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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

January 14, 2008
January 25, 2008
December 3, 2009
December 2006
December 2007   (Final data collection date for primary outcome measure)
The primary objective is to monitor the leucotriene (LT) LTB5 in patients requiring parenteral nutrition [ Time Frame: 5 days ]
The primary objective is to monitor the leucotriene (LT) LTB5 in patients requiring parenetarl nutrition [ Time Frame: 5 days ]
Complete list of historical versions of study NCT00600912 on ClinicalTrials.gov Archive Site
Hepatic function assessed by measuring alpha-glutathione S-transferase (α-GST), alanin-aminotransferase (ALT),and aspartate-aminotransferase (AST) [ Time Frame: 5 days ]
Same as current
Not Provided
Not Provided
 
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
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.

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.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
  • Inflammatory Response
  • Hepatic Function
  • 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)
  • 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)
  • Experimental: 1-SMOFlipid®
    lipid emulsion based on soybean oil, medium-chain triglycerides, olive oil and fish oil SMOFlipid®-Group (n = 21)
    Intervention: Drug: SMOFlipid®
  • Active Comparator: 2-ClinOleic 20%®
    olive and soybean oil-group (n=21)
    Intervention: Drug: 2-ClinOleic 20%®

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
Same as current
December 2007
December 2007   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT00600912
SMOF 5178
kli-Lu-spiper 12-2007
No
Not Provided
Not Provided
Klinikum Ludwigshafen, Dep. of Anesthesiology, Dr. S. N. Piper
Klinikum Ludwigshafen
Not Provided
Principal Investigator: Swen N. Piper, Dr. med. Klinikum Ludwigshafen, Department of Anaesthesiology, Ludwigshafen, Germany
Klinikum Ludwigshafen
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP