drugset / Trial / NCT03044639
Parenteral Lipid Emulsions and the Liver Function
RandomizedParallel-groupSingle-blindPrevention
Summary
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)
Timeline
- Start
- 2010-04-01
- Primary completion
- 2016-10-31
- Completion
- 2016-12-31
Publications
- Background Calder PC. Hot topics in parenteral nutrition. Rationale for using new lipid emulsions in parenteral nutrition and a review of the trials performed in adults. Proc Nutr Soc. 2009 Aug;68(3):252-60. doi: 10.1017/S0029665109001268. Epub 2009 May 11.
- Background Calder PC, Jensen GL, Koletzko BV, Singer P, Wanten GJ. Lipid emulsions in parenteral nutrition of intensive care patients: current thinking and future directions. Intensive Care Med. 2010 May;36(5):735-49. doi: 10.1007/s00134-009-1744-5. Epub 2010 Jan 14.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Long-chained triglycerides | Other / unclassified | 0.8 g/kg | Intravenous |
| Subject | Long-chained triglycerides | Other / unclassified | 1 g/kg | Intravenous |
| Subject | Medium/ long-chained triglycerides | Other / unclassified | 0.8 g/kg | Intravenous |
| Subject | Medium/ long-chained triglycerides | Other / unclassified | 1 g/kg | Intravenous |
| Subject | Olive oil | Other / unclassified | 0.8 g/kg | Intravenous |
| Subject | Olive oil | Other / unclassified | 1 g/kg | Intravenous |
| Subject | SMOFlipid | Other / unclassified | 0.8 g/kg | Intravenous |
| Subject | SMOFlipid | Other / unclassified | 1 g/kg | Intravenous |