Critical IllnessPhase 2FOiL-INFLAMeNCT07883447
Intravenous Fish Oil Emulsion in Critically Ill Patients With High Inflammatory Status.
A Phase 2 study testing Omegaven (10% fish-oil emulsion; Fresenius-Kabi) in people with Critical Illness, run by Lee Zheng Yii at 1 site in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness
- What is being tested?
- Omegaven (10% fish-oil emulsion; Fresenius-Kabi)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- 1 siteMalaysia
- Study dates
- 7 Jul 2026to 7 Jul 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Malaysia1 site, 1 recruiting
- Recruiting
Faculty of Medicine, University of Malaya
Kuala Lumpur, Kuala Lumpur, 50603
Zheng Yii Lee, PhD, +60169754153, zheng_yii@hotmail.com
Zheng Yii Lee, zheng_yii@hotmail.com
About this study
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
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.
Read more
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
- Being tested
- Omegaven (10% fish-oil emulsion; Fresenius-Kabi)
- Keywords
- nutrition, fish oil, critical illness, intensive care
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omegaven (10% fish-oil emulsion; Fresenius-Kabi)Drug
Also called Fish oil triglycerides; intravenous fish-oil lipid emulsion
Omegaven 10% intravenous fish-oil lipid emulsion
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Omegaven (10% fish-oil emulsion; Fresenius-Kabi) |
| Usual Care | No intervention | Usual care without additional intravenous fish oil. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
The area under the curve will be calculated from blood IL-6 concentrations obtained from Day 1 before intervention through Day 4.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: Before hospital discharge, up to Day 28 after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study start7 Jul 2026
- Primary completion7 Jul 2028 (estimated)
- Study completion7 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 159 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lee Zheng Yii
- Sponsor type
- University, hospital or other
- Collaborators
- Fresenius Kabi
- Responsible party
- Sponsor-investigator, Lee Zheng Yii, University of Malaya
- Investigators
- Zheng Yii Lee, PhD, Principal investigator, University of MalayaShahnaz Hasan, Principal investigator, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07883447
- Sponsor's protocol ID
- MREC ID NO 202364-12529
- Other IDs
- NMRR ID-23-02860-POQ
- Acronym
- FOiL-INFLAMe
- Status last verified
- Oct 2026
- First submitted
- 22 Sep 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07883447
- Acronym / sponsor ID
- FOiL-INFLAMe / MREC ID NO 202364-12529
- Conditions
- Critical Illness
- Keywords
- nutrition, fish oil, critical illness, intensive care
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 159 participants (estimated)
- Lead sponsor
- Lee Zheng YiiUniversity, hospital or other
- Collaborators
- Fresenius Kabi
- Study start
- 7 Jul 2026 (actual)
- Primary completion
- 7 Jul 2028 (estimated)
- Study completion
- 7 Jul 2029 (estimated)
- First posted
- 20 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High-dose fish oil | Experimental | Drug: Omegaven (10% fish-oil emulsion; Fresenius-Kabi)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 |
| Low-dose fish oil | Experimental | 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 |
| Usual Care | No intervention | –Usual care without additional intravenous fish oil. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omegaven (10% fish-oil emulsion; Fresenius-Kabi)Also: Fish oil triglycerides; intravenous fish-oil lipid emulsionOmegaven 10% intravenous fish-oil lipid emulsion | Drug | High-dose fish oil, Low-dose fish oil |
Primary outcome
Change in blood interleukin-6 (IL-6) concentration from Day 1 to Day 4
Time frame: Day 1 (before intervention) and Day 4 after randomization
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.
19 secondary outcomes
Area under the blood IL-6 concentration-time curve from Day 1 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
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
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
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
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
Time frame: Day 1 (before intervention), Day 4, and Day 7 after randomization
Blood concentrations of 58 lipid mediators
Time frame: Day 1 (before intervention), Day 4, and Day 7 after randomization
Red blood cell eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) levels
Time frame: Day 1 (before intervention), Day 4, and Day 7 after randomization
Rectus femoris cross-sectional area measured by ultrasound
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
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
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
Time frame: From ICU admission until ICU discharge or death, up to Day 60 after randomization
Hospital length of stay
Time frame: From hospital admission until hospital discharge or death, up to Day 60 after randomization
Duration of Mechanical Ventilation
Time frame: From ICU admission until hospital discharge, death, or Day 60 after randomization, whichever occurs first
Day 28 persistent organ dysfunction or death
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
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
Time frame: At hospital discharge, or on Day 28 after randomization if the participant remains hospitalized
Medical Research Council sum score for muscle strength
Time frame: Before hospital discharge, up to Day 28 after randomization
Short Physical Performance Battery (SPPB) total score
Time frame: Before hospital discharge, up to Day 28 after randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zheng Yii Lee, PhD principal investigator
University of Malaya
Shahnaz Hasan principal investigator
University of Malaya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Omegaven (10% fish-oil emulsion; Fresenius-Kabi) in people with Critical Illness, run by Lee Zheng Yii at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zheng Yii Lee, PhD (+60169754153, zheng_yii@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in blood interleukin-6 (IL-6) concentration from Day 1 to Day 4 (time frame: Day 1 (before intervention) and Day 4 after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.