Pilot, randomized, double-blind clinical trial to determine the phytosterolaemia in hospitalized patients treated with total parenteral nutrition and gamma-glutamyltransferase alteration - Phystosterolemia and liver function in hospitalized adults treated with parenteral nutrition

Josep Llop Talaveron0 个研究点开始时间: 2014年10月16日最近更新: 2014年11月24日

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•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

•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

发起方

Josep Llop Talaveron