Hypertriglyceridemia is a frequent metabolic complication associated with the administration of lipidic emulsion in total parenteral nutrition.
Conditions
Interventions
Trade Name: Omegaven
Product Name: Omegaven
Pharmaceutical Form: Emulsion for injection
INN or Proposed INN: EICOSAPENTANOIC ACID/DOCOSAHEXAENOIC ACID
Sponsors
Elisabet Leiva Badosa. Phamacy Department. Hospital Universitari de Bellvitge
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects must be 18 years of age or older and may be of both genders and of any race / ethnicity. 2. Subjects must be willing to give written informed consent for the trial and be able to do. Otherwise, it can be done by the legal representative. 3. Subjects should have triglyceride levels between 3 and 4.5 mmol / L and have been treated for at least 1 day with NP. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
Exclusion criteria: 1. Subjects may not have a history of type I hypersensitivity or idiosyncratic reactions to any component of lipid emulsions. 2. Women who are pregnant or breast-feeding. 3. Subjects treated with propofol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: In hospitalized adult patients treated with parenteral nutrition who have hypertriglyceridemia (> 3 mmol / L) after the administration of a lipid emulsion with olive oil/soybean standard at 0.8 g/kg/day, the main objective is to determine whether the change to lipidic emulsion of fish oil (100% ?-3 fatty acids) maintaining the same dose is equally effective in reducing triglycerides at 3, 7 and 14 days of treatment, and 3 days after starting the oral intake, than the reduction of the contribution to 0.5 g / kg / day in the emulsion of olive oil/soy or fish oil lipid emulsion 50:50 olive oil keeping the same dose.; Secondary Objective: - Determine if the change to 0.8 g / kg / day of fish oil lipid emulsion (100% ?-3 fatty acids) or intravenous lipid emulsion of fish oil: 50:50 olive oil maintaining the same dose, at 3, 7 and 14 days of treatment and 3 days after starting the oral intake, with respect to the reduction of the contribution to 0.5g / kg / day in the emulsion of olive oil: soy improves the nutritional parameters (albumin, prealbumin and lymphocytes), improves the inflammatory parameters (PCR, Il-6, Il-9, Il-10 and TNF-alpha), reduces the levels of plasma phytosterols and improves the lipid profile of patients (cholesterol, VLDL, HDL, HDL, APO-B); - To determine the association between a reduction of plasmatic phytosterols with the polymorphisms rs11887534, rs4245791, rs41360247, rs4148217, and rs657152. ;Primary end point(s): Temporal variation of plasma triglycerides and will be collected on day 0 (day of randomization) and on days 3, 7 and 14 post-randomization and 3 days after starting the oral intake; Timepoint(s) of evaluation of this end point: Planned start date: 09/24/2018 Expected completion date: 09/30/2021 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Nutritional parameters: Albumin, prealbumin, lymphocytes and glucose - Inflammatory parameters: C-reactive protein (CRP), Il-6, Il-10 and TNF-alpha - Plasma phytosterols - Polymorphisms: rs11887534, rs41360247, rs4245791i rs657152 - Lipid profile: total cholesterol, VLDL, HDL, LDL, APO-B - Safety parameters: platelet count and prothrombin time - Liver parameters: gamma-glutamyl transferase, alkaline phosphatase, alanine amino transferase and total bilirubin - Parameters of renal function: Creatinine, Urea ; Timepoint(s) of evaluation of this end point: Planned start date: 09/24/2018 Expected completion date: 09/30/2021 | — |
Countries
Spain
Contacts
Public ContactElisabet Leiva Badosa
Hospital Universitari de Bellvitge
Outcome results
None listed