Lipid Emulsions and Liver Function - Results After 5 Years.

Study Overview
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Brief Summary
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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
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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.

Official Title
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Intravenous Lipid Emulsions and Liver Function in Adult Chronic Intestinal Failure Patients: New Results After 5 Years.

Conditions
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Liver Failure, Parenteral Nutrition-Related Hepatitis

Intervention / Treatment
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* Drug: Intravenous Lipid Emulsion


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, controlled, clinical trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PN with SMOFLipid<br>Parenteral nutrition with MCT/LCT/olive oil/fish oil (SMOFLipid, Fresenius Kabi, Germany, SMOF group) | Drug: Intravenous Lipid Emulsion<br>* Various types of intravenous lipids<br>|
| Active Comparator: PN with Olive oil<br>Parenteral nutrition with Olive oil/LCT 80:20 (ClinOleic, Baxter Healthcare, USA, OO group) | Drug: Intravenous Lipid Emulsion<br>* Various types of intravenous lipids<br>|
| Active Comparator: PN with MCT/LCT<br>Parenteral nutrition with - Medium/long-chain triglycerides 50:50 (Lipofundin, B Braun Germany, MCT/LCT group) | Drug: Intravenous Lipid Emulsion<br>* Various types of intravenous lipids<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Liver disfunction | Liver tests results during parenteral nutrition | 5 years |