Lipid Emulsions and Liver Function - Results After 5 Years.

NCT04347902 | Completed Phase 4

• 1 other identifier: Lipids-5 year
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Liver Failure; Parenteral Nutrition-Related Hepatitis

Outcome Measures

Primary Outcomes (1)

• Liver disfunction

  Liver tests results during parenteral nutrition

  5 years

Study Arms (3)

PN with SMOFLipid

EXPERIMENTAL

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

Drug: Intravenous Lipid Emulsion

PN with Olive oil

ACTIVE COMPARATOR

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

Drug: Intravenous Lipid Emulsion

PN with MCT/LCT

ACTIVE COMPARATOR

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

Drug: Intravenous Lipid Emulsion

Interventions

Intravenous Lipid Emulsion DRUG

Various types of intravenous lipids

PN with MCT/LCT; PN with Olive oil; PN with SMOFLipid

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanley Dudrick's Memorial Hospital: lead

Study Sites (1)

Stanley Dudrick's Memorial Hospital

Skawina, 32-050, Poland

Location

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

  PMID: 29960156 RESULT

MeSH Terms

Conditions

Liver Failure

Interventions

Fat Emulsions, Intravenous

Condition Hierarchy (Ancestors)

Hepatic Insufficiency; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Emulsions; Colloids; Dosage Forms; Pharmaceutical Preparations; Parenteral Nutrition Solutions; Pharmaceutical Solutions; Solutions; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Study Officials

• Stanislaw Klek, PhD

  Stanley Dudrick's Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of the General Surgery Unit

Model Details: Randomized, controlled, clinical trial

Study Record Dates

• First Submitted: April 13, 2020
• First Posted: April 15, 2020
• Study Start: January 1, 2016
• Primary Completion: March 1, 2020
• Study Completion: April 1, 2020
• Last Updated: April 17, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)