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Liver FailurePhase 4NCT03044639

Parenteral Lipid Emulsions and the Liver Function

A Phase 4 study testing Lipid Emulsions, Intravenous in people with Liver Failure, run by Stanley Dudrick's Memorial Hospital at 1 site in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Liver Failure
What is being tested?
Lipid Emulsions, Intravenous
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
64 participants
Where
1 sitePoland
Study dates
1 Apr 2010to 31 Dec 2016
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • chronic intestinal failure (CIF) receiving HPN including lipids
  • 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)
  • 1.0 g lipids/kg body weight per day as a part of PN

Who cannot join

  • Existing liver failure: an elevation of SGOT, SGTP, total bilirubin, GGTP, alkaline phosphatase of more than 1.5 times x normal value
  • Patients in whom PN was interrupted for longer than 4 continuous weeks in the preceding 6 months
  • Patients with history of cancer and anti-cancer treatment within the last 5 years
  • Severe hyperlipidemia
  • Severe coagulopathy
  • Severe renal insufficiency
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Poland1 site

  • Stanley Dudrick's Memorial Hospital

    Skawina, 32-050

Other trials in Poland

About this study

Official title: Four Parenteral Lipid Emulsions and the Liver Function

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)
Read the 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.

Conditions
Liver Failure
Being tested
Lipid Emulsions, Intravenous
Medical subject headings
Liver Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lipid Emulsions, IntravenousDrug

    Also called parenteral lipid provision

    The every day provision of lipid emulsion as a part of parenteral nutrition along with dextrose, amino acids, electrolytes, trace elements, vitamins and water in the dose of 0.8-1.0 g/kg/day.

Study groups in NCT03044639
Study groupRoleWhat they receive
Provision of LCT emulsions in PNExperimentalIntervention: Lipid Emulsions, Intravenous. Daily provision of LCT-based lipid emulsion as a part of parenteral nutrition along with dextrose, amino acids, electrolytes, trace elements, vitamins and water in the dose of 0.8-1.0 g/kg/day.
Receives: Drug: Lipid Emulsions, Intravenous
Provision of MCT/LCT emulsions in PNExperimentalIntervention: Lipid Emulsions, Intravenous. Daily provision of MCT/LCT lipid emulsion as a part of parenteral nutrition along with dextrose, amino acids, electrolytes, trace elements, vitamins and water in the dose of 0.8-1.0 g/kg/day.
Receives: Drug: Lipid Emulsions, Intravenous
Provision of Olive oil emulsions in PNExperimentalIntervention: Lipid Emulsions, Intravenous. Daily provision of Olive-oil/ LCT lipid emulsion as a part of parenteral nutrition along with dextrose, amino acids, electrolytes, trace elements, vitamins and water in the dose of 0.8-1.0 g/kg/day.
Receives: Drug: Lipid Emulsions, Intravenous
Provision of SMOF lipid emulsions in PNExperimentalIntervention: Lipid Emulsions, Intravenous. Daily provision of SMOF lipid emulsion as a part of parenteral nutrition along with dextrose, amino acids, electrolytes, trace elements, vitamins and water in the dose of 0.8-1.0 g/kg/day.
Receives: Drug: Lipid Emulsions, Intravenous

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Liver function

    Measurement of bilirubin - at the beginning and every three months up to 12 months

    Measured: 12 months

Secondary outcomes (4)

  1. Liver function 2

    Measurement of SGTP - at the beginning and every three months up to 12 months

    Measured: 12 months

  2. Liver function 3

    Measurement of SGOT - at the beginning and every three months up to 12 months

    Measured: 12 months

  3. Liver function 4

    Measurement of GGTP - at the beginning and every three months up to 12 months

    Measured: 12 months

  4. Liver function 5

    Measurement of alkaline phosphatase - at the beginning and every three months up to 12 months

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Feb 2017 (estimated)
  2. Study start1 Apr 2010
  3. Primary completion31 Oct 2016
  4. Study completion31 Dec 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized, double-blind, multi-centric study performed in four parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03044639
Sponsor's protocol ID
IVLE
Status last verified
Jan 2017
First submitted
22 Jan 2017
Last updated
7 Feb 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 19426581

  • 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.

    PubMed 20072779

  • 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.

    PubMed 29960156

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Lipid Emulsions, Intravenous in people with Liver Failure, run by Stanley Dudrick's Memorial Hospital at 1 site in Poland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Liver function (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03044639, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2017.

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