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Clinical Trials in Germany / NCT06279793
Recruiting Phase 2

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

NCT06279793 · tracked via the Priya Life Science Germany tracker
Phase
Phase 2
Started
2024-02-15
Last updated
2026-07-08

Condition(s) studied

Intensive Care UnitCoronary Artery Bypass Grafting (CABG)High Risk PatientsCardiopulmonary BypassElective Cardiac SurgeryValvular Heart SurgeryMultiple Valve SurgeriesCombined Cardiac ProceduresAortic Surgical ProceduresAdult Patients ≥ 18 YearsCombined Valve and CABGCombined Cardiac and Aortic Surgical Procedures

Investigational drug(s) / intervention(s)

Fish OilIntravenous 0.9% Sodium Chloride

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

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
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

Primary outcome measure(s)

Trial sites (10)

FacilityCityRegionStatus
University Hospital Augsburg Augsburg Germany 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 Recruiting

More GCP-Service International West GmbH trials in Germany

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06279793 on ClinicalTrials.gov ↗ ← All trials in Germany