Lipid Emulsions and Liver Function - Results After 5 Years.

Phase 4

Completed

• Conditions: Liver Failure; Parenteral Nutrition-Related Hepatitis
• Interventions: Drug: Intravenous Lipid Emulsion

• Registration Number: NCT04347902
• Lead Sponsor: Stanley Dudrick's Memorial Hospital

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.

Study Timeline

• Study Start: 2016-01
• Primary Completion: 2020-03
• Status Verified: 2020-04
• Study Completion: 2020-04
• Study First Submitted: 2020-04-13
• Study First Submitted QC: 2020-04-13
• Study First Posted: 2020-04-15
• Last Update Submitted: 2020-04-15
• Last Update Posted: 2020-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PN with SMOFLipid	Intravenous Lipid Emulsion	Parenteral nutrition with MCT/LCT/olive oil/fish oil (SMOFLipid, Fresenius Kabi, Germany, SMOF group)
PN with Olive oil	Intravenous Lipid Emulsion	Parenteral nutrition with Olive oil/LCT 80:20 (ClinOleic, Baxter Healthcare, USA, OO group)
PN with MCT/LCT	Intravenous Lipid Emulsion	Parenteral nutrition with - Medium/long-chain triglycerides 50:50 (Lipofundin, B Braun Germany, MCT/LCT group)

Primary Outcome Measures

Name	Time	Method
Liver disfunction	5 years	Liver tests results during parenteral nutrition

Trial Locations

Locations (1)

Stanley Dudrick's Memorial Hospital; 🇵🇱 Skawina, Poland