Intravenous Fish Oil for Critically Ill Patients with High Inflammation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The FOiL-INFLAMe trial is a Phase 2 randomized study comparing two doses of intravenous fish oil emulsion plus usual care versus usual care alone in 159 adults with critical illness and high inflammation. Participants have elevated IL-6, require respiratory support, and are expected to stay in the ICU for several days. The trial aims to determine safety and how the two doses affect inflammatory markers, organ function, muscle mass, physical function, and clinical outcomes to inform a next larger trial. Omegaven 10% fish-oil emulsion is the investigational product used in the intervention arms.

Why it matters

Who can join: the full rules

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

Where it's running

• Faculty of Medicine, University of Malaya
  Kuala Lumpur, Kuala Lumpur, Malaysia Recruiting

Study contacts

• Principal investigator: Zheng Yii Lee, PhD — University of Malaya
• Study coordinator: Zheng Yii Lee, PhD
• Email: zheng_yii@hotmail.com
• Phone: +60169754153

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.