Parenteral Lipid Emulsions and the Liver Function

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-01

Study Completion Date

2016-12-31

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)

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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.

Conditions

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Liver Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized, double-blind, multi-centric study performed in four parallel groups

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

No information on the lipid emulsion's type provided neither to the patient nor the leading physician

Study Groups

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Provision of LCT emulsions in PN

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.

Group Type EXPERIMENTAL