Intravenous Fish Oil Based Lipid Emulsion to Enhance Recovery in High-Risk Cardiac Surgery Patients
Recruiting · NCT06279793 · Interventional (participants receive a specific treatment) · Lead sponsor: GCP-Service International West GmbH
View the official record on ClinicalTrials.gov →Interventions studied
Fish OilIntravenous 0.9% Sodium Chloride
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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%
Exclusion criteria
- 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 any other interventional trial will be discussed with the coordinating investigator on a case-by-case scenario and requires sponsor approval before inclusion
- Already receiving special FO-enriched 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
Where it is running
10 locations listed.
- 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