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RECRUITING

NCT06279793

PHASE2

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

Sponsor: GCP-Service International West GmbH

View on ClinicalTrials.gov

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.

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 -

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

550

Start Date

2024-02-15

Completion Date

2030-09

Last Updated

2026-02-23

Healthy Volunteers

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

Interventions

DRUG

Fish Oil

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

DRUG

Intravenous 0.9% Sodium Chloride

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

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

Locations (10)

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

Münster, Germany

University Medical Center Rostock

Rostock, Germany

Robert Bosch Medical Center

Stuttgart, Germany