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

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What is this study about?

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.

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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Centre Hospitalier Victor Dupouy Argenteuil	Argenteuil	France
Centre Hospitalier Regional Et Universitaire De Brest	Brest	France
Oncopole Claudius Regaud	Toulouse	France

Other Sites

Site Name	City	Country
Centre Hospitalier De Versailles	Le Chesnay-Rocquencourt	France
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
Centre Hospitalier Groupe Hospitalier De La Rochelle Re Aunis	La Rochelle	France
Centre Hospitalier Public Du Cotentin	Cherbourg-En-Cotentin	France
Centre Hospitalier Sud Francilien	Corbeil Essonnes	France
Centre Hospitalier Intercommunal Toulon / La Seine-Sur-Mer	Toulon	France
Centre Hospitalier Universitaire d’Orléans	Orléans	France
Centre Hospitalier Universitaire De Nice	Nice	France
Centre Hospitalier Universitaire Amiens Picardie	Amiens	France
Centre Medico Chirurgical Ambroise Pare Hartmann	Neuilly-Sur-Seine	France
Groupe Hospitalier De La Region De Mulhouse Et Sud Alsace	Mulhouse	France
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hopital Beaujon	Clichy	France
Centre Hospitalier Universitaire De Caen Normandie	Caen	France
Cylvie Hvvugomllnr dc Cysqlodjtsdfafevlqvw	Charleville-Mézières	France
Ckfepw hiydhrqcgug da Bxcck	Brive La Gaillarde	France
Ckc dcobzpdxnririi	Epagny Metz Tessy	France
Hsrihcat cfozol Hygkt Mzyren iv Asythpqv	Aurillac	France
Adsjtqzkgd Pcdrwozb Hfmptxmq Ds Mijmrucud	Marseille	France
Gnqvbm Hoydciefcsb Ubwzpadbboody Pruti Pprjqctlavn Ej Ntdrdpyciywc	Paris	France
Cilxkd Hkigtvieqhc Rcqjqjmk Dgkesjjnyzdqoa	Angers	France
Hurgclq Jklsqc Cwrgjth Mstjs	Massy	France
Haphdcva Unebvjlfzenpgt Seohjocxit &lqctjr Hpnjhkt du Hjsqucfqmle	STRASBOURG, Alsace	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	01.10.2024

Trial locations

Investigated drugs:

Amiodarone Hydrochloride

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.

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 ID:

2023-510099-30-00

Protocol code:

PARACA_P23/08

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?