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

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

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.

Study Overview

• Status: Completed
• Conditions: Liver Failure; Parenteral Nutrition-Related Hepatitis
• Intervention / Treatment: Drug: Intravenous Lipid Emulsion

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 Type: Interventional
• Enrollment (Actual): 65
• Phase: Phase 4

Contacts and Locations

Study Locations

• Poland
  • Skawina, Poland, 32-050
    • Stanley Dudrick's Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PN with SMOFLipid; Parenteral nutrition with MCT/LCT/olive oil/fish oil (SMOFLipid, Fresenius Kabi, Germany, SMOF group)	Drug: Intravenous Lipid Emulsion; Various types of intravenous lipids
Active Comparator: PN with Olive oil; Parenteral nutrition with Olive oil/LCT 80:20 (ClinOleic, Baxter Healthcare, USA, OO group)	Drug: Intravenous Lipid Emulsion; Various types of intravenous lipids
Active Comparator: PN with MCT/LCT; Parenteral nutrition with - Medium/long-chain triglycerides 50:50 (Lipofundin, B Braun Germany, MCT/LCT group)	Drug: Intravenous Lipid Emulsion; Various types of intravenous lipids

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Liver disfunction	Liver tests results during parenteral nutrition	5 years

Collaborators and Investigators

• Sponsor: Stanley Dudrick's Memorial Hospital

Publications and helpful links

General Publications

• 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: 10.1016/j.nut.2018.03.008. Epub 2018 Mar 22.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): March 1, 2020
• Study Completion (Actual): April 1, 2020

Study Registration Dates

• First Submitted: April 13, 2020
• First Submitted That Met QC Criteria: April 13, 2020
• First Posted (Actual): April 15, 2020

Study Record Updates

• Last Update Posted (Actual): April 17, 2020
• Last Update Submitted That Met QC Criteria: April 15, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Hepatic Insufficiency; Liver Diseases; Liver Failure; Pharmaceutical Solutions; Parenteral Nutrition Solutions; Fat Emulsions, Intravenous
• Other Study ID Numbers: Lipids-5 year

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No