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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
Sponsor:
Information provided by:
Klinikum Ludwigshafen

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Inflammatory Response Hepatic Function Drug: SMOFlipid® Drug: 2-ClinOleic 20%® Phase 4

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 Design
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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

Resource links provided by the National Library of Medicine

Drug Information available for: SMOFlipid

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1-SMOFlipid®
lipid emulsion based on soybean oil, medium-chain triglycerides, olive oil and fish oil SMOFlipid®-Group (n = 21)
 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)


Outcome Measures
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Primary Outcome Measures :
  1. The primary objective is to monitor the leucotriene (LT) LTB5 in patients requiring parenteral nutrition [ Time Frame: 5 days ]

Secondary Outcome Measures :
  1. Hepatic function assessed by measuring alpha-glutathione S-transferase (α-GST), alanin-aminotransferase (ALT),and aspartate-aminotransferase (AST) [ Time Frame: 5 days ]

Eligibility Criteria
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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
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Germany
Klinikum der Stadt Ludwigshafen, Department of Anesthesiology and Intensive Care Medicine
Ludwigshafen, Germany, 67063
Sponsors and Collaborators
Klinikum Ludwigshafen
Investigators
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Principal Investigator: Swen N. Piper, Dr. med. Klinikum Ludwigshafen, Department of Anaesthesiology, Ludwigshafen, Germany
More Information
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Publications:

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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
Keywords provided by Klinikum Ludwigshafen:
lipid emulsion
fish oil
parenteral nutrition
leucotriene LTB5
hepatic function
Additional relevant MeSH terms:
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SMOFlipid
Fat Emulsions, Intravenous
Parenteral Nutrition Solutions
Pharmaceutical Solutions