K91.2
Conditions
Interventions
Group 1: Cross-section (parenteral nutrition = 6 months): All participants underwent one cross-sectional study visit including liver function assessment (LiMAx, ICG, FibroScan), nutritional status ass
Sponsors
Charité - Universitätsmedizin Berlin Chirurgische Klinik Campus Charité Mitte l Campus Virchow-Klinikum
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Patients with intestinal failure receiving total parenteral nutrition 2. patients' age between 18 and 100 years 3. written informed consent
Exclusion criteria
Exclusion criteria: 1. Patients with previous liver surgery (excluding cholecystectomy) 2. Patients with active cancer 3. Patients with underlying liver disease or systemic disease not related to PN with significant impact on liver function 4. Patients receiving medical treatment with significant impact on liver function (e.g. chemotherapy)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint is to identify protective and adverse predictors of liver function by liver function assessment (LiMAx, ICG, FibroScan), nutritional status assessment (indirect calorimeter, BIA) and quality of life assessment (SF-36, SBS-QoL) based on one study visit in the cross-section and four study visits (inclusion, 6 months, 12 months, 24 months) in the longitudinal section. | — |
Secondary
| Measure | Time frame |
|---|---|
| Establishment and validation of noninvasive liver function tests (LiMAx, ICG, FibroScan). | — |
Countries
Germany
Contacts
Public ContactMartin Stockmann
Charité - Universitätsmedizin Berlin Chirurgische Klinik Campus Charité Mitte l Campus Virchow-Klinikum
Outcome results
None listed