Clinical trial NCT04347902: Lipid Emulsions and Liver Function - Results After 5 Years.
Official title: Intravenous Lipid Emulsions and Liver Function in Adult Chronic Intestinal Failure Patients: New Results After 5 Years.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Liver Failure
Parenteral Nutrition-Related Hepatitis
Lead sponsor: Stanley Dudrick's Memorial Hospital
Sponsor class: OTHER
First posted: 2020-04-15
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, controlled, clinical trial
Primary purpose: PREVENTION

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.

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 criteria: 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.

Primary outcomes:
measure: Liver disfunction
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Skawina
country: Poland
facility: Stanley Dudrick's Memorial Hospital
Study officials:
affiliation: Stanley Dudrick's Memorial Hospital
name: Stanislaw Klek, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.