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Fish oil infusion may shield heart surgery patients from dangerous rhythm disorder

NCT ID NCT06279793

Prevention Sponsor: GCP-Service International West GmbH Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 09, 2026 · Updated 2 times

Summary

This study tests whether giving fish oil through a vein during heart surgery can prevent a common complication called atrial fibrillation (irregular heartbeat) and help patients recover faster. About 550 high-risk adults having elective heart surgery will receive either fish oil or a placebo (salt water) alongside standard care. The main goal is to see if fish oil reduces atrial fibrillation in the first week after surgery.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 550 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2024

Expected to finish

Sep 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Written informed consent prior to study participation 2. Adult patients (≥ 18 years) 3. Patients scheduled to undergo elective cardiac surgery with the use of CPB, who are defined as high risk based on having (i) one of the following surgical procedures: valvular heart surgery only, CABG, combined valve and CABG, multiple valve surgeries, combined cardiac procedures, aortic surgical procedures (aortic arch and/or descending aorta; aortic valve+ascending aorta) and (ii) at least one of the following additional risk factors: (a) a high perioperative risk profile, defined as predicted operative mortality of ≥8% (EuroSCORE II), (b) age ≥70, (c) Clinical Frailty Score 4 or more, (d) urgent surgery (defined as to be performed within 24-48 hours after admission), (e) left ventricular ejection fraction \<35% Exclusion Criteria: 1. Known hypersensitivity to fish oil/fish products or egg protein 2. Pregnancy or lactation period 3. Previous history of chronic atrial fibrillation, atrial flutter and/or atrial tachyarrhythmia 4. Inability or unwillingness of individual to give written informed consent 5. Not expected to survive an additional 48 hours from screening evaluation 6. Lack of commitment to full, aggressive care (anticipated withholding or withdrawing treatments in the first week but isolated "Do not Resuscitate" \[DNR\] acceptable) 7. Patients admitted with diabetic ketoacidosis or non-ketotic hyperosmolar coma 8. Patients receiving extracorporeal mechanical assist device (e.g. ECLS, or IABP) or advanced heart failure therapies (e.g. TAH, VAD) 9. Enrolment in any other interventional trial will be discussed with the coordinating investigator on a case-by-case scenario and requires sponsor approval before inclusion 10. Already receiving special FO-enriched medical nutrition products 11. Severe malnutrition (as defined by the BMI \<18.5) 12. Severe liver dysfunction defined by Child Pugh Class C. 13. Severe chronic kidney dysfunction defined by the National Kidney Foundation (NKF) stage 4 and 5 by using the glomerular filtration rate (GFR \<30ml/min) 14. Known severe coagulation disorder

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Conditions

The condition(s) this trial relates to.

aortic disorder atrial fibrillation atrial flutter coronary artery disorder heart valve disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Adult patients ≥ 18 years Aortic surgical procedures Cardiopulmonary bypass Combined cardiac and aortic surgical procedures Combined cardiac procedures Combined valve and cabg Coronary artery bypass grafting (CABG) Elective cardiac surgery High risk patients Intensive care unit Multiple valve surgeries Valvular heart surgery

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    10 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Charité Universitätsmedizin Berlin

    RECRUITING

    Berlin, Germany

  • Robert Bosch Medical Center

    RECRUITING

    Stuttgart, Germany

  • University Hospital Augsburg

    RECRUITING

    Augsburg, Germany

  • University Hospital Goettingen

    RECRUITING

    Göttingen, Germany

  • University Hospital Hamburg-Eppendorf

    RECRUITING

    Hamburg, Germany

  • University Hospital Mainz

    RECRUITING

    Mainz, Germany

  • University Hospital Muenster

    RECRUITING

    Münster, Germany

  • University Medical Center Rostock

    NOT_YET_RECRUITING

    Rostock, Germany

  • University Medical Center Schleswig-Holstein

    RECRUITING

    Kiel, Germany

  • University of Bonn

    RECRUITING

    Bonn, Germany

More trials for these conditions

Other studies related to the condition(s) this trial covers.