Lipid Emulsions and Liver Function - Results After 5 Years. (5ylipids)

Stanley Dudrick's Memorial Hospital

Status and phase: Completed; Phase 4

Conditions: Parenteral Nutrition-Related Hepatitis; Liver Failure

Treatments: Drug: Intravenous Lipid Emulsion

Study type: Interventional

Funder types: Other

Identifiers

NCT04347902

Lipids-5 year

Details and patient eligibility

About

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.

Full 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.

Enrollment: 65 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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65 participants in 3 patient groups

PN with SMOFLipid

Experimental group

Description:

Parenteral nutrition with MCT/LCT/olive oil/fish oil (SMOFLipid, Fresenius Kabi, Germany, SMOF group)

Treatment:

Drug: Intravenous Lipid Emulsion

PN with Olive oil

Active Comparator group

Description:

Parenteral nutrition with Olive oil/LCT 80:20 (ClinOleic, Baxter Healthcare, USA, OO group)

Treatment:

Drug: Intravenous Lipid Emulsion

PN with MCT/LCT

Active Comparator group

Description:

Parenteral nutrition with - Medium/long-chain triglycerides 50:50 (Lipofundin, B Braun Germany, MCT/LCT group)

Treatment:

Drug: Intravenous Lipid Emulsion