High Dose Intravenous Fish Oil Reduces Inflammation and Improves Liver Function
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 51
- Locations
- 1
- Primary Endpoint
- Change in Il-6 concentration
Study Overview
Brief Summary
Retrospective analysis of 51 patients (27 female, 24 male, mean age 51.5±12.6 years) who received all-in-one PN including amino acids, glucose and lipids supplemented with pure fish oil LE was performed.
Detailed Description
All patients depended on parenteral nutrition (PN) are prone to inflammation. This condition may aggravate already existing proinflammatory status and can become a critical factor for developing liver dysfunction (LD). Intravenous fish oil may attenuate the inflammatory status, , however, data on its use in adults is scarce. The aim of the study was to investigate the impact of the addition of pure fish oil intravenous lipid emulsion (ILE) as part of short- and long term PN in patients either at risk or with already existing inflammation.
Retrospective analysis of 51 patients (27 female, 24 male, mean age 51.5±12.6 years) who received all-in-one PN including amino acids, glucose and lipids supplemented with pure fish oil LE was performed. Pure fish oil emulsion (Omegaven®, Fresenius Kabi) was used as the additional product along with the standard lipid emulsion to reach a fish oil dose of approx. 0.5 g fish oil/kg/d. Diagnoses were chronic intestinal failure (CIF, n=20), Crohn's disease (CD, n=22), and Ulcerative colitis (UC, n=19). The observation period was 12 months for CIF and 21days for UC and CD.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •≥ 18 years of age,
- •metabolic stability (the absence of pathological laboratory resulting in the change of PN regime for at least one month)
- •ability to tolerate up to 1.0 g lipids/kg body weight per day as a part of PN.
Exclusion Criteria
- •patients with a history of cancer and anti-cancer treatment within the last 5 years, severe hyperlipidemia, severe coagulopathy, severe renal insufficiency, acute thromboembolic events, positive test for HIV, Hepatitis B or C (from medical history), known or suspected drug or alcohol abuse, participation in another interventional clinical trial in parallel or within three months prior to the start of this clinical trial, for women with childbearing potential (i.e. females who are not chemically or surgically sterile or females who are not postmenopausal) or women of childbearing potential tested positive on standard pregnancy test (urine dipstick) or/and lactation.
Arms & Interventions
Inflammatory bowel disease
Patients with either Crohn's disease (CD, n=22), and Ulcerative colitis (UC, n=19).
Intervention: Omegaven (Drug)
Chronic intestinal failure
Patients with intestinal failure (CIF, n=20)
Intervention: Omegaven (Drug)
Outcomes
Primary Outcomes
Change in Il-6 concentration
Time Frame: 4 weeks
Serum concentration of Il-6 (pg/mL)
Change in bilirubin concentration
Time Frame: 4 weeks
Serum concentration of bilirubin (umol/L)
Change in SGPT concentration
Time Frame: 4 weeks
Serum concentration of SGPT(U/l)
Change in procalcytonin concentration
Time Frame: 4 weeks
Serum concentration of procalcytonin (ng/mL)
Change in C-reactive protein concentration
Time Frame: 4 weeks
Serum concentration of CRP (mg/l)
Change in hsCRP concentration
Time Frame: 4 weeks
Serum concentration of hsCRP (pg/mL)
Change in interleukin-10 concentration
Time Frame: 4 weeks
Serum concentration of IL-10 (pg/mL)
Change in SGOT concentration
Time Frame: 4 weeks
Serum concentration of SGOT (U/l)
Change in alkaline phosphatase concentration
Time Frame: 4 weeks
Serum concentration of alkaline phosphatase (U/l)
Secondary Outcomes
No secondary outcomes reported
Investigators
Stanislaw Klek
Head of the Unit
Stanley Dudrick's Memorial Hospital