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

RecruitingPhase 2Ages 18 Years - anyAllGCP-Service International West GmbH
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion 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 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 Criteria: 1. Known hypersensitivity to fish oil/fish products or egg protein 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 8. Patients receiving extracorporeal mechanical assist device (e.g. ECLS, or IABP) or advanced heart failure therapies (e.g. TAH, 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 10. Already receiving special FO-enriched medical nutrition products 11. Severe malnutrition (as defined by the BMI \<18.5) 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) 14. Known severe coagulation disorder
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What it tests

  • Fish Oil
  • Intravenous 0.9% Sodium Chloride
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Where

10 sites
University Hospital Augsburg
Augsburg, Germany
Charité Universitätsmedizin Berlin
Berlin, Germany
University of Bonn
Bonn, Germany
University Hospital Goettingen
Göttingen, Germany
University Hospital Hamburg-Eppendorf
Hamburg, Germany
University Medical Center Schleswig-Holstein
Kiel, Germany
University Hospital Mainz
Mainz, Germany
University Hospital Muenster
Münster, Germany

…and 2 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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