Liver Failure, Parenteral Nutrition-Related Hepatitis
Conditions
Brief summary
Intravenous lipid emulsion (ILE) is an essential component of parenteral nutrition (PN), but also one of the key risk factors for development of intestinal failure associated liver disease (IFALD). The aim of the study was to analyse the influence of ILEs on liver function during long term PN.
Detailed description
Intravenous lipid emulsion (ILE) is an essential component of parenteral nutrition (PN), but also one of the key risk factors for development of intestinal failure associated liver disease (IFALD). Despite of many commercially available ILEs with hypothetically different impact on liver, a direct comparison of them has never been performed. Therefore the aim of the study was to analyse the influence of ILEs on liver function during long term PN. Ths study is a continuation of the previous trial, NCT03044639.
Interventions
Various types of intravenous lipids
Sponsors
Stanley Dudrick's Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Randomized, controlled, clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* ≥ 18 years of age, * chronic intestinal failure on PN including lipids, * metabolic stability (the absence of pathological laboratory resulting in the change of PN regime for at least one month) * ability to tolerate up to 1.0 g lipids/kg body weight per day as a part of PN
Exclusion criteria
* preexisting liver dysfunction (an elevation of SGOT, SGTP, total bilirubin, GGTP, alkaline phosphatase of more than 3 times x normal value), * patients with a history of cancer and anti-cancer treatment within the last 5 years, * severe hyperlipidemia, * severe coagulopathy, * severe renal insufficiency, * acute thromboembolic events, * positive test for HIV, Hepatitis B or C (from medical history), * known or suspected drug or alcohol abuse, * participation in another interventional clinical trial in parallel or within three months prior to the start of this clinical trial, * for women with childbearing potential (i.e. females who are not chemically or surgically sterile or females who are not postmenopausal) or women of childbearing potential tested positive on standard pregnancy test (urine dipstick) or/and lactation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Liver disfunction | 5 years | Liver tests results during parenteral nutrition |
Countries
Poland
Outcome results
None listed