Fish Oil Lipid Drip Tested in High-Risk Heart Surgery Patients
Tests intravenous fish oil against saline placebo in adults having high-risk heart surgery.
Plain-language title generated from the registry record
Registry title: Intravenous Fish Oil Based Lipid Emulsion to Enhance Recovery in High-Risk Cardiac Surgery Patients
Key facts
- Where
- Augsburg, Berlin, Bonn, Göttingen, Hamburg, Kiel, Mainz, Münster, Rostock, and Stuttgart, GermanySee the 10 sites
- Phase
- Phase 2
Where in Germany
- University Hospital AugsburgAugsburg, GermanyTaking people
- Charité Universitätsmedizin BerlinBerlin, GermanyTaking people
- University of BonnBonn, GermanyTaking people
- University Hospital GoettingenGöttingen, GermanyTaking people
- University hospital Hamburg EppendorfHamburg, GermanyTaking people
- University Medical Center Schleswig-HolsteinKiel, GermanyTaking people
- University Hospital MainzMainz, GermanyTaking people
- University hospital MuensterMünster, GermanyTaking people
- University Medical Center RostockRostock, GermanyNot yet recruiting
- Robert Bosch Medical CenterStuttgart, GermanyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- GCP-Service International West GmbH
- Trial code
- NCT06279793
- Record updated
- 8 July 2026
- Original description
The MODIFY CSX study is a prospective, randomized, placebo-controlled trial conducted in heart centers in Germany and Italy.Read full original descriptionShow less
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 -
The MODIFY CSX study is a prospective, randomized, placebo-controlled trial conducted in heart centers in Germany and Italy.
A total of 550 high-risk cardiac surgery patients will receive either 0.20 g fish oil/kg body weight (BW) + standard of care versus same volume of placebo (NaCl) + standard of care.
Inclusion: 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%.
Exclusion: 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; Known hypersensitivity to fish oil/fish products or egg protein; Known severe coagulation disorder; Severe chronic kidney dysfunction defined by the National Kidney Foundation (NKF) stage 4 and 5 by using the glomerular filtration rate (GFR <30ml/min); 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.