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

Intravenous Fish Oil Based Lipid Emulsion to Enhance Recovery in High-Risk Cardiac Surgery Patients: a Phase II Multicenter Trial - A Randomized, Placebo-controlled Trial -

This study is testing if giving fish oil to high-risk heart surgery patients can help them recover better and reduce heart rhythm problems after surgery.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 550 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: GCP-Service International West GmbH (Industry-sponsored)
• Locations: 10 sites (Augsburg and 9 other locations)
• Trial ID: NCT06279793 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults scheduled for elective cardiac surgery with a high-risk profile, including those undergoing CABG or valvular heart surgery.

Not a fit: Patients with known allergies to fish oil or fish products, or those who are pregnant or lactating, may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly enhance recovery times and reduce complications for patients undergoing high-risk cardiac surgery.

How similar studies have performed: While the use of fish oil in postoperative care is promising, this specific approach is novel and has not been extensively tested in similar high-risk cardiac surgery populations.

Eligibility criteria

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 anyinterventional trial within the last 30 days
10. Already receiving FO-containing 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 this trial is running

Augsburg and 9 other locations

• University Hospital Augsburg — Augsburg, Germany (Not_yet_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)
• University Hospital Mainz — Mainz, Germany (Recruiting)
• University Hospital Muenster — Münster, Germany (Recruiting)
• University Medical Center Rostock — Rostock, Germany (Not_yet_recruiting)
• Robert Bosch Medical Center — Stuttgart, Germany (Not_yet_recruiting)

Study contacts

• Study coordinator: Christian Stoppe, Prof. Dr.

Conditions Intensive Care Unit; Coronary Artery Bypass Grafting; High Risk Patients; Cardiopulmonary Bypass; Elective Cardiac Surgery; Valvular Heart Surgery; Multiple Valve Surgeries; Combined Cardiac Procedures