K70.3 K74.6 E44.0 E46
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - Diagnosis of malnutrition according to ESPEN / GLIM criteria - Liver cirrhosis (Child-Pugh stadium A-C) based on clinical characteristics, histological findings and / or imaging criteria (sonography, CT or MRI)
Exclusion criteria
Exclusion criteria: - parenteral nutrition in the previous 6 months - ongoing nutritional Intervention (over more than the past 7 days, e.g. intake of oral nutritional supplements) - pregnancy or breastfeeding - pacemaker or implanted defibrillator - tumor diseases in the past 3 years - known hepatocellular carcinoma - state after liver transplantation - TIPS - coexistant chronic pancreatitis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is feasibility (in the overall collective): - Dropout rate after the end of nutritional supplementation, after 3 and 6 months after discharge from the clinic - Compliance of oral nutritional supplements drinking: ingested versus recommended drinking quantity - Compliance in the nutritional counsellig: number of performed, postponed and canceled vis-à-vis therapy sessions and phone calls The primary aims of the study are: 1. Testing the feasibility and tolerance (therapy adherence) of a cross-sector, nutritional care (standard of care) in malnourished patients with liver cirrhosis, which is regarded as particularly challenging by the outpatient follow-up care over a period of 6 months. 2. The collection of biochemical parameters, which are analyzed together with data from the EnErGie cross-sectional study (DRKS00021124) in a complex mechanistic model on the genesis and course of malnutrition and sarcopenia. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary goals are the reduction of malnutrition and of sarcopenia, the improvement of anthropometric measurements, body composition (increase of the skeletal muscle mass), nutritional quality, systemic inflammation and other clinical-chemical blood parameters ??as well as muscle strength and function. | — |
Countries
Germany
Contacts
Klinik für Innere Medizin, Abteilung für Gastroenterologie und Endokrinologie