Intravenous Fish Oil Based Lipid Emulsion to Enhance Recovery in High-Risk Cardiac Surgery Patients
Recruiting now · Phase 2 · Has a placebo group
Conditions studied: Intensive Care Unit, Coronary Artery Bypass Grafting (CABG), High Risk Patients, Cardiopulmonary Bypass, Elective Cardiac Surgery, Valvular Heart Surgery, Multiple Valve Surgeries, Combined Cardiac Procedures, Aortic Surgical Procedures, Adult Patients ≥ 18 Years, Combined Valve and CABG, Combined Cardiac and Aortic Surgical Procedures
In brief
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.
Key facts
- Study ID
- NCT06279793
- Run by
- GCP-Service International West GmbH
- People needed
- 550
- Starts
- 2024-02-15
- Expected to finish
- 2030-09-01
- Last updated by the study team
- 2026-07-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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%
You may not qualify if…
- Known hypersensitivity to fish oil/fish products or egg protein
- Pregnancy or lactation period
- Previous history of chronic 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 extracorporeal mechanical assist device (e.g. ECLS, or IABP) or advanced heart failure therapies (e.g. TAH, VAD)
- 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
- Already receiving special FO-enriched 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)
- Known severe coagulation disorder
Where it is running
- Robert Bosch Medical Center — Stuttgart, Germany (enrolling)
- Charité Universitätsmedizin Berlin — Berlin, Germany (enrolling)
- University of Bonn — Bonn, Germany (enrolling)
- University Hospital Goettingen — Göttingen, Germany (enrolling)
- University Hospital Hamburg-Eppendorf — Hamburg, Germany (enrolling)
- University Medical Center Schleswig-Holstein — Kiel, Germany (enrolling)
- University Hospital Mainz — Mainz, Germany (enrolling)
- University Hospital Muenster — Münster, Germany (enrolling)
- University Hospital Augsburg — Augsburg, Germany (enrolling)
- University Medical Center Rostock — Rostock, Germany
Full record on ClinicalTrials.gov
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