A Phase 2 interventional study of Fish Oil and Intravenous 0.9% Sodium Chloride in Intensive Care Unit, Coronary Artery Bypass Grafting (CABG) and High Risk Patients, sponsored by GCP-Service International West GmbH. Recruiting at 10 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-08.
Sponsored by GCP-Service International West GmbH · Phase 2, Interventional, and Prevention
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.
The proposed hypothesis is that the therapeutic strategy tested in this randomized trial will decrease the occurrence of postoperative atrial fibrillation, which ultimately leads to faster time to discharge alive. This in turn significantly improves the patients' mid and long-term outcomes and dramatically reduces associated healthcare related costs.
Duration of intervention: until discharge from ICU, death or postoperative day 7 on ICU, whichever comes first.
Treatment Group: Patients will receive 0.20 g fish oil/kg BW/d (≙ 2 mL Omegaven®/kg BW/d).
Control Group: Patients will receive 0,9% NaCl in dose 2 mL/kg BW/d (placebo).
Follow-up per patient: at day 30, months 3, 6, and 12.
Primary endpoint (Phase II study):
The primary endpoint for this phase II clinical trial is the onset and occurence of atrial fibrillation after cardiac surgery (AFACS), incorporating atrial fibrillation, atrial flutter, and atrial tachycardia, until day 7 after surgery (on ICU and normal ward).
4,009 studies on the registry are indexed under Atrial Fibrillation; 961 are open to participants now.
This study's planned enrollment of 550 is above the median of 150 across 2,476 interventional studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →GCP-Service International West GmbH is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients will receive 0.20 g fish oil/kg BW/d (≙2 mL Omegaven®/kg BW/d).
Drug: Fish Oil
Patients will receive 0,9% NaCl in volume 2 mL/kg BW/d (placebo).
Drug: Intravenous 0.9% Sodium Chloride
Omegaven® is a 10% fish oil emulsion with a high percentage of long-chain n-3 fatty acids - mainly eicosapentaenoic acid and docosahexaenoic acid. It optimises the fatty acid pattern in parenteral nutrition and is a source of polyunsaturated n-3 fatty acids as cell membrane components and precursors for eicosanoids. Omegaven® is manufactured by Fresenius-Kabi, Germany and is available in 100 mL bottles for study purpose. Each 100 mL of Omegaven® contains 10 g of fish oil (0.1 g/mL). Timeframe: Day -1: 0.20 g fish oil/kg BW/d (the treatment should be started 24 to 3 h before surgery, can be given as 3-6 hours infusion); intraoperative day 0: no dose; postoperative day 0: 0.20 g fish oil/kg BW/d; postoperative days 1 to max. 7): 0.20 g fish oil/kg BW/d
Also known as: Omegaven®
Intravenous 0.9% Sodium Chloride (volume 2 mL/kg BW/d) provided at the same timepoints as the intervention.
Also known as: Saline Infusion
Atrial fibrillation
The primary objective is to demonstrate superiority of fish oil compared to placebo in the prevention of atrial fibrillation after cardiac surgery (AFACS), incorporating atrial fibrillation, atrial flutter and atrial tachycardia, until 7 days after surgery. This clinical endpoint is assessed as part of the clinical practice.
Time frame: Postoperative days 0-7
Mechanical ventilation
Duration of mechanical ventilation
Time frame: Postoperative days 0-7, ICU discharge (approximately 3-4 days after surgery), hospital discharge (approximately 1-2 weeks after surgery), day 30 follow-up
Adverse Events
AEs leading to discontinuation/AEs at least possibly related to the IMP/SAEs
Time frame: Preoperative day -1 to 12 months follow-up
Delta Sequential Organ Failure Assessment Score (SOFA) Score
A scoring system that assesses the performance of several organ systems in the body (neurologic, blood, liver, kidney, and blood pressure/hemodynamics) and assigns a score based on the data obtained in each category.
Time frame: Postoperative days 0-7
Stroke
Incidence of stroke
Time frame: Postoperative days 0-7
Inotropics/vasopressors
Duration of inotropic/vasopressor support
Time frame: Postoperative days 0-7, ICU discharge (approximately 3-4 days after surgery), hospital discharge (approximately 1-2 weeks after surgery), day 30 follow-up
Acute Kidney Injury
Kidney Disease: Improving Global Outcomes \[KDIGO\] stages 1-3
Time frame: Postoperative days 0-7
Infection rate
Number of infections
Time frame: Postoperative days 0-7
Survival status
Overall survival
Time frame: ICU discharge (approximately 3-4 days after surgery), hospital discharge (approximately 1-2 weeks after surgery), day 30 follow-up, months 3, 6, and 12 follow-up
Quality of Life (SF-36)
To measure the quality of life
Time frame: Screening (preoperative day -7 until day -1), day 30 follow-up, 3, 6, and 12 months follow-up
Postoperative bleeding
Bleeding after surgery
Time frame: Postoperative days 0-7
Time to ICU discharge alive
Number of days alive in the ICU
Time frame: ICU discharge (approximately 3-4 days after surgery)
Time to hospital discharge alive
Number of days alive in the hospital
Time frame: Hospital discharge (approximately 1-2 weeks after surgery)
Physical activity assessment
Katz activities of daily living (ADL) and Lawton Instrumental ADL (IADL)
Time frame: Screening (preoperative day -7 until day -1), day 30 follow-up, 3 and 6 months follow-up
Days alive and out of hospital
Time to be alive and discharge from hospital
Time frame: Day 30 follow-up, 3, 6, and 12 months follow-up
Time to discharge alive
Time to be alive and discharged from ICU/hospital
Time frame: ICU discharge (approximately 3-4 days after surgery), hospital discharge (approximately 1-2 weeks after surgery)
Weaning from cardiopulmonary bypass (CPB)
Number of attempts to wean from CPB during surgery
Time frame: Intraoperative day 0 (during surgery)
Persistent Organ Dysfunction + Death
Requiring supportive technologies during the convalescent phase of critical illness
Time frame: Postoperative days 0-7, ICU discharge (approximately 3-4 days after surgery), hospital discharge (approximately 1-2 weeks after surgery), day 30 follow-up
ICU Readmission rates
Readmission to ICU
Time frame: Day 30 follow-up, 3, 6, and 12 months follow-up
Hospital Readmission rates
Readmission to hospital
Time frame: Day 30 follow-up, 3, 6, and 12 months follow-up
Optional tertiary endpoint: Ultrasound measurement of thigh skeletal muscle mass
Ultrasound measurement of thigh skeletal muscle mass
Time frame: Screening (preoperative day -7 until day -1), ICU discharge (approximately 3-4 days after surgery), hospital discharge (approximately 1-2 weeks after surgery)
Optional tertiary endpoint: Functional Status Score for Intensive Care Unit (FSS-ICU)
Functional Status Score for Intensive Care Unit (FSS-ICU)
Time frame: Screening (preoperative day -7 until day -1), ICU discharge (approximately 3-4 days after surgery), hospital discharge (approximately 1-2 weeks after surgery)
Optional tertiary endpoint: Short Physical Performance Battery test (SPPB)
Short Physical Performance Battery test (SPPB)
Time frame: Screening (preoperative day -7 until day -1), ICU discharge (approximately 3-4 days after surgery), hospital discharge (approximately 1-2 weeks after surgery)
Optional tertiary endpoint: Hand grip/held dynamometer
Hand grip/held dynamometer
Time frame: Screening (preoperative day -7 until day -1), ICU discharge (approximately 3-4 days after surgery), hospital discharge (approximately 1-2 weeks after surgery)
Optional tertiary endpoint: Inflammatory response
Inflammatory response and immune function (measured by markers of the clinical routine (e.g. interleukin \[IL-\] -6, IL-1β, IL-2, IL-15, interferon \[IFN\] -γ, monocyte chemotactic protein \[MCP\] -1, Ferritin, D-Dimer , IL-10, C-reactive protein \[CRP\], white blood cell count \[WBC\], procalcitonin \[PCT\], tumor necrosis factor-α \[TNF-α\]).
Time frame: Intraoperative day 0, postoperative days 0-7
Optional tertiary endpoint: Left ventricular ejection fraction
Left ventricular ejection fractLeft ventricular ejection fractionion
Time frame: Preoperative day -1, hospital discharge (approximately 1-2 weeks after surgery), day 30 follow-up, 3 and 6 months follow-up
Optional tertiary endpoint: Manual Muscle Testing (MMT)
Manual Muscle Testing (MMT)
Time frame: Screening (preoperative day -7 until day -1), ICU discharge (approximately 3-4 days after surgery), hospital discharge (approximately 1-2 weeks after surgery)
Optional tertiary endpoint: Vasoactive-Inotropic Score (VIS)
Vasoactive-Inotropic Score (VIS)
Time frame: Postoperative days 0-7
Optional tertiary endpoint: Therapeutic Intervention Scoring System (TISS)
A method for measuring workload and calculating costs in the ICU
Time frame: Postoperative days 0-7
Optional tertiary endpoint: Development of delirium
Assessed by the CAM ICU score
Time frame: Postoperative days 0-7
Optional tertiary endpoint: Hemodynamic parameters
Adequate hemodynamic support, as defined by stable Cardiac Index, cardiac output (CO), Cardiac Power Index, mean arterial pressure (MAP), central vein pressure (CVP), pulmonary artery diastolic pressure (to be measured every 8 hours for first 72 hours post-op or until removal of pulmonary artery catheter, whatever comes first
Time frame: Intraoperative day 0, postoperative days 0-7
Optional tertiary endpoint: Clinical frailty scale
A 9-point scale that quantifies frailty based on function in individual patients
Time frame: Screening (preoperative day -1 until day -7), day 30 follow-up, 3 months follow-up
Optional tertiary endpoint: Simplified Acute Physiology Score (SAPS)
Estimates the probability of mortality for ICU patients on admission
Time frame: Postoperative days 0-7
Optional tertiary endpoints: Further routine biomarkers
Further routine biomarkers: creatinine, urea, bilirubin, troponin, triglycerides if available
Time frame: Intraoperative day 0, postoperative days 0-7
Separate Sub-study
Serial blood samples and - if available - tissue samples from patients (if these result from the routine surgical procedure) will be collected in concerning patients at the day before (only blood samples), during surgery (only tissue sample if available), and once daily after surgery while the patients are on ICU (only blood samples): * Specialized pro-resolving mediators (SPMs) and more specific markers of the inflammatory response, such as the production of leukotriene B5 (LTB5), leukotriene B4 (LTB4), 5-hydroxyeicosapentaenoic acid (5-HEPE) and production of 5-hydroxyeicosatetraenoic acid (5-HETE) * SPMs, such as maserins and resolvins * Oxidative stress (oxidative reduction potential, Malondialdehyde) * Membrane incorporation of PUFAs (white blood cells) \& tissue samples * Activation of survival kinases (such as extracellular-signal regulated
Time frame: Preoperative day -1, intraoperative day 0, postoperative days 0-7, hospital discharge (approximately 1-2 weeks after surgery)
Plan to share: No
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Studies of the drug tested here: Fish Oils
GCP-Service International West GmbH