Lipid Emulsions and Liver Function - Results After 5 Years.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2020-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Parenteral Lipid Emulsions and the Liver Function

NCT03044639

Liver Failure

COMPLETED PHASE4

Standard Lipid Therapy vs IVFE Minimization for Prevention of PNALD

NCT02357576

Cholestasis

COMPLETED PHASE3

The Effect of Physical Properties of Lipid Emulsions on Gastrointestinal Function

NCT01253005

Healthy Controls

COMPLETED NA

Olive Oil and Soybean 1 Oil Based Intravenous Lipid Emulsions, Liver Chemistry and Clinical Outcomes

NCT03442361

Parenteral Nutrition Associated Liver Disease

COMPLETED

Reduction of Neonatal Parenteral Nutrition Associated Cholestasis Through Lipid Emulsions

NCT02633384

Intrahepatic, Cholestasis

TERMINATED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Liver Failure Parenteral Nutrition-Related Hepatitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized, controlled, clinical trial

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

PN with SMOFLipid

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

Group Type EXPERIMENTAL

Intravenous Lipid Emulsion

Intervention Type DRUG

Various types of intravenous lipids

PN with Olive oil

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

Group Type ACTIVE_COMPARATOR

Intravenous Lipid Emulsion

Intervention Type DRUG

Various types of intravenous lipids

PN with MCT/LCT

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

Group Type ACTIVE_COMPARATOR

Intravenous Lipid Emulsion

Intervention Type DRUG

Various types of intravenous lipids

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Intravenous Lipid Emulsion

Various types of intravenous lipids

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No