Surgery
Conditions
Keywords
Parenteral nutrition, Interleukin-1b, Interleukin-8, Lipid emulsion
Brief 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. 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.
Interventions
OTHERSMOFlipid 20%
Fish oil-enriched intravenous lipid emulsion
OTHERLipofundin 20%
MCT/LCT standard intravenous lipid emulsion
Sponsors
Dr. Soetomo General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Hours to 2 Months
Healthy volunteers
No
Inclusion criteria
* willing to participate in this study (through informed consent) * undergo gastrointestinal surgery * get parenteral nutrition for at least 3 days
Exclusion criteria
* chronic diseases * allergic to fish, egg, soy and/or nut proteins
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fatty Acids Composition | 3 days (before surgery and after surgery) | The percentage of fatty acid consentration from total fatty acids |
| Inflammatory response | 3 days (before surgery and after surgery) | Interleukin 1b and Interleukin 8 levels |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin | 3 days (before surgery and after surgery) | Hemoglobin value in all subjects |
| Leukocyte | 3 days (before surgery and after surgery) | Leukocyte value in all subjects |
| C reactive Protein | 3 days (before surgery and after surgery) | C Reactive Protein valuel in all subjects |
| Albumin | 3 days (before surgery and after surgery) | Albumin value in all subjects |
Countries
Indonesia
Outcome results
None listed