Liver Diseases, Alcoholic, Malnutrition
Conditions
Brief summary
The study is an unblinded randomized trial, designed to examine whether gastric- or jejunal feeding tubes are the most effect full to feed patients with alcoholic liver diseases and non-sufficient oral intake. The primary outcome will be differences in nutrition intake between the groups. Secondary outcomes will be: the amount of unplanned tube discontinuations; handgrip and patients' quality of life, nausea & vomiting. The study will include 40 patients at Aarhus University Hospital, Denmark.
Interventions
DEVICEGastric tube (Nutricia Flocare® Pur Tube Enlock)
Nutricia Flocare® Pur Tube Enlock, Ch. 12
DEVICEJejunal tube (Nutricia Flocare® Bengmark®)
Nutricia Flocare® Bengmark®, Ch. 10
Sponsors
University of Aarhus
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Alcoholic liver disease * nutrition intake less than 75% of needed intake * Signed informed consent form
Exclusion criteria
* Hepatic encephalopathy, grade 3 - 4 * Anatomic barriers to have a tube placed
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Differences in nutrition intake | Day 3 & 7 and every 7th. day until discharge from the hospital, up to 3 months | Nutrition intake, protein intake, oral intake versus tube intake |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Differences in patients reported outcomes | Day 3 & 7 and every 7th. day until discharge from the hospital, up to 3 months | Questionnaires |
Countries
Denmark
Outcome results
None listed