Parenteral Lipid Emulsions and the Liver Function

Study Overview
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Brief Summary
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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
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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.

Official Title
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Four Parenteral Lipid Emulsions and the Liver Function

Conditions
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Liver Failure

Intervention / Treatment
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* Drug: Lipid Emulsions, Intravenous


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized, double-blind, multi-centric study performed in four parallel groups
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Provision of LCT emulsions in PN<br>Intervention: 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. | Drug: Lipid Emulsions, Intravenous<br>* 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.<br>* Other names: parenteral lipid provision;|
| Experimental: Provision of MCT/LCT emulsions in PN<br>Intervention: 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. | Drug: Lipid Emulsions, Intravenous<br>* 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.<br>* Other names: parenteral lipid provision;|
| Experimental: Provision of Olive oil emulsions in PN<br>Intervention: 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. | Drug: Lipid Emulsions, Intravenous<br>* 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.<br>* Other names: parenteral lipid provision;|
| Experimental: Provision of SMOF lipid emulsions in PN<br>Intervention: 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. | Drug: Lipid Emulsions, Intravenous<br>* 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.<br>* Other names: parenteral lipid provision;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Liver function | Measurement of bilirubin - at the beginning and every three months up to 12 months | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Liver function 2 | Measurement of SGTP - at the beginning and every three months up to 12 months | 12 months | 
| Liver function 3 | Measurement of SGOT - at the beginning and every three months up to 12 months | 12 months | 
| Liver function 4 | Measurement of GGTP - at the beginning and every three months up to 12 months | 12 months | 
| Liver function 5 | Measurement of alkaline phosphatase - at the beginning and every three months up to 12 months | 12 months |