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

This study has been completed.
Sponsor:
Information provided by:
Klinikum Ludwigshafen
ClinicalTrials.gov Identifier:
NCT00600912
First received: January 14, 2008
Last updated: December 2, 2009
Last verified: December 2009
History of Changes
  Purpose

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 Intervention Phase
Inflammatory Response
Hepatic Function
 Drug: SMOFlipid®
Drug: 2-ClinOleic 20%®
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Klinikum Ludwigshafen:

Primary Outcome Measures:
  • The primary objective is to monitor the leucotriene (LT) LTB5 in patients requiring parenteral nutrition [ Time Frame: 5 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Hepatic function assessed by measuring alpha-glutathione S-transferase (α-GST), alanin-aminotransferase (ALT),and aspartate-aminotransferase (AST) [ Time Frame: 5 days ] [ Designated as safety issue: Yes ]

Enrollment: 42
Study Start Date: December 2006
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00600912

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

Publications:

Responsible Party: Klinikum Ludwigshafen, Dep. of Anesthesiology, Dr. S. N. Piper
ClinicalTrials.gov Identifier: NCT00600912     History of Changes
Other Study ID Numbers: SMOF 5178, kli-Lu-spiper 12-2007
Study First Received: January 14, 2008
Last Updated: December 2, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Klinikum Ludwigshafen:
lipid emulsion
fish oil
parenteral nutrition
leucotriene LTB5
hepatic function

ClinicalTrials.gov processed this record on June 17, 2013