Adult hospitalized patients with parenteral nutrition and liver disfunction MedDRA version: 17.0 Level: LLT Classification code 10008641 Term: Cholestatic liver disease System Organ Class: 100000004871 MedDRA version: 17.0 Level: PT Classification code 10074151 Term: Parenteral nutrition associated liver disease System Organ Class: 10022117 - Injury, poisoning and procedural complications
Conditions
Interventions
Trade Name: Omegaven
Pharmaceutical Form: Emulsion for infusion
INN or Proposed INN: EICOSAPENTANOIC ACID/DOCOSAHEXAENOIC ACID
Other descriptive name: Fish oil
Concentration unit: % (W/V) percent weig
Sponsors
Josep Llop Talaveron
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients admitted to the Department of General and Digestive Surgery who meet ALL the criteria: 1. Adult hospitalized patients with parenteral nutrition and normal initial values ??of the liver function parameters (GGT, ALT, AST, ALP and total bilirubin), who after at least 7 days of treatment with NP present GGT values ??greater than or equal to twice the normal value (2 x the upper limit of normal). 2. Must be 18 years or more and may be of either sex and of any race / ethnicity. 3 shall be ready to give their written informed consent to the test and be able to do consent. If a subject can not give written informed consent independently, you can do your legal representative in place.3. Subjects must be willing to give their written informed consent for the test and be able to do. If a subject can not grant your informe consent written independently, you can do your legal representative in place in those cases included in the RD223/2004. 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 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: 1. Background of type I hypersensitivity or idiosyncratic reaction to any component of the intravenous lipid emulsions. 2. Pregnant or lactating 3. Plasma triglycerides> 3 mmol/L 4. Treatment with corticosteroids or immunosuppressive chronically in the previous month. 5. AIDS patients 6. Transplanted 7 Contraindications according to the data sheet of the lipid emulsions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: In hospitalized adult patients with alteration of the liver function parameters after seven days of administration of the parenteral nutrition, lipid supply will be reduced by 50%. After this reduction, the main objectives are: - To determine whether to switch to lipid emulsions of fish oil are more effective in reducing plasma levels of phytosterols than to maintain an emulsion of vegetable origin. - To determine the correlation between phytosterolaemia in both groups with the changing values ??of gamma glutamyl transferase.;Secondary Objective: Secondary objectives are: - To determine the correlation between plasma levels of phytosterols and the evolution of the values ??of GGT. - To determine the correlation between plasma levels of phytosterols in both groups with alkaline phosphatase, alanine aminotransferase and total bilirubin values. - To determine the correlation between plasma levels of phytosterols in both groups with inflammatory response, expressed as C-reactive protein, interleukin 6, tumor necrosis factor and interleukin-10 - To evaluate the safety of switching to emulsions with omega 3 fatty acids by monitoring plasma determinations: triglycerides, platelet count and prothrombin time. - To determine the correlation between plasma levels of phytosterols in patients and the amount of phytosterols administered.;Primary end point(s): The main endpoints are: a. Total plasma phytosterols and the following fractions: brassicasterol, beta-sitostanol, beta-sitosterol, campesterol, cholesterol, desmosterol, ergosterol, lanosterol, lathosterol and stigmasterol b. GGT;Timepoint(s) of evaluation of this end point: The main endpoints will be collected on days 0 (day of randomization) and on days 7, 14 and 21 after randomization | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints collected are: a. Liver parameters: alkaline phosphatase, ALT and total bilirubin b. Safety parameters: triglycerides, platelet count and prothrombin time c. Total amount of phytosterols administered in grams/Kg d. Parameters of renal function: Creatinine e. Inflammatory response parameters: C-reactive protein, interleukin-6, tumor necrosis factor and interleukin-10 f. Nutritional parameters: Albumin, Prealbumin and Lymphocytes;Timepoint(s) of evaluation of this end point: The secondary endpoints will be collected on days 0 (day of randomization) and on days 7, 14 and 21 after randomization | — |
Countries
Spain
Contacts
Public ContactJosep M Llop Talaveron
Hospital Universitari de Bellvitge
Outcome results
None listed