Study on Epinephrine and Amiodarone for Patients with Cardiac Arrest Outside the Hospital

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What is this study about?

This clinical trial is focused on studying the treatment of out-of-hospital cardiac arrest, a condition where the heart suddenly stops beating outside of a hospital setting. The study will compare two types of medications: epinephrine and amiodarone. Epinephrine, also known as adrenaline, is a medication that can help restart the heart by increasing blood flow. Amiodarone is used to help stabilize the heart’s rhythm. Both medications will be given through a method called intravenous bolus use, which means they are injected directly into the bloodstream in a single, quick dose.

The purpose of this study is to find out if there is a difference in the return of a normal heartbeat, known as return of spontaneous circulation (ROSC), depending on the type of access used to deliver the medication. The study will compare two methods of delivering the medication: through a vein (intravenous) or directly into the bone (intraosseous). Participants in the study will receive one of these treatments during a cardiac arrest situation outside of a hospital.

The study will monitor participants to see if their heart starts beating again and if they survive. It will also look at their brain function 30 days after the event, using a scale called the modified Rankin Scale (mRS), which measures how well a person can perform daily activities. The study aims to provide valuable information on the best way to treat cardiac arrest outside of a hospital setting.

1 joining the trial

Upon joining the trial, you will be informed about the study’s purpose, which is to determine if there is a difference in the return of spontaneous circulation depending on the type of vascular access used during an out-of-hospital cardiac arrest.

You will be eligible to participate if you are 18 years or older and have experienced an out-of-hospital cardiac arrest requiring intravenous or intraosseous vascular access.

2 treatment administration

During the trial, you will receive medications through either intravenous or intraosseous access. The medications used in this trial are epinephrine and amiodarone.

Epinephrine and amiodarone will be administered as an intravenous bolus, which means they will be given directly into your bloodstream in a single, quick dose.

3 monitoring and assessment

Your response to the treatment will be closely monitored to check for a sustained return of spontaneous circulation (ROSC). This means that your heart starts beating on its own without the need for chest compressions for more than 20 minutes.

Your survival and neurological outcome will be assessed 30 days after the treatment. The neurological outcome will be evaluated using the modified Rankin Scale, which measures the degree of disability or dependence in daily activities.

4 completion of the trial

The trial is expected to end by March 1, 2024. Your participation will contribute to understanding the effectiveness of different vascular access methods during cardiac arrest.

Who Can Join the Study?

The patient must have experienced an out-of-hospital cardiac arrest. This means the heart stopped beating effectively outside of a hospital setting.
The patient must be 18 years of age or older.
There must be a need for either intravenous (IV) or intraosseous (IO) vascular access during the cardiac arrest. This means that during the cardiac arrest, the patient needs to have a method for delivering medications or fluids directly into the bloodstream (IV) or into the bone marrow (IO).

Who Cannot Join the Study?

Patients who have not experienced an out-of-hospital cardiac arrest cannot participate. This means the heart stopped beating outside of a hospital setting.
Patients who are not within the specified age range cannot participate. The study includes certain age groups only.
Patients who belong to a vulnerable population are not eligible. This refers to groups who may need special protection or care.

Where you can join this trial?

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Other Sites

Site Name	City	Country
Præhospitalet	Aarhus	Denmark
Den Praehospitale Virksomhed	Aalborg	Denmark
Praehospital indsats Region Syddanmark	Vejle	Denmark
Plajnumzfwfc Cyndvbf Rlbtdq Sglrloht	Næstved	Denmark
Rlyioq Hfgesctwbauv Abaexuugbisov	Ballerup	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Not recruiting	18.05.2022

Trial locations

Investigated drugs:

Adrenaline Tartrate Ph. Eur.

Intravenous Access is a method used to deliver medications and fluids directly into a vein. In this trial, it is being used to quickly provide necessary treatments to patients experiencing cardiac arrest outside of a hospital setting. This method is commonly used in emergency situations because it allows for fast and efficient delivery of life-saving medications.

Intraosseous Access is a technique where medications and fluids are delivered directly into the bone marrow. This method is used when it is difficult to find a vein, especially in emergency situations like cardiac arrest. It provides a rapid way to administer treatments when time is critical, ensuring that the patient receives the necessary care as quickly as possible.

Out-of-hospital cardiac arrest (OHCA) – This condition occurs when the heart suddenly stops beating effectively outside of a hospital setting, leading to a cessation of blood flow to the brain and other vital organs. It is often caused by an electrical malfunction in the heart that results in an irregular heartbeat, or arrhythmia. Without immediate intervention, the lack of blood flow can cause damage to the brain and other organs. The progression of OHCA is rapid, with loss of consciousness occurring within seconds to minutes. If circulation is not restored quickly, it can lead to severe neurological damage. The primary goal in managing OHCA is to achieve a return of spontaneous circulation, where the heart resumes effective pumping of blood.

Trial ID:

2022-500744-38-00

Protocol code:

2.2

NCT ID:

NCT05205031

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Epinephrine and Amiodarone for Patients with Cardiac Arrest Outside the Hospital

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?