Phase II Study of Intravenous Fish Oil Lipid Emulsion to Reduce Postoperative Atrial Fibrillation and Improve Recovery in High-Risk Cardiac Surgery Patients

What this Trial Is About

Researchers are conducting the MODIFY CSX study, a prospective, randomized, placebo-controlled trial, to evaluate the effect of intravenous fish oil lipid emulsion on recovery in high-risk adult patients undergoing cardiac surgery. The study aims to reduce the occurrence of postoperative atrial fibrillation, which could lead to shorter hospital stays and improved mid- and long-term patient outcomes while potentially lowering healthcare costs. Participants will be randomly assigned to receive either fish oil at a dose of 0.20 g per kilogram of body weight per day approximately 2 mL of Omegaven per kilogram per day or a placebo of 0.9% sodium chloride in the same volume, alongside standard care. The fish oil treatment starts 24 to 3 hours before surgery as a 3-6 hour infusion, continues on postoperative day 0, and then daily for up to 7 days or until ICU discharge or death, whichever comes first. Participants will be monitored closely during their ICU stay and hospital admission, with follow-up visits scheduled at 30 days, 3 months, 6 months, and 12 months after surgery. Assessments include tracking the onset of atrial fibrillation, mechanical ventilation use, organ function scores, stroke occurrence, kidney injury, infection rates, survival status, quality of life, physical activity, hospital readmission rates, and other health outcomes. Safety monitoring continues throughout the study period, which may last up to one year after surgery.

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