Using fish oil to improve recovery in high-risk cardiac surgery patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effects of an intravenous fish oil-based lipid emulsion on recovery outcomes in high-risk cardiac surgery patients. A total of 120 participants will be randomly assigned to receive either fish oil or a placebo alongside standard care. The primary goal is to reduce the incidence of postoperative atrial fibrillation, which may lead to quicker discharges from the ICU and improved long-term health outcomes. The study will monitor patients until their discharge from the ICU or for a maximum of seven days post-surgery.

Why it matters

Who can join: the full rules

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

Where it's running

• University Hospital Augsburg
  Augsburg, Germany Recruiting
• Charité Universitätsmedizin Berlin
  Berlin, Germany Recruiting
• University of Bonn
  Bonn, Germany Recruiting
• University Hospital Goettingen
  Göttingen, Germany Recruiting
• University Hospital Hamburg-Eppendorf
  Hamburg, Germany Recruiting
• University Medical Center Schleswig-Holstein
  Kiel, Germany Recruiting

Study contacts

• Study coordinator: Christian Stoppe, Prof. Dr.
• Email: cstoppe@gcp-service.com
• Phone: 49-931-20130001

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.