Intravenous Fish Oil based Lipid Emulsion to enhance recovery in High-Risk Cardiac Surgery Patients: a phase II multicenter trial
- Conditions
- critical illness, intensive care unit (ICU), surgeryTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- CTIS2023-503490-38-00
- Lead Sponsor
- Gcp-Service International West GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 120
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 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) a high perioperative risk profile, defined as predicted operative mortality of = 8% (European System for Cardiac Operative Risk Evaluation, EuroSCORE II). b) Age =70 c) 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%
1. Known hypersensitivity to FO / fish products or egg protein, 8. Patients receiving extracorporeal mechanical assist device (e.g. extracorporeal life support systems [ECLS], intra-aortic balloon pump [IABP]) or advanced heart failure therapies (e.g. total artificial heart [TAH], ventricular assist devices [VAD]), 9. Enrolment in any interventional trial within the last 30 days, 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)1, 14. Known severe coagulation disorder, 10. Already receiving FO-containing medical nutrition products, 11. Severe malnutrition (as defined by the body mass index [BMI] <18.5), 2. Pregnancy or lactation period, 3. Previous history of chronic or intermittent 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective is to demonstrate superiority of fish oil (FO) compared to placebo in the prevention of atrial fibrillation (AF) until 7 days after surgery. This clinical endpoint is assessed as part of the clinical practice.;Secondary Objective: Secondary objective is to show that FO enhances recovery after cardiac surgery compared to placebo.;Primary end point(s): Atrial fibrillation after cardiac surgery (AFACS), incorporating atrial fibrillation, atrial flutter and atrial tachycardia, until 7 days after surgery
- Secondary Outcome Measures
Name Time Method