Liver FailurePhase 45ylipidsNCT04347902
Lipid Emulsions and Liver Function - Results After 5 Years.
A Phase 4 study testing Intravenous Lipid Emulsion in people with Liver Failure and Parenteral Nutrition-Related Hepatitis, run by Stanley Dudrick's Memorial Hospital at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Liver Failure, Parenteral Nutrition-Related Hepatitis
- What is being tested?
- Intravenous Lipid Emulsion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 sitePoland
- Study dates
- Jan 2016to Apr 2020
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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
Who cannot join
- 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,
Show all 10Show fewer
- 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.
About this study
Official title: 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.
Read the 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.
- Being tested
- Intravenous Lipid Emulsion
- Medical subject headings
- Liver Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous Lipid EmulsionDrug
Various types of intravenous lipids
| Study group | Role | What they receive |
|---|---|---|
| PN with SMOFLipid | Experimental | Parenteral nutrition with MCT/LCT/olive oil/fish oil (SMOFLipid, Fresenius Kabi, Germany, SMOF group) Receives: Drug: Intravenous Lipid Emulsion |
| PN with Olive oil | Active comparator | Parenteral nutrition with Olive oil/LCT 80:20 (ClinOleic, Baxter Healthcare, USA, OO group) Receives: 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) Receives: Drug: Intravenous Lipid Emulsion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver disfunction
Liver tests results during parenteral nutrition
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2020
- Study startJan 2016
- Primary completionMar 2020
- Study completionApr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Liver FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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, controlled, clinical trial
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanley Dudrick's Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stanislaw Klek, Stanley Dudrick's Memorial Hospital
- Investigators
- Stanislaw Klek, PhD, Principal investigator, Stanley Dudrick's Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04347902
- Sponsor's protocol ID
- Lipids-5 year
- Acronym
- 5ylipids
- Status last verified
- Apr 2020
- First submitted
- 13 Apr 2020
- Last updated
- 17 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 29960156
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Lipid Emulsions and Liver Function in Adult Chronic Intestinal Failure Patients: New Results After 5 Years.
- ClinicalTrials.gov ID
- NCT04347902
- Acronym / sponsor ID
- 5ylipids / Lipids-5 year
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Stanley Dudrick's Memorial HospitalUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Mar 2020 (actual)
- Study completion
- Apr 2020 (actual)
- First posted
- 15 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Randomized, controlled, clinical trial
| Arm | Type | Receives |
|---|---|---|
| PN with SMOFLipid | Experimental | Drug: Intravenous Lipid EmulsionParenteral nutrition with MCT/LCT/olive oil/fish oil (SMOFLipid, Fresenius Kabi, Germany, SMOF group) |
| PN with Olive oil | Active comparator | Drug: Intravenous Lipid EmulsionParenteral nutrition with Olive oil/LCT 80:20 (ClinOleic, Baxter Healthcare, USA, OO group) |
| PN with MCT/LCT | Active comparator | Drug: Intravenous Lipid EmulsionParenteral nutrition with - Medium/long-chain triglycerides 50:50 (Lipofundin, B Braun Germany, MCT/LCT group) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥ 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
Key exclusion criteria (10 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravenous Lipid EmulsionVarious types of intravenous lipids | Drug | PN with MCT/LCT, PN with Olive oil, PN with SMOFLipid |
Primary outcome
Liver disfunction
Time frame: 5 years
Liver tests results during parenteral nutrition
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2020.
- Results publication: PubMed 29960156Klek 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.
- Individual participant dataSharing planned: No
Related trials for Liver Failure
Active, not recruiting
Leveraging Technology to Improve Medication Adherence in Youth With Kidney or Liver Transplant
Transplant;Failure,Kidney, Transplant; Failure, Liver
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Not yet recruiting
Effect of Mini-Program Monitoring on Hepatic Encephalopathy in Post-TIPS Patients
Hepatic Encephalopathy, Liver Cirrhosis
Recruiting
Evaluation of Fibroscan® Performance in Diagnosing Acute Heart Failure in Patients Presenting to the Emergency Department
Acute Heart Failure (AHF)
RecruitingObservational study
Establishing a Reference Framework for Outcomes After Machine-Preserved Liver Transplantation in Europe
End-stage Liver Disease (ESLD), Acute Liver Failure
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stanislaw Klek, PhD principal investigator
Stanley Dudrick's Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intravenous Lipid Emulsion in people with Liver Failure and Parenteral Nutrition-Related Hepatitis, 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 4 inclusion and 10 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 17 Apr 2020. 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 disfunction (time frame: 5 years). 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 NCT04347902, which also lists 1 linked publication.
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 17 Apr 2020.