Intravenous Fish Oil Based Lipid Emulsion to Enhance Recovery in High-Risk Cardiac Surgery Patients: a Phase II Multicenter Randomized, Placebo-Controlled Trial

What this Trial Is About

The MODIFY CSX study is a prospective, randomized, placebo-controlled trial evaluating intravenous fish oil lipid emulsion in high-risk adult patients undergoing elective cardiac surgery with cardiopulmonary bypass. The study aims to reduce the occurrence of postoperative atrial fibrillation and improve recovery times, potentially leading to better mid and long-term outcomes and lower healthcare costs. This Phase II multicenter trial is conducted in heart centers in Germany and Italy and involves 550 participants. Participants are randomly assigned to receive either 0.20 g fish oil per kg body weight per day (Omegaven®) or a placebo of 0.9% sodium chloride at the same volume, both alongside standard care. The fish oil treatment starts 24 to 3 hours before surgery and continues daily until ICU discharge, death, or postoperative day 7, whichever comes first. The control group receives the placebo infusion on the same schedule. Follow-up assessments occur at day 30 and at 3, 6, and 12 months after surgery. During the study, participants undergo monitoring for atrial fibrillation and related arrhythmias during the first 7 days after surgery, both in ICU and on the normal ward. Additional evaluations include mechanical ventilation duration, organ function scores, stroke incidence, infections, survival status, quality of life, physical activity, bleeding, ICU and hospital stays, and readmission rates. Safety is tracked through adverse events from before surgery until 12 months postoperatively, with multiple follow-up timepoints to assess long-term outcomes and recovery.

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