Actively Recruiting
Intravenous Fish Oil Based Lipid Emulsion to Enhance Recovery in High-Risk Cardiac Surgery Patients
Led by GCP-Service International West GmbH · Updated on 2026-02-23
550
Participants Needed
10
Research Sites
341 weeks
Total Duration
On this page
Sponsors
G
GCP-Service International West GmbH
Lead Sponsor
U
University Hospital, Bonn
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Intravenous Fish Oil Based Lipid Emulsion to Enhance Recovery in High-Risk Cardiac Surgery Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent prior to study participation
- Adult patients (18 years or older)
- Scheduled for elective cardiac surgery using cardiopulmonary bypass
- Undergoing one of the following surgeries: valvular heart surgery only, coronary artery bypass grafting, combined valve and bypass surgery, multiple valve surgeries, combined cardiac procedures, or aortic surgical procedures (including aortic arch, descending aorta, aortic valve and ascending aorta)
- At least one additional risk factor: predicted operative mortality of 8% or higher (EuroSCORE II), age 70 or older, Clinical Frailty Score 4 or higher, urgent surgery within 24-48 hours of admission, or left ventricular ejection fraction less than 35%
You will not qualify if you...
- Known hypersensitivity to fish oil, fish products, or egg protein
- Pregnancy or lactation
- History of chronic atrial fibrillation, atrial flutter, or atrial tachyarrhythmia
- Unable or unwilling to provide written informed consent
- Not expected to survive more than 48 hours from screening
- Lack of commitment to full aggressive care (except isolated Do Not Resuscitate orders)
- Admission with diabetic ketoacidosis or non-ketotic hyperosmolar coma
- Receiving extracorporeal mechanical assist devices or advanced heart failure therapies
- Participation in another interventional trial within the last 30 days
- Already receiving fish oil-containing medical nutrition
- Severe malnutrition (BMI less than 18.5)
- Severe liver dysfunction (Child Pugh Class C)
- Severe chronic kidney dysfunction (glomerular filtration rate less than 30 ml/min, National Kidney Foundation stage 4 or 5)
- Known severe coagulation disorder
AI-Screening
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Trial Site Locations
Total: 10 locations
1
University Hospital Augsburg
Augsburg, Germany
Not Yet Recruiting
2
Charité Universitätsmedizin Berlin
Berlin, Germany
Actively Recruiting
3
University of Bonn
Bonn, Germany
Actively Recruiting
4
University Hospital Goettingen
Göttingen, Germany
Actively Recruiting
5
University Hospital Hamburg-Eppendorf
Hamburg, Germany
Actively Recruiting
6
University Medical Center Schleswig-Holstein
Kiel, Germany
Actively Recruiting
7
University Hospital Mainz
Mainz, Germany
Actively Recruiting
8
University Hospital Muenster
Münster, Germany
Actively Recruiting
9
University Medical Center Rostock
Rostock, Germany
Not Yet Recruiting
10
Robert Bosch Medical Center
Stuttgart, Germany
Not Yet Recruiting
Research Team
C
Christian Stoppe, Prof. Dr.
CONTACT
E
Ellen Dresen, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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