NCT00600912

Influence of of a Lipid Emulsion on Inflammatory Response and Hepatic Function

Inflammatory Response and Hepatic Function in Patients Requiring Parenteral Nutrition: Comparison of a Lipid Emulsion Based ob Soybean Oil, Medium-Chain Triglycerides, Olive Oil and Fish Oil Versus a Lipid Emulsion Based on Olive and Soybean Oil

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Klinikum Ludwigshafen · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Lipid emulsions are an essential part of parenteral nutrition, both as a part of energy supply, and as a source of essential fatty acids. It has been shown that the fatty acid composition of cell membranes is influenced by the fatty acid profile of dietary lipids, and may therefore be responsible for modulation of immune response. The aim of this study was to assess the effects of a new lipid emulsion based ob soybean oil, medium-chain triglycerides, olive oil and fish oil compared with a lipid emulsion based on olive and soybean oil on the inflammatory response and hepatic function in postoperative intensive care unit (ICU) patients.

Detailed description

Fatty emulsions are an indispensable part of parenteral nutrition, because they deliver energy and essential fatty acids. Furthermore, lipids are involved in the structure and function of cell membranes and receptors, modifying gene expression, and modulating the inflammatory and immune response. In addition, fatty acids are precursors of prostaglandins and other eicosanoids and have therefore important metabolic functions.A promising substrate in the development of lipid emulsions can be seen in fish oils containing solutions. With regard to the current literature, fish oil have a potential benefical influence on the pathophysiological response to endotoxins and exert important modulations on eicosanoid and cytokine biology. However, there are no studies avaibale comparing fish oil containing fatty emulsions to a lipid emulsion based on olive and soybean oil with regard to inflammatory response and hepatic function. Therefore, the aim of this study was to evaluate the effects of a new lipid emulsion based ob soybean oil, medium-chain triglycerides, olive oil and fish oil compared to a lipid emulsion based on olive and soybean oil on the inflammatory response and hepatic function in postoperative intensive care unit (ICU) patients.

Conditions

• Inflammatory Response
• Hepatic Function

Interventions

Type	Name	Description
DRUG	SMOFlipid®	continuously, for 5 days postoperatively, corresponding to the observation time. Nonprotein calories: to 60% as glucose and to 40% as lipid emulsion. The total energy intake per day was adjusted to 25 kcal kg-1 body weight.
DRUG	2-ClinOleic 20%®	continuously, for 5 days postoperatively, corresponding to the observation time. Nonprotein calories: to 60% as glucose and to 40% as lipid emulsion. The total energy intake per day was adjusted to 25 kcal kg-1 body weight.

Timeline

• Start date: 2006-12-01
• Primary completion: 2007-12-01
• Completion: 2007-12-01
• First posted: 2008-01-25
• Last updated: 2009-12-03

Locations

1 site across 1 country: Germany