Intravenous Fish Oil Based Lipid Emulsion to Enhance Recovery in High-Risk Cardiac Surgery Patients.
The proposing study is a randomized, double-blind, controlled trial of about 120 patients in 10 centers in Germany. This trial will be started in Germany and recruited mainly at powerful German heart centers only.

In this prospective randomized controlled blinded multicenter trial, a total of 120 high-risk cardiac surgery patients will receive either standard of care + OMEGAVEN at 0.20 g/kg ideal body weight (IBW) versus placebo + standard of care.
- EligibilityCriteria: Inclusion Criteria:  Written informed consent prior to study participation Adult patients (≥ 18 years)  Patients scheduled to undergo elective cardiac surgery with the use of cardiopulmonary bypass (CPB), who are defined as high risk based on having (i) combined valve/coronary artery bypass graft (CABG) or multiple valve surgeries, or combined cardiac/aortic surgical procedures and (ii) one of the following additional risk factors:  a high perioperative risk profile, defined as predicted operative mortality of ≥ 8% (European System for Cardiac Operative Risk Evaluation, EuroSCORE II). Age >70 Clinical Frailty Score 4 or more Urgent surgery (defined as to be performed within 24-48 hours after admission) Left ventricular ejection fraction <35%  Exclusion Criteria:  Known hypersensitivity to fish oil (FO)/ fish products or egg protein Pregnancy or lactation period Previous history of atrial fibrillation, atrial flutter and/or atrial tachyarrhythmia Inability or unwillingness of individual to give written informed consent Not expected to survive an additional 48 hours from screening evaluation Lack of commitment to full, aggressive care (anticipated withholding or withdrawing treatments in the first week but isolated "Do not Resuscitate" (DNR) acceptable) Patients admitted with diabetic ketoacidosis or non-ketotic hyperosmolar coma Patients receiving and extracorporeal mechanical assist device (e.g. extracorporal life support systems [ECLS], or intra-aortic ballon pump [IABP]) or for advanced heart failure therapies (e.g. platelet aggregation inhibitors [TAH], ventricular assist devices [VAD]) Enrolment in anyinterventional trial within the last 30 days Already receiving FO-containing medical nutrition products Severe malnutrition (as defined by the BMI<18.5) Severe liver dysfunction defined by Child Pugh Class C. Severe chronic kidney dysfunction defined by the National Kidney Foundation (NKF) stage 4 and 5 by using the glomerular filtration rate (GFR < 30ml/min)1 Known severe coagulation disorder - HealthyVolunteers: No - Gender: All - MinimumAge: 18 Years - StdAgeList: Adult, Older Adult