Influence of of a Lipid Emulsion on Inflammatory Response and Hepatic Function
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ClinicalTrials.gov Identifier: NCT00600912 |
Recruitment Status :
Completed
First Posted : January 25, 2008
Last Update Posted : December 3, 2009
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Inflammatory Response Hepatic Function | Drug: SMOFlipid® Drug: 2-ClinOleic 20%® | Phase 4 |
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 : | Interventional (Clinical Trial) |
Actual Enrollment : | 42 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double |
Primary Purpose: | Treatment |
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 |
Study Start Date : | December 2006 |
Actual Primary Completion Date : | December 2007 |
Actual Study Completion Date : | December 2007 |

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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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.
Other Name: SMOFlipid 20%® (Fresenius Kabi Deutschland GmbH,Bad Homburg, Germany) |
Active Comparator: 2-ClinOleic 20%®
olive and soybean oil-group (n=21)
|
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.
Other Name: ClinOleic 20%® (Baxter Deutschland GmbH,Unterschleissheim, Germany) |
- The primary objective is to monitor the leucotriene (LT) LTB5 in patients requiring parenteral nutrition [ Time Frame: 5 days ]
- 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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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00600912
Germany | |
Klinikum der Stadt Ludwigshafen, Department of Anesthesiology and Intensive Care Medicine | |
Ludwigshafen, Germany, 67063 |
Principal Investigator: | Swen N. Piper, Dr. med. | Klinikum Ludwigshafen, Department of Anaesthesiology, Ludwigshafen, Germany |
Responsible Party: | Klinikum Ludwigshafen, Dep. of Anesthesiology, Dr. S. N. Piper |
ClinicalTrials.gov Identifier: | NCT00600912 |
Other Study ID Numbers: |
SMOF 5178 kli-Lu-spiper 12-2007 |
First Posted: | January 25, 2008 Key Record Dates |
Last Update Posted: | December 3, 2009 |
Last Verified: | December 2009 |
lipid emulsion fish oil parenteral nutrition leucotriene LTB5 hepatic function |
SMOFlipid Fat Emulsions, Intravenous Parenteral Nutrition Solutions Pharmaceutical Solutions |