence of a composite endpoint, which includes 30-day all-cause mortality and/or severe in-hospital ventricular arrhythmia recurrence. This includes conditions like ventricular fibrillation or ventricular tachycardia that require intervention, including re-arrest.

  4. Step 4

    Completion of the trial

    The trial concludes either upon discharge from the hospital or after 30 days, whichever occurs sooner. The primary endpoint is assessed at this time to evaluate the effectiveness of the treatment.

Who can join the trial?

7 criteria

  • Patient must be 18 years or older.
  • Must be admitted to an intensive care unit (a special hospital department for very sick patients).
  • Must have experienced an out-of-hospital cardiac arrest (heart stopped beating outside of a hospital) with an initial shockable rhythm (a type of heart rhythm that can be treated with a defibrillator).
  • The cause of the cardiac arrest must be presumed to be cardiac (related to the heart) or unknown.
  • The time between ROSC (return of spontaneous circulation, meaning the heart started beating again) and screening for the study must be less than 6 hours.
  • Must have informed consent (agreement to participate) from the patient, a surrogate (someone who can decide for the patient), or through deferred consent (agreement obtained after the study starts).
  • Must be affiliated with or benefiting from social insurance (having some form of health insurance coverage).

Who cannot join the trial?

6 criteria

  • Patients who have not experienced an out-of-hospital cardiac arrest with an initial shockable rhythm cannot participate. A shockable rhythm is a type of heart rhythm that can be treated with a defibrillator, a device that gives an electric shock to the heart.
  • Patients who are not critically ill after the cardiac arrest are excluded. Critically ill means being in a life-threatening condition that requires intensive medical care.
  • Patients who do not have a confirmed or presumed cardiac cause for their cardiac arrest are excluded. A cardiac cause means the heart is the reason for the cardiac arrest.
  • Patients who are not within the specified age range for the study cannot participate. The age range is not specified here, but it is important for eligibility.
  • Patients who are not part of the specified clinical trial group are excluded. The specific group is not detailed here, but it is necessary for participation.
  • Patients who are not considered part of a vulnerable population are excluded. Vulnerable populations may include groups like the elderly, children, or those with certain health conditions.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Amiodarone is a medication used in this clinical trial to help prevent irregular heartbeats in patients who have experienced a cardiac arrest outside of the hospital. It is given to patients who have a specific type of heart rhythm problem that can be life-threatening. The goal of using amiodarone in this trial is to see if it can reduce the chances of dying or having serious heart rhythm issues again within 30 days after the treatment starts. This medication works by helping to stabilize the heart's electrical activity, which can prevent dangerous heart rhythms from occurring.

What is already known about the treatment

Amiodarone – Amiodarone is administered intravenously, meaning it is given directly into a vein through an IV. It is currently being studied in clinical trials for its effectiveness in treating patients who have experienced an out-of-hospital cardiac arrest with an initial shockable rhythm. The main therapeutic use of amiodarone in this context is to prevent life-threatening heart rhythm problems, specifically ventricular fibrillation and ventricular tachycardia, which can occur after such cardiac events. At the molecular level, amiodarone works by blocking certain electrical signals in the heart that can cause irregular heartbeats. It is classified as an antiarrhythmic medication, which means it helps to maintain a normal heart rhythm.

Investigated diseases

Out-of-hospital cardiac arrest with initial shockable rhythm – This condition occurs when the heart suddenly stops beating effectively outside of a hospital setting, and the initial heart rhythm is one that can potentially be treated with a defibrillator shock. The most common shockable rhythms are ventricular fibrillation and pulseless ventricular tachycardia. In these rhythms, the heart's electrical activity becomes chaotic, preventing it from pumping blood effectively. If not treated promptly, this can lead to a lack of blood flow to vital organs, causing them to fail. The progression of this condition depends on the speed and effectiveness of the emergency response, including cardiopulmonary resuscitation (CPR) and defibrillation. Immediate medical intervention is crucial to restore a normal heart rhythm and improve the chances of recovery.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-510099-30-00Protocol codePARACA_P23/08Estimated enrolment674 patientsSponsorCentre Hospitalier De Versailles

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.