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Lipid Emulsions and Liver Function - Results After 5 Years. | Clinical Trials | Clareo Health

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Lipid Emulsions and Liver Function - Results After 5 Years.

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

NCT04347902•Stanley Dudrick's Memorial Hospital

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - 80 years

Sex

ALL

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.

Locations (1)

Stanley Dudrick's Memorial Hospital

Skawina, Poland

Key Dates

Start Date

January 1, 2016

Primary Completion Date

March 1, 2020

Completion Date

April 1, 2020

Last Updated

April 17, 2020

Enrollment

ACTUAL participants

Conditions

Liver FailureParenteral Nutrition-Related Hepatitis

Interventions

Intravenous Lipid Emulsion

DRUG

ALSS - DPMAS and Therapeutic Plasma Exchange (TPE), Its Effect on Primary Coagulation, Inflammation and the Function of Vital Organs in ALF or ACLF

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Acute Liver Failure

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RECRUITINGNA

Standard Volume vs. High Volume Plasma Exchange in Pediatric Acute Liver Failure

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Acute Liver Failure

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RECRUITING

Analysis of Methylomic Features and Prognostic Risk Prediction in Patients With Hepatitis B-related Acute-on-chronic Liver Failure

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 17, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Lipid Emulsions and Liver Function - Results After 5 Years.

Inclusion Criteria

Exclusion Criteria

ALSS - DPMAS and Therapeutic Plasma Exchange (TPE), Its Effect on Primary Coagulation, Inflammation and the Function of Vital Organs in ALF or ACLF

Standard Volume vs. High Volume Plasma Exchange in Pediatric Acute Liver Failure

Analysis of Methylomic Features and Prognostic Risk Prediction in Patients With Hepatitis B-related Acute-on-chronic Liver Failure

Single Cell Landscape of HBV-related Acute-on-chronic Liver Failure Patients

The Safety ,Tolerability and Efficacy Study of HepaCure in Chinese Subjects with Acute-On-Chronic Liver Failure

Study About Hepatic Toxins Kinetic and Evaluation of Organ Damage in Acute on Chronic Liver Failure (ACLF) Patients