Intravenous Fish Oil Based Lipid Emulsion to Enhance Recovery in High-Risk Cardiac Surgery Patients

Korábbi kezelés

• Previous history of chronic atrial fibrillation, atrial flutter and/or atrial tachyarrhythmia
• Patients receiving extracorporeal mechanical assist device (e.g. ECLS, or IABP) or advanced heart failure therapies (e.g. TAH, VAD)
• Already receiving special FO-enriched medical nutrition products

Más betegség

• Known hypersensitivity to fish oil/fish products or egg protein
• Known severe coagulation disorder

Laborértékek

• Severe chronic kidney dysfunction defined by the National Kidney Foundation (NKF) stage 4 and 5 by using the glomerular filtration rate (GFR <30ml/min)

Egyéb

• Pregnancy or lactation period
• 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
• 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
• Severe malnutrition (as defined by the BMI <18.5)
• Severe liver dysfunction defined by Child Pugh Class C.

• Written informed consent prior to study participation
• Adult patients (≥ 18 years)
• 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%