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

Inflammatory Response Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00600912
• Other study ID #: SMOF 5178
• Secondary ID: kli-Lu-spiper 12
• Status: Completed
• Phase: Phase 4
• First received: January 14, 2008
• Last updated: December 2, 2009
• Start date: December 2006
• Est. completion date: December 2007

Study information

• Verified date: December 2009
• Source: Klinikum Ludwigshafen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatic Function
• Inflammatory Response

Intervention

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.
• 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.

Locations

Country	Name	City	State
Germany	Klinikum der Stadt Ludwigshafen, Department of Anesthesiology and Intensive Care Medicine	Ludwigshafen

Sponsors (1)

Lead Sponsor	Collaborator
Klinikum Ludwigshafen

Country where clinical trial is conducted

Germany, 

References & Publications (3)

Adolph M. Lipid emulsions in parenteral nutrition. Ann Nutr Metab. 1999;43(1):1-13. Review. — View Citation

Antébi H, Mansoor O, Ferrier C, Tétégan 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. — View Citation

Grimm H, Mertes N, Goeters C, Schlotzer E, Mayer K, Grimminger F, Fürst P. Improved fatty acid and leukotriene pattern with a novel lipid emulsion in surgical patients. Eur J Nutr. 2006 Feb;45(1):55-60. Epub 2005 Jul 22. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary objective is to monitor the leucotriene (LT) LTB5 in patients requiring parenteral nutrition		5 days	Yes
Secondary	Hepatic function assessed by measuring alpha-glutathione S-transferase (a-GST), alanin-aminotransferase (ALT),and aspartate-aminotransferase (AST)		5 days	Yes