> Trialight public data. Index of pages: https://trialight.com/llms.txt
> Web page: https://trialight.com/data/trial/intravenous-fish-oil-based-lipid-emulsion-to-enhance-2fcf8c2c-5bd4-487f-abd9-911c4613d467
> Record changed: 2026-10-13

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

NCT06279793

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06279793)

Phase

Phase 2

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06279793)

Recruitment status

Recruiting

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06279793)

Participants

550

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06279793)

Lead sponsor

GCP-Service International West GmbH

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06279793)

Start date

2024-02-15

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06279793)

Number of sites

10

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06279793)

## Title and summary

**Summary**

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.

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06279793)

**Acronym**

MODIFY CSX

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06279793)

**Short title**

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

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06279793)

**Official title**

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](https://clinicaltrials.gov/study/NCT06279793)

## Status and phase

**Control arm**

Placebo

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06279793)

**Registry reports results**

No

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06279793)

**Listing at source**

Listed

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06279793)

**Recruitment status**

Recruiting

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06279793)

**Phase**

Phase 2

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06279793)

**Study type**

Interventional

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06279793)

## Dates

**Completion date**

2030-09-01

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06279793)

**First posted**

2024-02-28

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06279793)

**Registry last updated**

2026-07-08

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06279793)

**Primary completion date**

2030-03-01

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06279793)

**Start date**

2024-02-15

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06279793)

## Size and sites

**Participants**

550

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06279793)

**Participant count basis**

Estimated

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06279793)

**Planned participants**

550

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06279793)

**Protocol amendments**

4

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06279793)

**Number of sites**

10

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06279793)

## Sponsor and oversight

**Data monitoring committee**

No

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06279793)

**Registry sponsor category**

Industry

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06279793)

**Lead sponsor**

GCP-Service International West GmbH

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06279793)

**Source registry**

ClinicalTrials.gov

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06279793)

## Identifiers

**Registry ID**

NCT06279793

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06279793)

**ClinicalTrials.gov ID**

NCT06279793

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06279793)

**Registry record**

Open registry record

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06279793)

## Study design

**Allocation**

Randomised

**Model**

Parallel groups

**Purpose**

Prevention

**Masking**

Triple masking

**Masking description**

Patients as well as clinical staff and outcome assessors not involved in the study will be blinded to study intervention allocation.

**Masked roles**

Participants, Care providers, Outcome assessors

Sources for study design

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06279793)

## Outcomes

### Primary outcomes

1. Atrial fibrillation  
Timeframe: Postoperative days 0-7  
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.

### Secondary outcomes

1. Mechanical ventilation  
Timeframe: 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
2. Adverse Events  
Timeframe: Preoperative day -1 to 12 months follow-up  
AEs leading to discontinuation/AEs at least possibly related to the IMP/SAEs
3. Delta Sequential Organ Failure Assessment Score (SOFA) Score  
Timeframe: 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.
4. Stroke  
Timeframe: Postoperative days 0-7  
Incidence of stroke
5. Inotropics/vasopressors  
Timeframe: 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
6. Acute Kidney Injury  
Timeframe: Postoperative days 0-7  
Kidney Disease: Improving Global Outcomes \\\[KDIGO\\\] stages 1-3
7. Infection rate  
Timeframe: Postoperative days 0-7  
Number of infections
8. Survival status  
Timeframe: 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
9. Quality of Life (SF-36)  
Timeframe: Screening (preoperative day -7 until day -1), day 30 follow-up, 3, 6, and 12 months follow-up  
To measure the quality of life
10. Postoperative bleeding  
Timeframe: Postoperative days 0-7  
Bleeding after surgery
11. Time to ICU discharge alive  
Timeframe: ICU discharge (approximately 3-4 days after surgery)  
Number of days alive in the ICU
12. Time to hospital discharge alive  
Timeframe: Hospital discharge (approximately 1-2 weeks after surgery)  
Number of days alive in the hospital
13. Physical activity assessment  
Timeframe: 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 Instrumental ADL (IADL)
14. Days alive and out of hospital  
Timeframe: Day 30 follow-up, 3, 6, and 12 months follow-up  
Time to be alive and discharge from hospital
15. Time to discharge alive  
Timeframe: 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
16. Weaning from cardiopulmonary bypass (CPB)  
Timeframe: Intraoperative day 0 (during surgery)  
Number of attempts to wean from CPB during surgery
17. Persistent Organ Dysfunction + Death  
Timeframe: 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
18. ICU Readmission rates  
Timeframe: Day 30 follow-up, 3, 6, and 12 months follow-up  
Readmission to ICU
19. Hospital Readmission rates  
Timeframe: Day 30 follow-up, 3, 6, and 12 months follow-up  
Readmission to hospital

Sources for outcomes

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06279793)

## Eligibility

**Sex**

All

**Age groups**

Adults, Older adults

**Minimum age**

18 Years

**Healthy volunteers**

No

### 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

Sources for eligibility

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06279793)

## Sites

- University Hospital AugsburgAugsburg, GermanyRecruiting
- Charité Universitätsmedizin BerlinBerlin, GermanyRecruiting
- University of BonnBonn, GermanyRecruiting
- University Hospital GoettingenGöttingen, GermanyRecruiting
- University Hospital Hamburg-EppendorfHamburg, GermanyRecruiting
- University Medical Center Schleswig-HolsteinKiel, GermanyRecruiting
- University Hospital MainzMainz, GermanyRecruiting
- University Hospital MuensterMünster, GermanyRecruiting
- University Medical Center RostockRostock, GermanyNot yet recruiting
- Robert Bosch Medical CenterStuttgart, GermanyRecruiting

Sources for sites

Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06279793)

## Related records

### Drugs (1)

- [FISH OIL](https://trialight.com/data/asset/fish-oil-ad06c0e1-eb05-4af3-8ddc-aeba0adf11fd.md)

### Collaborators (11)

- Charite University, Berlin, Germany
- Johannes Gutenberg University Mainz
- Robert Bosch-Krankenhaus Stuttgart
- Universitatsklinikum Hamburg-Eppendorf
- University Hospital Augsburg
- University Hospital Goettingen
- University Hospital Muenster
- University Hospital Schleswig-Holstein
- University Hospital, Bonn
- University Medical Center Rostock
- Wuerzburg University Hospital

### Lead sponsors (1)

- [GCP-Service International West GmbH](https://trialight.com/data/company/gcp-service-international-west-gmbh-459c9ada-d80f-464d-a019-663ec8f1705d.md)

### Conditions (2)

- [Atrial fibrillation](https://trialight.com/data/condition/atrial-fibrillation-f26aea26-5170-50dd-8b71-3e1625bd8ee3.md)
- [Atrial flutter](https://trialight.com/data/condition/atrial-flutter-3a0bf35e-55d4-56e7-a789-e5c7b7fd5dd8.md)

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