Clinical Research Directory

Intravenous Fish Oil Emulsion in Critically Ill Patients With High Inflammatory Status.

Sponsor: Lee Zheng Yii

Summary

Critically ill patients can develop high levels of inflammation, which may contribute to organ damage, muscle loss, and difficulty recovering physical function. Fish oil contains omega-3 fatty acids that may help reduce inflammation. However, the most suitable dose of fish oil given intravenously (directly into a vein) in critically ill patients with high levels of inflammation is uncertain. The FOiL-INFLAMe trial is a phase II study comparing two doses of intravenous fish oil with usual care. Its main purpose is to determine their effects on inflammation and assess their safety, to help select a dose for a larger trial. The study will also examine organ function, muscle mass, physical function, and clinical outcomes. The study will enrol 159 critically ill adults who require breathing support, receive nutrition through a feeding tube, and have high blood levels of interleukin-6 (IL-6), a marker of inflammation. Participants will be assigned by chance to one of three groups: (i) Lower-dose fish oil: 0.2 grams per kilogram of body weight per day. (ii) Higher-dose fish oil: 0.4 grams per kilogram of body weight per day. (iii) Usual care without additional intravenous fish oil. All groups will receive usual intensive care and nutritional support. In the fish oil groups, treatment will begin within six hours of group assignment and will be given intravenously over eight hours each day, for up to seven days while in the intensive care unit. The main outcome is the change in blood IL-6 levels from day 1 to day 4. We will also measure other blood markers, assess organ function, use ultrasound to measure thigh muscle size, and assess handgrip strength and short physical performance battery test. Other outcomes include survival, time on mechanical ventilation, and length of intensive care and hospital stay. Participants will be monitored for potential side effects throughout treatment.

Official title: The Effect of Intravenous Fish Oil Emulsion on Inflammatory Markers, Organ Function, Muscle Mass, Physical Function, and Clinical Outcomes in Critically Ill Patients With High Inflammatory Status. A Phase II, Single-blind, Dose-finding, Randomized Controlled Trial

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