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

Phase 2

Recruiting

• Conditions: 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
• Interventions: Drug: Fish Oil; Drug: Intravenous 0.9% Sodium Chloride

• Registration Number: NCT06279793
• Lead Sponsor: GCP-Service International West GmbH

Brief Summary

The MODIFY CSX study is a prospective, randomized, placebo-controlled trial conducted in heart centers in Germany.

A total of 120 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.

Detailed Description

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 be the onset and occurence of atrial fibrillation after cardiac surgery (AFACS) until day 7 after surgery (on ICU and normal ward).

Study Timeline

• Study First Submitted: 2023-09-13
• Study Start: 2024-02-15
• Study First Submitted QC: 2024-02-19
• Study First Posted: 2024-02-28
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-28
• Last Update Posted: 2025-04-30
• Primary Completion: 2026-02
• Study Completion: 2027-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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 anyinterventional trial within the last 30 days
10. Already receiving FO-containing 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment group	Fish Oil	Patients will receive 0.20 g fish oil/kg BW/d (≙2 mL Omegaven®/kg BW/d).
Control group	Intravenous 0.9% Sodium Chloride	Patients will receive 0,9% NaCl in volume 2 mL/kg BW/d (placebo).

Primary Outcome Measures

Name	Time	Method
Atrial fibrillation	Postoperative days 0-7	The primary objective is to demonstrate superiority of fish oil compared to placebo in the prevention of atrial fibrillation until 7 days after surgery. This clinical endpoint is assessed as part of the clinical practice.

Secondary Outcome Measures

Name	Time	Method
Adverse Events	Preoperative day -1 to 12 months follow-up	AEs leading to discontinuation/AEs at least possibly related to the IMP/SAEs
Stroke	Postoperative days 0-7	Incidence of stroke
Postoperative bleeding	Postoperative days 0-7	Bleeding after surgery
Hospital length of stay	Hospital discharge (approximately 1-2 weeks after surgery)	Number of days alive in the hospital
Physical activity assessment	Screening (preoperative day -7 until day -1), day 30 follow-up, 3 and 6 months follow-up	Katz activities of daily living (ADL) and Lawton's Instrumental ADL (IADL)
Days alive and out of hospital	Day 30 follow-up, 3, 6, and 12 months follow-up	Time to be alive and discharge from hospital
Time to discharge alive	ICU discharge (approximately 3-4 days after surgery), hospital discharge (approximately 1-2 weeks after surgery)	Time to be alive and discharged from ICU/hospital
Weaning from cardiopulmonary bypass (CPB)	Intraoperative day 0 (during surgery)	Number of attempts to wean from CPB during surgery
Acute Kidney Injury	Postoperative days 0-7	Kidney Disease: Improving Global Outcomes \[KDIGO\] stages 1-3
Infection rate	Postoperative days 0-7	Number of infections
ICU length of stay	ICU discharge (approximately 3-4 days after surgery)	Number of days alive in the ICU
Quality of Life (SF-36)	Screening (preoperative day -7 until day -1), day 30 follow-up, 3, 6, and 12 months follow-up	To measure the quality of life
Hospital Readmission rates	Day 30 follow-up, 3, 6, and 12 months follow-up	Readmission to hospital
Mechanical ventilation	Postoperative days 0-7, ICU discharge (approximately 3-4 days after surgery), hospital discharge (approximately 1-2 weeks after surgery), day 30 follow-up	Duration of mechanical ventilation
Delta Sequential Organ Failure Assessment Score (SOFA) Score	Postoperative days 0-7	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.
Inotropics/vasopressors	Postoperative days 0-7, ICU discharge (approximately 3-4 days after surgery), hospital discharge (approximately 1-2 weeks after surgery), day 30 follow-up	Duration of inotropic/vasopressor support
Survival status	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	Overall survival
Persistent Organ Dysfunction + Death	Postoperative days 0-7, ICU discharge (approximately 3-4 days after surgery), hospital discharge (approximately 1-2 weeks after surgery), day 30 follow-up	Requiring supportive technologies during the convalescent phase of critical illness
ICU Readmission rates	Day 30 follow-up, 3, 6, and 12 months follow-up	Readmission to ICU

Trial Locations

Locations (8)

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; 🇩🇪 Muenster, Germany