Intravenous Fish Oil based Lipid Emulsion to enhance recovery in High-Risk Cardiac Surgery Patients: a phase II multicenter trial (MODIFY CSX)
EU CT Number: 2023-503490-38
Steering Committee: Christian Stoppe, Gunnar Elke, Markus Velten, Ellen Dresen
Study Objectives
Primary: to demonstrate superiority of fish oil (FO) compared to placebo in the prevention of atrial fibrillation (AF) until 7 days after surgery. This clinical endpoint is assessed as part of the clinical practice.
Secondary: to investigate the effect of FO on recovery after cardiac surgery compared to placebo.
Study population: High risk patients requiring complex cardiac surgery and prolonged intensive care unit (ICU) length of stay.