Clinical trial NCT03044639: Parenteral Lipid Emulsions and the Liver Function
Official title: Four Parenteral Lipid Emulsions and the Liver Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Liver Failure
Lead sponsor: Stanley Dudrick's Memorial Hospital
Sponsor class: OTHER
First posted: 2017-02-07
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, double-blind, multi-centric study performed in four parallel groups
Primary purpose: PREVENTION

Brief summary: The randomized, double-blind, multi-centric study performed in four parallel groups to compare all lipid emulsions, which can be used as a part of PN. Patients with home parenteral nutrition due to stable intestinal failure, were randomly assigned to receive parenteral nutrition with one the following lipid emulsions:

* Long-chained triglycerides (LCT group)
* Medium/ long-chained triglycerides MCT/LCT (50:50, MCT/LCT group))
* Olive oil/ LCT (80:20, OO group))
* SMOFlipid (Omega-3/ olive oil/ MCT/ LCT, SMOF group)

Detailed description: Intravenous lipid emulsion (IVLE) is the essential component of parenteral nutrition (PN), because it is a very efficient source of energy and essential fatty acids (FA).The prevalence of abnormal liver function tests during PN varies from 15 to 85%, according to most authors.\[19-21\] The severity of IFALD depends also on underlying disease, especially ongoing sepsis and pre-existing liver disease. A study comparing all lipid emulsions, which can be used as a part of PN, has never been done. The aim of the study was to compare the clinical value of the four most popular intravenous lipid emulsions in regards to the liver function in long term intestinal failure patients.Patients with home parenteral nutrition due to stable intestinal failure, were randomly assigned to receive parenteral nutrition with one the following lipid emulsions:

* Long-chained triglycerides (LCT group)
* Medium/ long-chained triglycerides MCT/LCT (50:50, MCT/LCT group))
* Olive oil/ LCT (80:20, OO group))
* SMOFlipid (Omega-3/ olive oil/ MCT/ LCT, SMOF group) Randomization was performed after assessment and check for in-/exclusion criteria if the patient has met all study eligibility requirements.

The test emulsion became a part of regular PN admixture, which was used to feed patient at home. The study was performed for 12 months.

Eligibility criteria: Inclusion Criteria:

1. chronic intestinal failure (CIF) receiving HPN including lipids
2. metabolic stability on HPN for more than three months (metabolic stability = the absence of pathological laboratory resulting in the change of PN regime for at least one month)
3. 1.0 g lipids/kg body weight per day as a part of PN

Exclusion Criteria:

1. Existing liver failure: an elevation of SGOT, SGTP, total bilirubin, GGTP, alkaline phosphatase of more than 1.5 times x normal value
2. Patients in whom PN was interrupted for longer than 4 continuous weeks in the preceding 6 months
3. Patients with history of cancer and anti-cancer treatment within the last 5 years
4. Severe hyperlipidemia
5. Severe coagulopathy
6. Severe renal insufficiency
7. Acute thromboembolic events
8. Positive test for HIV, Hepatitis B or C (from medical history)
9. Known or suspected drug or alcohol abuse
10. Participation in another interventional clinical trial in parallel or within three months prior to the start of this clinical trial
11. 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 function
timeFrame: 12 months
Secondary outcomes:
measure: Liver function 2
timeFrame: 12 months
measure: Liver function 3
timeFrame: 12 months
measure: Liver function 4
timeFrame: 12 months
measure: Liver function 5
timeFrame: 12 months
Other outcomes:
Locations:
city: Skawina
country: Poland
facility: Stanley Dudrick's Memorial Hospital
Study officials:
affiliation: Stanley Dudrick's Memorial Hospital
name: Stanislaw Klek, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Calder PC. Hot topics in parenteral nutrition. Rationale for using new lipid emulsions in parenteral nutrition and a review of the trials performed in adults. Proc Nutr Soc. 2009 Aug;68(3):252-60. doi: 10.1017/S0029665109001268. Epub 2009 May 11.
citation: Calder PC, Jensen GL, Koletzko BV, Singer P, Wanten GJ. Lipid emulsions in parenteral nutrition of intensive care patients: current thinking and future directions. Intensive Care Med. 2010 May;36(5):735-49. doi: 10.1007/s00134-009-1744-5. Epub 2010 Jan 14.
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.