Back to resultsLipid Emulsions and Liver Function - Results After 5 Years. (5ylipids)
Primary Purpose
Liver Failure, Parenteral Nutrition-Related Hepatitis
Status
Completed
Phase
Phase 4
Locations
Poland
Study Type
Interventional
Intervention
Intravenous Lipid Emulsion
Sponsored by
About this trial
This is an interventional prevention trial for Liver Failure
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.
Sites / Locations
- Stanley Dudrick's Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
PN with SMOFLipid
PN with Olive oil
PN with MCT/LCT
Arm Description
Parenteral nutrition with MCT/LCT/olive oil/fish oil (SMOFLipid, Fresenius Kabi, Germany, SMOF group)
Parenteral nutrition with Olive oil/LCT 80:20 (ClinOleic, Baxter Healthcare, USA, OO group)
Parenteral nutrition with - Medium/long-chain triglycerides 50:50 (Lipofundin, B Braun Germany, MCT/LCT group)
Outcomes
Primary Outcome Measures
Liver disfunction
Liver tests results during parenteral nutrition
Secondary Outcome Measures
Full Information
NCT ID
NCT04347902
First Posted
April 13, 2020
Last Updated
April 15, 2020
Sponsor
Stanley Dudrick's Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04347902
Brief Title
Lipid Emulsions and Liver Function - Results After 5 Years.
Acronym
5ylipids
Official Title
Intravenous Lipid Emulsions and Liver Function in Adult Chronic Intestinal Failure Patients: New Results After 5 Years.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
January 2016 (Actual)
Primary Completion Date
March 2020 (Actual)
Study Completion Date
April 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanley Dudrick's Memorial Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Failure, Parenteral Nutrition-Related Hepatitis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Randomized, controlled, clinical trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PN with SMOFLipid
Arm Type
Experimental
Arm Description
Parenteral nutrition with MCT/LCT/olive oil/fish oil (SMOFLipid, Fresenius Kabi, Germany, SMOF group)
Arm Title
PN with Olive oil
Arm Type
Active Comparator
Arm Description
Parenteral nutrition with Olive oil/LCT 80:20 (ClinOleic, Baxter Healthcare, USA, OO group)
Arm Title
PN with MCT/LCT
Arm Type
Active Comparator
Arm Description
Parenteral nutrition with - Medium/long-chain triglycerides 50:50 (Lipofundin, B Braun Germany, MCT/LCT group)
Intervention Type
Drug
Intervention Name(s)
Intravenous Lipid Emulsion
Intervention Description
Various types of intravenous lipids
Primary Outcome Measure Information:
Title
Liver disfunction
Description
Liver tests results during parenteral nutrition
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stanislaw Klek, PhD
Organizational Affiliation
Stanley Dudrick's Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanley Dudrick's Memorial Hospital
City
Skawina
ZIP/Postal Code
32-050
Country
Poland
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29960156
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.
Results Reference
result
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Lipid Emulsions and Liver Function - Results After 5 Years.
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