RECRUITING Phase 2 ClinicalTrials.gov

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

Sponsor: Lee Zheng Yii • ClinicalTrials.gov ID: NCT07883447

Registry updated: 2026-10-20

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Description

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.

Interventions

Omegaven (10% fish-oil emulsion; Fresenius-Kabi) (Drug)
Omegaven 10% intravenous fish-oil lipid emulsion

Eligibility criteria

Inclusion Criteria: * Adult (age ≥18) * Patients requiring oxygen support (mechanical ventilation, non-invasive ventilation or high flow nasal cannula) and expected to require the oxygen support for another 48 hours from randomization * Expected intensive care unit (ICU) stay for ≥72 hours from randomization * Patients on exclusive enteral nutrition (EN) * High inflammatory status (Interleukin-6 \>100 pg/mL) Exclusion Criteria: * Stayed more than 24 hours in the ICU * Elective surgical patients in the ICU for monitoring * Moribund * Pregnant or lactating * Known hypersensitivity to fish or egg protein or to any of the active ingredients or excipients * Severe coagulation abnormalities (International Normalized Ratio \[INR\]\>2.4), platelet \<50 x 10\^9/L or active bleeding * Severe hyperlipidemia or severe disorders of lipid metabolism with serum triglycerides level \>11.29 mmol/L * Taking fish oil supplements in the past 1 month * Patients with ongoing or expected to start extracorporeal blood purification * High-dose fish oil deemed clinically inappropriate for the patient's condition by the treating clinician

Conditions

Critical Illness

Locations

Faculty of Medicine, University of Malaya — Kuala Lumpur, Kuala Lumpur, Malaysia

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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