Lipid Emulsions and Liver Function - Results After 5 Years.

Liver Failure Clinical Trial

— 5ylipids  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04347902
• Other study ID #: Lipids-5 year
• Status: Completed
• Phase: Phase 4
• Start date: January 2016
• Est. completion date: April 2020

Study information

• Verified date: April 2020
• Source: Stanley Dudrick's Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: April 2020
• Est. primary completion date: March 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Liver Failure
• Parenteral Nutrition-Related Hepatitis

Intervention

Drug:
• Intravenous Lipid Emulsion
Various types of intravenous lipids

Locations

Country	Name	City	State
Poland	Stanley Dudrick's Memorial Hospital	Skawina

Sponsors (1)

Lead Sponsor	Collaborator
Stanley Dudrick's Memorial Hospital

Country where clinical trial is conducted

Poland, 

References & Publications (1)

Klek S, Szczepanek K, Scislo L, Walewska E, Pietka M, Pisarska M, Pedziwiatr M. Intravenous lipid emulsions and liver function in adult chronic intestinal failure patients: results from a randomized clinical trial. Nutrition. 2018 Nov;55-56:45-50. doi: 10 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Liver disfunction	Liver tests results during parenteral nutrition	5 years