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Intravenous Fish Oil based Lipid Emulsion to enhance recovery in High-Risk Cardiac Surgery Patients: a phase II multicenter trial
EU CTIS ID: 2023-503490-38-00
What this study is testing
The primary objective is to demonstrate superiority of fish oil (FO) compared to placebo in the prevention of atrial fibrillation after cardiac surgery (AFACS), incorporating atrial fibrillation, atrial flutter and atrial tachycardia, until 7 days after surgery. This clinical endpoint is assessed as part of the clinical practice.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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) one of the following surgical procedures: -valvular heart surgery only, -coronary artery bypass graft (CABG), -combined valve and CABG, -multiple valve surgeries, -combined cardiac surgical procedures, -aortic surgical procedures (aortic arch and/or descending aorta; aortic valve+ascending aorta), -combined cardiac and aortic surgical procedures (ii) and at least 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%
You likely can't join if
- 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 other interventional trial will be discussed with the coordinating investigator on a case-by-case scenario and requires sponsor approval before inclusion
- 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
See the full eligibility 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 cardiopulmonary bypass (CPB), who are defined as high risk based on having (i) one of the following surgical procedures: -valvular heart surgery only, -coronary artery bypass graft (CABG), -combined valve and CABG, -multiple valve surgeries, -combined cardiac surgical procedures, -aortic surgical procedures (aortic arch and/or descending aorta; aortic valve+ascending aorta), -combined cardiac and aortic surgical procedures (ii) and at least 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 other interventional trial will be discussed with the coordinating investigator on a case-by-case scenario and requires sponsor approval before inclusion
- 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 special FO-enriched 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 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.