Intravenous Fish Oil Based Lipid Emulsion to Enhance Recovery in High-Risk Cardiac Surgery Patients (NCT06279793) | Clinical Trial Compass
RecruitingPhase 2
Intravenous Fish Oil Based Lipid Emulsion to Enhance Recovery in High-Risk Cardiac Surgery Patients
Germany550 participantsStarted 2024-02-15
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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