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Sponsored by: |
Klinikum Ludwigshafen |
Information provided by: | Klinikum Ludwigshafen |
ClinicalTrials.gov Identifier: | NCT00600912 |
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.
Condition | Intervention |
Inflammatory Response Hepatic Function |
Drug: SMOFlipid® Drug: 2-ClinOleic 20%® |
Drug Information available for: | Dextrose Fish oil Soybean oil Lipids |
Study Type: | Observational |
Study Design: | Case Control, Prospective |
Official Title: | 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 |
Enrollment: | 42 |
Study Start Date: | December 2006 |
Study Completion Date: | December 2007 |
Primary Completion Date: | December 2007 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
1-SMOFlipid®
lipid emulsion based on soybean oil, medium-chain triglycerides, olive oil and fish oil SMOFlipid®-Group (n = 21)
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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.
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2-ClinOleic 20%®
olive and soybean oil-group (n=21)
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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.
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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.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
42 patients, scheduled for elective major surgery, postoperative admission to the ICU and who were expected to need parenteral nutrition over 5 postoperative days are screened before surgery for potential in- and exclusion criteria
Inclusion Criteria:
Exclusion Criteria:
Germany | |||||
Klinikum der Stadt Ludwigshafen, Department of Anesthesiology and Intensive Care Medicine | |||||
Ludwigshafen, Germany, 67063 |
Klinikum Ludwigshafen |
Principal Investigator: | Swen N. Piper, Dr. med. | Klinikum Ludwigshafen, Department of Anaesthesiology, Ludwigshafen, Germany |
Responsible Party: | Dr. S. N. Piper ( Klinikum Ludwigshafen, Dep. of Anesthesiology ) |
Study ID Numbers: | SMOF 5178, kli-Lu-spiper 12-2007 |
First Received: | January 14, 2008 |
Last Updated: | January 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00600912 |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
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