Liver Failure Clinical Trial
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)
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.
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