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

NCT07883447 | Recruiting Phase 2

• 2 other identifiers: MREC ID NO 202364-12529NMRR ID-23-02860-POQ
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Critical Illness

Keywords

nutrition; fish oil; critical illness; intensive care

Outcome Measures

Primary Outcomes (1)

• Change in blood interleukin-6 (IL-6) concentration from Day 1 to Day 4

  Blood IL-6 concentration will be measured on Day 1 before the intervention and on Day 4. Change will be calculated as the Day 4 value minus the Day 1 value.

  Day 1 (before intervention) and Day 4 after randomization

Secondary Outcomes (19)

• Area under the blood IL-6 concentration-time curve from Day 1 through Day 4

  Day 1 (before intervention), and day 2, 3 and 4 after randomization

• Change in blood IL-6 concentration from Day 1 to Day 7

  Day 1 (before intervention) and Day 7 after randomization

• Change in blood C-reactive protein (CRP) concentration from Day 1 to Days 4 and 7

  Day 1 (before intervention), Day 4, and Day 7 after randomization

• Change in blood interleukin-10 (IL-10) concentration from Day 1 to Days 4 and 7

  Day 1 (before intervention), Day 4, and Day 7 after randomization

• Change in blood procalcitonin concentration from Day 1 to Days 4 and 7

  Day 1 (before intervention), Day 4, and Day 7 after randomization

Other Outcomes (7)

• Number of participants with hypertriglyceridemia during the intervention period

  Daily from the start of intervention, or 6 hours after randomization for the control group, through Day 7 after randomization or ICU discharge, whichever occurs first

• Number of participants with at least one new bleeding event during the intervention period

  From the start of intervention, or 6 hours after randomization for the control group, through Day 7 after randomization or ICU discharge, whichever occurs first

• Number of participants with new atrial fibrillation during the intervention period

  From the start of intervention, or 6 hours after randomization for the control group, through Day 7 after randomization or ICU discharge, whichever occurs first

Study Arms (3)

High-dose fish oil

EXPERIMENTAL

0.4 grams per kilogram of body weight per day, given intravenously over 8 hours, daily for up to 7 days post-randomization in the ICU

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

Low-dose fish oil

EXPERIMENTAL

0.2 grams per kilogram of body weight per day, given intravenously over 8 hours, daily for up to 7 days post-randomization in the ICU

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

Usual Care

NO INTERVENTION

Usual care without additional intravenous fish oil.

Interventions

Omegaven (10% fish-oil emulsion; Fresenius-Kabi) DRUG

Omegaven 10% intravenous fish-oil lipid emulsion

Also known as: Fish oil triglycerides; intravenous fish-oil lipid emulsion

High-dose fish oil; Low-dose fish oil

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Lee Zheng Yii: lead
• Fresenius Kabi: collaborator

Study Sites (1)

Faculty of Medicine, University of Malaya

Kuala Lumpur, Kuala Lumpur, 50603, Malaysia

RECRUITING

MeSH Terms

Conditions

Critical Illness

Interventions

fish oil triglycerides

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Zheng Yii Lee, PhD

  University of Malaya

  PRINCIPAL INVESTIGATOR

• Shahnaz Hasan

  University of Malaya

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zheng Yii Lee, PhD

CONTACT

+60169754153; zheng_yii@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Data analyst
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 22, 2026
• First Posted: October 20, 2026
• Study Start: July 7, 2026
• Primary Completion (Estimated): July 7, 2028
• Study Completion (Estimated): July 7, 2029
• Last Updated: October 20, 2026

Record last verified: 2026-10

Locations

MY (1)