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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Inflammatory Response, Hepatic Function

Intervention / Treatment
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* Drug: SMOFlipid®
* Drug: 2-ClinOleic 20%®


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-80 years Elective operative procedure, and indication for parenteral nutrition over 5 postoperative days ASA I-III Haemoglobin > 10 g/dl Ability and acceptance to agree to the study participation Written informed consent Exclusion Criteria: Liver insufficiency (ASAT, ALAT > 40 U/l) Renal insufficiency (creatinine > 1.4 mg/dl) Pancreas insufficiency Emergencies Women in child bearing age and missing negative pregnancy test, pregnancy or lactation Diseases from the central nervous system (such as M. Parkinson and multiple sclerosis) Alcohol and drug abuse (including opioid abuse) Acute pulmonary oedema Decompensated cardiac insufficiency Insulin-dependent diabetes mellitus Overweight (body mass index > 30 kg/m2 Cachexia (body mass index < 18 kg/m2) Psychiatric disorders Hypersensitivity to egg, coconut or soy proteins Patients taking chronic corticoids Allergy to any of the study agents Refusal from the patient to participate in the study Participation in another study project

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1-SMOFlipid®<br>lipid emulsion based on soybean oil, medium-chain triglycerides, olive oil and fish oil SMOFlipid®-Group (n = 21) | Drug: SMOFlipid®<br>* 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.<br>* Other names: SMOFlipid 20%® (Fresenius Kabi Deutschland GmbH,Bad Homburg, Germany);|
| Active Comparator: 2-ClinOleic 20%®<br>olive and soybean oil-group (n=21) | Drug: 2-ClinOleic 20%®<br>* 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.<br>* Other names: ClinOleic 20%® (Baxter Deutschland GmbH,Unterschleissheim, Germany);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary objective is to monitor the leucotriene (LT) LTB5 in patients requiring parenteral nutrition |  | 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hepatic function assessed by measuring alpha-glutathione S-transferase (α-GST), alanin-aminotransferase (ALT),and aspartate-aminotransferase (AST) |  | 5 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lipid emulsion, fish oil, parenteral nutrition, leucotriene LTB5, hepatic function