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Study on Amiodarone Hydrochloride for Treating Atrial Fibrillation in Critically Ill Patients

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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 hydrochloride in patients who are critically ill and have developed a condition known as new-onset atrial fibrillation. Atrial fibrillation is a type of irregular heartbeat that can lead to various complications if not managed properly. The study will compare two forms of amiodarone: one that is given through an intravenous infusion, which means it is delivered directly into the bloodstream, and another that is administered through an enteral feeding tube, which is a tube used to provide nutrition directly to the stomach or small intestine.

The purpose of this study is to understand how the body processes and responds to amiodarone when given in these two different ways. This involves measuring the levels of amiodarone and its active component, N-desethylamiodarone, in the blood, as well as in samples from the lungs and breath. The study will involve patients who are in the intensive care unit and are receiving mechanical ventilation, which is a machine that helps them breathe.

Participants in the study will receive either the standard intravenous form of amiodarone or the enteral form as part of their treatment for atrial fibrillation. The study will last for a maximum of seven days, during which the effects of the medication will be closely monitored. This research aims to provide valuable insights into the best way to administer amiodarone to critically ill patients with atrial fibrillation, potentially improving treatment outcomes for this condition.

The research process

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

Step 1
Joining the trial
Upon joining the trial, you will be admitted to the intensive care unit. This is where the study will take place.
You will receive a single dose of intravenous amiodarone ranging from 150 to 300 mg. This medication is used to treat your condition, which is new-onset atrial fibrillation.
Step 2
Continuous treatment
After the initial dose, you will continue to receive amiodarone as part of your treatment for atrial fibrillation.
The method of administration will be either through an intravenous infusion or an enteral feeding tube. This will be determined as part of the study.
Step 3
Monitoring and data collection
Throughout the trial, your health and response to the medication will be closely monitored.
Blood samples will be taken to measure the concentration of amiodarone and its active metabolite, N-desethylamiodarone.
Additional samples may be collected from your lungs and breath to further understand how the medication is working in your body.
Step 4
End of trial participation
Your participation in the trial will continue until the study's estimated end date, which is March 31, 2027, unless otherwise specified by the medical team.
At the end of the trial, a final assessment will be conducted to evaluate your overall health and the effects of the treatment.

Who can join the trial?

6 criteria

Adults who are 18 years of age or older.
Currently admitted to the intensive care unit (ICU), which is a special department in the hospital for very sick patients who need close monitoring and support.
Have been treated with a single dose of intravenous amiodarone (150-300 mg) for new-onset atrial fibrillation. Intravenous means the medicine is given directly into a vein.
Need continuous treatment with amiodarone for new-onset atrial fibrillation. Amiodarone is a medication used to help control heart rhythm.
Are invasively mechanically ventilated, meaning they are using a machine to help them breathe through a tube placed in their airway.
Have normal gastrointestinal function, which means they can be fed through a tube into their stomach without complications, and the amount of fluid taken out from the stomach is less than 300 mL per day.

Who cannot join the trial?

5 criteria

Patients who are not critically ill and mechanically ventilated cannot participate.
Patients who do not have new-onset atrial fibrillation cannot participate. Atrial fibrillation is a condition where the heart beats irregularly and often too fast.
Patients who are not within the specified age range cannot participate. The age range includes adults and older adults.
Patients who are not part of the specified clinical trial groups cannot participate.
Patients who are not part of the vulnerable population selected for this study cannot participate. A vulnerable population refers to groups of people who may be at a higher risk of harm or exploitation.

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Aalborg University Hospital
Aalborg, Denmark

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Investigated drugs

Amiodarone is a medication used to help control irregular heartbeats, specifically in patients with a condition called atrial fibrillation. In this clinical trial, researchers are comparing two ways of giving this medication to patients who are critically ill and on mechanical ventilation. One method is through an intravenous (IV) line, which means the medication is delivered directly into the bloodstream. This is the standard way of giving amiodarone in hospitals. The other method is enteral, which means the medication is given through a tube that goes into the stomach. The goal of the study is to understand how the body absorbs and processes amiodarone when given in these two different ways, by measuring the levels of the medication and its active form in the blood, lung fluid, and breath.

Amiodarone Hydrochloride

What is already known about the treatment

Amiodarone – Amiodarone is administered either intravenously or enterally, meaning it can be given directly into the bloodstream or through the digestive system. It is currently being studied in clinical trials to understand its behavior in the body, especially in critically ill patients with new-onset atrial fibrillation, a condition where the heart beats irregularly. The main use of amiodarone is to help control abnormal heart rhythms. At the molecular level, it works by affecting the electrical signals in the heart to help maintain a regular heartbeat. Amiodarone is classified as an antiarrhythmic medication, which means it is used to treat irregular heartbeats.

Investigated diseases

New-onset atrial fibrillation – Atrial fibrillation is a condition characterized by an irregular and often rapid heart rate. In new-onset atrial fibrillation, this irregular heartbeat begins suddenly and can cause poor blood flow. The heart's upper chambers (atria) beat chaotically and out of sync with the lower chambers (ventricles). This can lead to symptoms such as heart palpitations, shortness of breath, and weakness. The condition can vary in duration, with episodes lasting from minutes to hours or longer. Over time, if not managed, it can lead to complications related to the heart's function.