SurgeryNCT04511299
Impact of Fish Oil-enriched Lipid Emulsion on Fatty Acid and Inflammatory Response in Infants After Surgery
A study testing SMOFlipid 20% and Lipofundin 20% in people with Surgery, run by Dr. Soetomo General Hospital at 1 site in Indonesia.
Trial summary
This study aim to compare the impact of fish oil-enriched intravenous lipid emulsion to standard Intravenous lipid emulsion on fatty acid composition and inflammatory response (IL-1β and IL-8 levels) in infants after gastrointestinal surgery. Read more about this study
- Who is it for?
- Ages 1 hour to 2 months
- Conditions the study is for
- Surgery
- What is being tested?
- SMOFlipid 20% and Lipofundin 20%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteIndonesia
- Study dates
- 7 Apr 2020to 13 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 1 hour to 2 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- willing to participate in this study (through informed consent)
- undergo gastrointestinal surgery
- get parenteral nutrition for at least 3 days
Who cannot join
- chronic diseases
- allergic to fish, egg, soy and/or nut proteins
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Fish Oil-enriched Intravenous Lipid Emulsion in Parenteral Nutrition of Phospholipid Fatty Acid Composition and Inflammatory Response in Infants After Gastrointestinal Surgery.
This study aim to compare the impact of fish oil-enriched intravenous lipid emulsion to standard Intravenous lipid emulsion on fatty acid composition and inflammatory response (IL-1β and IL-8 levels) in infants after gastrointestinal surgery. Our hypothesis is the fish oil-enriched intravenous lipid emulsion can improve the fatty acid composition and lower the inflammatory response.
Read the detailed description
This study is conducted in infants post gastrointestinal surgery that requires parenteral nutrition for at least 3 days. Subjects are classified into two groups. Group 1 received standard IVFE and group 2 received ω-3-enriched IVFE. The type of intravenous standard and omega-3-enriched fat emulsion used in this study are Lipofundin 20% and SMOFlipid 20%, respectively, both administered for three consecutive days after surgery (72 hours) in 1-4 gram/kilogram/day dosing. The inflammatory response (IL-1β and IL-8 levels) and fatty acid composition are checked from blood plasma. Blood examination is done before the surgery and 3 days after the surgery.
- Conditions
- Surgery
- Being tested
- SMOFlipid 20%, Lipofundin 20%
- Keywords
- Parenteral nutrition, Interleukin-1b, Interleukin-8, Lipid emulsion
- Medical subject headings
- Hyperphagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMOFlipid 20%Other
Fish oil-enriched intravenous lipid emulsion
Lipofundin 20%Other
MCT/LCT standard intravenous lipid emulsion
| Study group | Role | What they receive |
|---|---|---|
| Fish oil-enriched intravenous lipid emulsion | Experimental | SMOFlipid 20%, given for 3 consecutive days with 1-4 g/kg/day. Receives: Other: SMOFlipid 20% |
| Standard intavenous lipid emulsion | Active comparator | Lipofundin 20%, given for 3 consecutive days with 1-4 g/kg/day. Receives: Other: Lipofundin 20% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatty Acids Composition
The percentage of fatty acid consentration from total fatty acids
Measured: 3 days (before surgery and after surgery)
Inflammatory response
Interleukin 1b and Interleukin 8 levels
Measured: 3 days (before surgery and after surgery)
Secondary outcomes (4)
Hemoglobin
Hemoglobin value in all subjects
Measured: 3 days (before surgery and after surgery)
Leukocyte
Leukocyte value in all subjects
Measured: 3 days (before surgery and after surgery)
C reactive Protein
C Reactive Protein valuel in all subjects
Measured: 3 days (before surgery and after surgery)
Albumin
Albumin value in all subjects
Measured: 3 days (before surgery and after surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2020
- Study start7 Apr 2020
- Primary completion13 Jul 2020
- Study completion13 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SurgeryStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Soetomo General Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Meta Herdiana Hanindita, dr., Sp.A (K), Dr. Soetomo General Hospital
- Investigators
- Meta H Hanindita, Principal investigator, Dr. Soetomo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04511299
- Sponsor's protocol ID
- 1983/105/II/2020
- Status last verified
- Aug 2020
- First submitted
- 7 Aug 2020
- Last updated
- 13 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Fish Oil-enriched Intravenous Lipid Emulsion in Parenteral Nutrition of Phospholipid Fatty Acid Composition and Inflammatory Response in Infants After Gastrointestinal Surgery.
- ClinicalTrials.gov ID
- NCT04511299
- Acronym / sponsor ID
- 1983/105/II/2020
- Conditions
- Surgery
- Keywords
- Parenteral nutrition, Interleukin-1b, Interleukin-8, Lipid emulsion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Dr. Soetomo General HospitalOther government
- Study start
- 7 Apr 2020 (actual)
- Primary completion
- 13 Jul 2020 (actual)
- Study completion
- 13 Jul 2020 (actual)
- First posted
- 13 Aug 2020 (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.
This study aim to compare the impact of fish oil-enriched intravenous lipid emulsion to standard Intravenous lipid emulsion on fatty acid composition and inflammatory response (IL-1β and IL-8 levels) in infants after gastrointestinal surgery. Our hypothesis is the fish oil-enriched intravenous lipid emulsion can improve the fatty acid composition and lower the inflammatory response.
Detailed description
This study is conducted in infants post gastrointestinal surgery that requires parenteral nutrition for at least 3 days. Subjects are classified into two groups. Group 1 received standard IVFE and group 2 received ω-3-enriched IVFE. The type of intravenous standard and omega-3-enriched fat emulsion used in this study are Lipofundin 20% and SMOFlipid 20%, respectively, both administered for three consecutive days after surgery (72 hours) in 1-4 gram/kilogram/day dosing. The inflammatory response (IL-1β and IL-8 levels) and fatty acid composition are checked from blood plasma. Blood examination is done before the surgery and 3 days after the surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fish oil-enriched intravenous lipid emulsion | Experimental | Other: SMOFlipid 20%SMOFlipid 20%, given for 3 consecutive days with 1-4 g/kg/day. |
| Standard intavenous lipid emulsion | Active comparator | Other: Lipofundin 20%Lipofundin 20%, given for 3 consecutive days with 1-4 g/kg/day. |
Who may qualify
- Ages
- 1 hour to 2 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- willing to participate in this study (through informed consent)
- undergo gastrointestinal surgery
- get parenteral nutrition for at least 3 days
Key exclusion criteria (2 listed)
- chronic diseases
- allergic to fish, egg, soy and/or nut proteins
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 |
|---|---|---|
| SMOFlipid 20%Fish oil-enriched intravenous lipid emulsion | Other | Fish oil-enriched intravenous lipid emulsion |
| Lipofundin 20%MCT/LCT standard intravenous lipid emulsion | Other | Standard intavenous lipid emulsion |
Primary outcome
Fatty Acids Composition
Time frame: 3 days (before surgery and after surgery)
The percentage of fatty acid consentration from total fatty acids
Inflammatory response
Time frame: 3 days (before surgery and after surgery)
Interleukin 1b and Interleukin 8 levels
4 secondary outcomes
Hemoglobin
Time frame: 3 days (before surgery and after surgery)
Leukocyte
Time frame: 3 days (before surgery and after surgery)
C reactive Protein
Time frame: 3 days (before surgery and after surgery)
Albumin
Time frame: 3 days (before surgery and after surgery)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2020.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Meta H Hanindita principal investigator
Dr. Soetomo General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMOFlipid 20% and Lipofundin 20% in people with Surgery, run by Dr. Soetomo General Hospital at 1 site in Indonesia.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 13 Aug 2020. 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 Indonesia. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatty Acids Composition (time frame: 3 days (before surgery and after surgery)). The study lists 2 primary outcomes in all. 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 13 Aug 2020.