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NCT06279793RecruitingPhase 2

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

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 -

Source: ClinicalTrials.gov · Last updated 8 Jul 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
550 (estimated)
First submitted
13 Sept 2023
Start date
15 Feb 2024
Primary completion date
Mar 2030
Lead sponsor
GCP-Service International West GmbH
NCT number
NCT06279793

What you commit to

  • Study type: Interventional · Phase 2
  • Planned participants: 550
  • From 15 Feb 2024 to the primary completion date, Mar 2030
  • 10 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Other illness

  • Known hypersensitivity to fish oil/fish products or egg protein
  • Known severe coagulation disorder

Lab values

  • Severe chronic kidney dysfunction defined by the National Kidney Foundation (NKF) stage 4 and 5 by using the glomerular filtration rate (GFR \<30ml/min)

Other

  • 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.

Who the study is looking for

  • 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%

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (10)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University Hospital Augsburg
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AugsburgGermanyRecruiting
Charité Universitätsmedizin Berlin
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BerlinGermanyRecruiting
University of Bonn
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BonnGermanyRecruiting
University Hospital Goettingen
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GöttingenGermanyRecruiting
University hospital Hamburg Eppendorf
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HamburgGermanyRecruiting
University Medical Center Schleswig-Holstein
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KielGermanyRecruiting
University Hospital Mainz
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MainzGermanyRecruiting
University hospital Muenster
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MünsterGermanyRecruiting
University Medical Center Rostock
Coordinator of this site? Confirm its status
RostockGermanyNot yet recruiting
Robert Bosch Medical Center
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StuttgartGermanyRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.