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

Verified siteRegistered drugNo placebo
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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 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.

The research process

The trial runs in 5 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, 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. Step 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. Step 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. Step 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. Step 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 trial?

9 criteria

  • 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 trial?

2 criteria

  • 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.
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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.

What is already known about the treatment

Fish Oil based Lipid Emulsion – This medication is administered intravenously, meaning it is given directly into a vein through an IV. It is currently being studied in clinical trials to assess its effectiveness in helping patients recover from high-risk cardiac surgery, particularly in preventing atrial fibrillation, a common heart rhythm problem, within seven days after surgery. The main therapeutic use of this medication is to support recovery in patients who are critically ill or undergoing surgery, especially those in intensive care units. At the molecular level, fish oil is believed to work by reducing inflammation and stabilizing heart cell membranes, which may help prevent irregular heartbeats. It is classified pharmacologically as a lipid emulsion, which is a type of fat-based solution used in medical treatments.

Investigated diseases

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 detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-503490-38-00Protocol codeMODIFY CSXEstimated enrolment378 patientsSponsorGcp-Service International West GmbH

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

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