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

NCT06279793 | Recruiting Phase 2

• 1 other identifier: MODIFY CSX
• Study Type: interventional
• Target: 550
• Locations: 1 country
• Sites: 10

Brief 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.

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; Adult Patients ≥ 18 Years; Combined Valve and CABG; Combined Cardiac and Aortic Surgical Procedures

Keywords

intensive care unit; elective cardiac surgery; fish oil; medical nutrition therapy; atrial fibrillation; atrial flutter; atrial tachycardia

Outcome Measures

Primary Outcomes (1)

• Atrial fibrillation

  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.

  Postoperative days 0-7

Secondary Outcomes (19)

• 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

• Adverse Events

  Preoperative day -1 to 12 months follow-up

• Delta Sequential Organ Failure Assessment Score (SOFA) Score

  Postoperative days 0-7

• Stroke

  Postoperative days 0-7

• 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

Other Outcomes (15)

• Optional tertiary endpoint: Ultrasound measurement of thigh skeletal muscle mass

  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)

  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)

  Screening (preoperative day -7 until day -1), ICU discharge (approximately 3-4 days after surgery), hospital discharge (approximately 1-2 weeks after surgery)

Study Arms (2)

Treatment group

EXPERIMENTAL

Patients will receive 0.20 g fish oil/kg BW/d (≙2 mL Omegaven®/kg BW/d).

Drug: Fish Oil

Control group

PLACEBO COMPARATOR

Patients will receive 0,9% NaCl in volume 2 mL/kg BW/d (placebo).

Drug: Intravenous 0.9% Sodium Chloride

Interventions

Fish Oil DRUG

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®

Treatment group

Intravenous 0.9% Sodium Chloride DRUG

Intravenous 0.9% Sodium Chloride (volume 2 mL/kg BW/d) provided at the same timepoints as the intervention.

Also known as: Saline Infusion

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• Known hypersensitivity to fish oil/fish products or egg protein
• Pregnancy or lactation period
• Previous history of chronic atrial fibrillation, atrial flutter and/or atrial tachyarrhythmia
• 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
• Patients receiving extracorporeal mechanical assist device (e.g. ECLS, or IABP) or advanced heart failure therapies (e.g. TAH, VAD)
• Enrolment in anyinterventional trial within the last 30 days
• Already receiving FO-containing medical nutrition products
• Severe malnutrition (as defined by the BMI \<18.5)
• Severe liver dysfunction defined by Child Pugh Class C.
• Severe chronic kidney dysfunction defined by the National Kidney Foundation (NKF) stage 4 and 5 by using the glomerular filtration rate (GFR \<30ml/min)
• Known severe coagulation disorder

Sponsors & Collaborators

• GCP-Service International West GmbH: lead
• University Hospital, Bonn: collaborator
• University Hospital Muenster: collaborator
• University Hospital Goettingen: collaborator
• University Hospital Schleswig-Holstein: collaborator
• Charite University, Berlin, Germany: collaborator
• Wuerzburg University Hospital: collaborator
• Johannes Gutenberg University Mainz: collaborator
• University Hospital Augsburg: collaborator
• Universitätsklinikum Hamburg-Eppendorf: collaborator
• University Medical Center Rostock: collaborator
• Robert Bosch Medical Center: collaborator

Study Sites (10)

University Hospital Augsburg

Augsburg, Germany

NOT YET RECRUITING

Charité Universitätsmedizin Berlin

Berlin, Germany

RECRUITING

University of Bonn

Bonn, Germany

RECRUITING

University Hospital Goettingen

Göttingen, Germany

RECRUITING

University Hospital Hamburg-Eppendorf

Hamburg, Germany

RECRUITING

University Medical Center Schleswig-Holstein

Kiel, Germany

RECRUITING

University Hospital Mainz

Mainz, Germany

RECRUITING

University Hospital Muenster

Münster, Germany

RECRUITING

University Medical Center Rostock

Rostock, Germany

NOT YET RECRUITING

Robert Bosch Medical Center

Stuttgart, Germany

NOT YET RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation; Atrial Flutter

Interventions

Fish Oils; fish oil triglycerides; Sodium Chloride

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Oils; Lipids; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Christian Stoppe, Prof. Dr.

  Wuerzburg University Hospital

  STUDY DIRECTOR

Central Study Contacts

Christian Stoppe, Prof. Dr.

CONTACT

49-931-20130001; cstoppe@gcp-service.com

Ellen Dresen, Dr.

CONTACT

+49 931-201 30392; Dresen_E@ukw.de

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Patients as well as clinical staff and outcome assessors not involved in the study will be blinded to study intervention allocation.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomization will be stratified by site, employing a web-based system using a 1:1 ratio to either intravenous fish oil-based lipid emulsion (Omegaven®), or placebo.

Study Record Dates

• First Submitted: September 13, 2023
• First Posted: February 28, 2024
• Study Start: February 15, 2024
• Primary Completion (Estimated): March 1, 2030
• Study Completion (Estimated): September 1, 2030
• Last Updated: February 23, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (10)