Study on Fish Oil Emulsion for Preventing Atrial Fibrillation in High-Risk Cardiac Surgery Patients

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What is this study about?

This clinical trial is focused on patients undergoing high-risk heart surgery. The study is investigating the use of an intravenous treatment called Omegaven-Fresenius Emulsion zur Infusion, which contains ingredients like glycerol, highly refined fish oil, and purified egg phospholipids. The purpose of the study is to see if this treatment can help prevent a heart rhythm problem known as atrial fibrillation that can occur after heart surgery.

Participants in the study will receive either the fish oil-based treatment or a placebo. The study will monitor the occurrence of atrial fibrillation for up to seven days after surgery. Other aspects of recovery, such as the time it takes to leave the hospital and overall survival, will also be observed. The study aims to enhance recovery and improve outcomes for patients who are at high risk during heart surgery.

The trial will take place over a period of time, with participants being closely monitored for any changes in their health. The study will also look at various factors like the length of stay in the hospital, the need for additional medical support, and any complications that may arise. The goal is to gather information that could lead to better care and recovery for patients undergoing complex heart surgeries.

1 joining the study

Upon joining the study, you will be required to provide written informed consent. This means you agree to participate after understanding the details and potential risks of the study.

You must be an adult, aged 18 or older, and scheduled for elective cardiac surgery using a heart-lung machine. You should be considered high risk based on specific criteria, such as having certain types of surgeries or additional risk factors like age or heart function.

2 pre-surgery preparation

Before your surgery, you will receive an intravenous infusion of a fish oil-based lipid emulsion called Omegaven-Fresenius. This is a special mixture given through a vein to help with recovery.

The infusion will be administered as part of your routine care in the hospital.

3 surgery and immediate recovery

During your surgery, doctors will monitor your heart closely to prevent and manage any irregular heartbeats, known as atrial fibrillation. This monitoring will continue for up to 7 days after your surgery.

You will be in the intensive care unit (ICU) for close observation and care as you begin your recovery.

4 post-surgery monitoring

After surgery, your recovery will be closely monitored. This includes checking how quickly you can be discharged from the hospital and how many days you spend outside the hospital.

Doctors will assess your overall health, including any organ function issues, the need for mechanical breathing support, and any signs of stroke or kidney injury.

5 follow-up and assessment

Your progress will be evaluated using various scoring systems to measure your health status and recovery. This includes assessments of your daily living activities and quality of life.

Any side effects or adverse events related to the treatment will be recorded and addressed.

Who Can Join the Study?

Provide written informed consent before joining the study. This means you agree to participate after being informed about the study details.
Be an adult, which means you must be 18 years or older.
Be scheduled for elective cardiac surgery using a heart-lung machine, known as cardiopulmonary bypass (CPB). This is planned heart surgery where a machine temporarily takes over the function of the heart and lungs during the operation.
Be considered high risk for surgery. This includes having:
- Combined valve or coronary artery bypass graft (CABG) surgery, or multiple valve surgeries, or combined heart and aorta surgeries.
- One of the following additional risk factors:
  - A high risk of complications during surgery, with a predicted chance of death of 8% or more, as measured by a specific scoring system called EuroSCORE II.
  - Being 70 years old or older.
  - A Clinical Frailty Score of 4 or more, which is a measure of your overall health and ability to perform daily activities.
  - Needing urgent surgery, which means the surgery must be done within 24-48 hours after being admitted to the hospital.
  - A left ventricular ejection fraction of less than 35%. This is a measure of how well your heart is pumping blood.

Who Cannot Join the Study?

Patients who are currently experiencing a critical illness or are in an intensive care unit (ICU) cannot participate.
Patients who have undergone surgery recently are not eligible.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Universitaetsmedizin Goettingen	Goettingen	Germany
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz	Mainz	Germany
Rostock University Medical Center	Rostock	Germany

Other Sites

Site Name	City	Country
Robert Bosch Krankenhaus GmbH	Stuttgart	Germany
Rheinische Friedrich-Wilhelms-Universitaet Bonn	Bonn	Germany
Universitaetsklinikum Aachen AöR	Aachen	Germany
Universitaetsklinikum Schleswig-Holstein AöR	Kiel	Germany
Deutsches Herzzentrum Berlin	Berlin	Germany
Uduntbojzq Maifzxl Chkutd Hulmtmjvrchzbzozi	Hamburg	Germany
Uzsmfyysqflqrmpxpdwtn Azhkvfpx	Augsburg	Germany
Uuzcfztwybbmizqtfjelr Mzabrhox Ake	Munster	Germany
Uzylsezsnafigprkbghkk Whntrptmx Azt	Wuerzburg	Germany

Trial status

Country	Status	Recruitment Start
Germany	Recruiting	01.10.2023

Trial locations

Investigated drugs:

Fish Oil based Lipid Emulsion is a type of therapy that involves using a special mixture of fats derived from fish oil. This therapy is given through an intravenous (IV) line, which means it is delivered directly into the bloodstream. The goal of using this fish oil emulsion in the trial is to help patients recover better after high-risk heart surgery. Specifically, it aims to prevent a common heart rhythm problem called atrial fibrillation, which can occur after surgery. By using this fish oil therapy, the trial hopes to show that it can reduce the chances of developing this heart issue within the first week after surgery.

Investigated diseases:

Critical illness

Atrial Fibrillation – Atrial fibrillation is a heart condition characterized by an irregular and often rapid heart rate. It occurs when the upper chambers of the heart (atria) beat out of coordination with the lower chambers (ventricles). This can lead to poor blood flow and symptoms such as heart palpitations, shortness of breath, and fatigue. The condition can be intermittent or persistent, with episodes that may last from minutes to hours or even longer. Over time, atrial fibrillation can contribute to the development of blood clots, which may increase the risk of stroke. The progression of the disease can vary, with some individuals experiencing worsening symptoms and others remaining stable.

Trial ID:

2023-503490-38-00

Protocol code:

MODIFY CSX

NCT ID:

NCT06279793

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Fish Oil Emulsion for Preventing Atrial Fibrillation in High-Risk Cardiac Surgery Patients

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