Pilot, randomized, double-blind clinical trial to determine the phytosterols in blood in hospitalized patients treated with total parenteral nutrition and gamma-glutamyltransferase alteratio

Conditions: Adult hospitalized patients with parenteral nutrition and liver disfunction
MedDRA version: 17.0Level: LLTClassification code 10008641Term: Cholestatic liver diseaseSystem Organ Class: 100000004871
MedDRA version: 17.0Level: PTClassification code 10074151Term: Parenteral nutrition associated liver diseaseSystem Organ Class: 10022117 - Injury, poisoning and procedural complications
Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

Registration Number: EUCTR2014-003597-17-ES

Lead Sponsor: Josep Llop Talaveron

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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

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