A Phase 2 interventional study of Omegaven (10% fish-oil emulsion; Fresenius-Kabi) in Critical Illness, sponsored by Lee Zheng Yii. Recruiting at 1 site in Malaysia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by Lee Zheng Yii · Phase 2, Interventional, and Treatment
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.
1,923 studies on the registry are indexed under Critical Illness; 465 are open to participants now.
This study's planned enrollment of 159 is above the median of 90 across 1,003 interventional studies indexed under Critical Illness.
Browse Critical Illness studies →This is the only study on the registry with Lee Zheng Yii as lead sponsor.
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Exclusion Criteria:
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)
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 without additional intravenous fish oil.
Omegaven 10% intravenous fish-oil lipid emulsion
Also known as: Fish oil triglycerides; intravenous fish-oil lipid emulsion
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.
Time frame: Day 1 (before intervention) and Day 4 after randomization
Area under the blood IL-6 concentration-time curve from Day 1 through Day 4
The area under the curve will be calculated from blood IL-6 concentrations obtained from Day 1 before intervention through Day 4.
Time frame: Day 1 (before intervention), and day 2, 3 and 4 after randomization
Change in blood IL-6 concentration from Day 1 to Day 7
Blood IL-6 concentration will be measured on Day 1 before the intervention and on Day 7. Change will be calculated as the Day 7 value minus the Day 1 value.
Time frame: 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
Blood CRP concentration will be measured on Days 1, 4, and 7. Changes at Days 4 and 7 will each be calculated by subtracting the Day 1 value.
Time frame: 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
Blood IL-10 concentration will be measured on Days 1, 4, and 7. Changes at Days 4 and 7 will each be calculated by subtracting the Day 1 value.
Time frame: Day 1 (before intervention), Day 4, and Day 7 after randomization
Change in blood procalcitonin concentration from Day 1 to Days 4 and 7
Blood procalcitonin concentration will be measured on Days 1, 4, and 7. Changes at Days 4 and 7 will each be calculated by subtracting the Day 1 value.
Time frame: Day 1 (before intervention), Day 4, and Day 7 after randomization
Change in Sequential Organ Failure Assessment (SOFA) score from Day 1 to Days 4 and 7
The SOFA score assesses dysfunction across six organ systems. Total scores range from 0 to 24; higher scores indicate greater organ dysfunction. Changes at Days 4 and 7 will each be calculated by subtracting the Day 1 score.
Time frame: Day 1 (before intervention), Day 4, and Day 7 after randomization
Blood concentrations of 58 lipid mediators
Concentrations of the 58 prespecified lipid mediators. The lipid mediators are listed in Table 2 of Hartling et al. Clin Chem Lab Med. 2021;59(11):1811-1823. doi:10.1515/cclm-2021-0644
Time frame: Day 1 (before intervention), Day 4, and Day 7 after randomization
Red blood cell eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) levels
EPA and DHA levels in red blood cells will be measured and reported separately.
Time frame: Day 1 (before intervention), Day 4, and Day 7 after randomization
Rectus femoris cross-sectional area measured by ultrasound
Ultrasound will be used to measure the cross-sectional area (cm2) of the rectus femoris muscle at each assessment
Time frame: Day 1 (before intervention); Day 7 or ICU discharge (whichever comes first); and Day 28 or hospital discharge (whichever comes first) after randomization
Quadriceps muscle layer thickness measured by ultrasound
Ultrasound will be used to measure quadriceps muscle layer thickness (cm) at each assessment.
Time frame: Day 1 (before intervention); Day 7 or ICU discharge (whichever comes first); and Day 28 or hospital discharge (whichever comes first) after randomization
Number of participants who died in the ICU, in the hospital, by Day 28, and by Day 60
All-cause deaths will be counted separately during the ICU stay, during the hospital stay, by Day 28, and by Day 60 after randomization.
Time frame: During the ICU and hospital stays, each up to Day 60 after randomization; and by Days 28 and 60 after randomization
Intensive care unit (ICU) length of stay
Number of days from ICU admission until ICU discharge or death, assessed up to Day 60 after randomization.
Time frame: From ICU admission until ICU discharge or death, up to Day 60 after randomization
Hospital length of stay
Number of days from hospital admission until hospital discharge or death, assessed up to Day 60 after randomization.
Time frame: From hospital admission until hospital discharge or death, up to Day 60 after randomization
Duration of Mechanical Ventilation
Total number of days receiving invasive mechanical ventilation from ICU admission during the assessment period. Days from separate episodes will be summed.
Time frame: From ICU admission until hospital discharge, death, or Day 60 after randomization, whichever occurs first
Day 28 persistent organ dysfunction or death
Participants will be counted if they die by Day 28 or, if alive on Day 28, still require at least one of the following: vasopressors or inotropes, mechanical circulatory support, dialysis, or mechanical ventilation.
Time frame: From randomization through Day 28 for death; on Day 28 after randomization for ongoing organ support
Handgrip strength measured with a handgrip dynamometer
Handgrip strength will be measured using a handgrip dynamometer and reported as the measured grip force in kilogram
Time frame: At ICU discharge and hospital discharge, with each assessment occurring no later than Day 28 after randomization
Knee extension strength measured with MicroFET2 Handheld dynamometer
Knee extension strength will be measured using a MicroFET2 Handheld dynamometer and reported in kilogram
Time frame: At hospital discharge, or on Day 28 after randomization if the participant remains hospitalized
Medical Research Council sum score for muscle strength
Strength in six muscle groups on each side of the body is graded from 0 to 5 and summed. The total score ranges from 0 to 60; higher scores indicate greater muscle strength.
Time frame: Before hospital discharge, up to Day 28 after randomization
Short Physical Performance Battery (SPPB) total score
The SPPB assesses standing balance, usual gait speed, and repeated chair stands. Each component is scored from 0 to 4; the total score ranges from 0 to 12, with higher scores indicating better physical performance.
Time frame: Before hospital discharge, up to Day 28 after randomization
Number of participants with hypertriglyceridemia during the intervention period
Count participants with at least one blood triglyceride concentration greater than 3.0 mmol/L during the intervention period. Assessment begins when the intervention starts, or 6 hours after randomization for the control group.
Time frame: 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
Count participants with at least one new bleeding event documented during the intervention period. Assessment begins when the intervention starts, or 6 hours after randomization for the control group.
Time frame: 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
Count participants with at least one newly documented episode of atrial fibrillation during the intervention period. Assessment begins when the intervention starts, or 6 hours after randomization for the control group.
Time frame: 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
EQ-5D-5L health utility index
Among participants alive at each assessment, the five-dimension, five-level EuroQol questionnaire (EQ-5D-5L) will be administered by telephone.
Time frame: At 3, 6, and 12 months after randomization
EQ-5D-5L visual analogue scale (EQ VAS) score
Among participants alive at each assessment, the EQ VAS will be administered by telephone. Scores range from 0 (worst health imaginable) to 100 (best health imaginable); higher scores indicate better self-rated health.
Time frame: At 3, 6, and 12 months after randomization
Katz Activities of Daily Living (ADL)
Among survivors, Katz ADL, interviewed via telephone
Time frame: At 3, 6, and 12 months after randomization
Lawton Instrumental Activities of Daily Living (IADL)
Among survivors, Lawton IADL, interview via telephone
Time frame: At 3, 6, and 12 months after randomization
Plan to share: Undecided
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Studies of the drug tested here: Fish oil triglycerides