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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Ludwigshafen, Germany, 67063
- Klinikum der Stadt Ludwigshafen, Department of Anesthesiology and Intensive Care Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: 1-SMOFlipid®
lipid emulsion based on soybean oil, medium-chain triglycerides, olive oil and fish oil SMOFlipid®-Group (n = 21)
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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.
Other Names:
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Active Comparator: 2-ClinOleic 20%®
olive and soybean oil-group (n=21)
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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The primary objective is to monitor the leucotriene (LT) LTB5 in patients requiring parenteral nutrition
Time Frame: 5 days
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5 days
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Hepatic function assessed by measuring alpha-glutathione S-transferase (α-GST), alanin-aminotransferase (ALT),and aspartate-aminotransferase (AST)
Time Frame: 5 days
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5 days
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Swen N. Piper, Dr. med., Klinikum Ludwigshafen, Department of Anaesthesiology, Ludwigshafen, Germany
Publications and helpful links
General Publications
- Grimm H, Mertes N, Goeters C, Schlotzer E, Mayer K, Grimminger F, Furst P. Improved fatty acid and leukotriene pattern with a novel lipid emulsion in surgical patients. Eur J Nutr. 2006 Feb;45(1):55-60. doi: 10.1007/s00394-005-0573-8. Epub 2005 Jul 22.
- Antebi H, Mansoor O, Ferrier C, Tetegan M, Morvan C, Rangaraj J, Alcindor LG. Liver function and plasma antioxidant status in intensive care unit patients requiring total parenteral nutrition: comparison of 2 fat emulsions. JPEN J Parenter Enteral Nutr. 2004 May-Jun;28(3):142-8. doi: 10.1177/0148607104028003142.
- Adolph M. Lipid emulsions in parenteral nutrition. Ann Nutr Metab. 1999;43(1):1-13. doi: 10.1159/000012761.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SMOF 5178
- kli-Lu-spiper 12-2007
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