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

Phase 4

Completed

• Conditions: Inflammatory Response; Hepatic Function
• Interventions: Drug: SMOFlipid®; Drug: 2-ClinOleic 20%®

• Registration Number: NCT00600912
• Lead Sponsor: Klinikum Ludwigshafen

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.

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 Timeline

• Study Start: 2006-12
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Study First Submitted: 2008-01-14
• Study First Submitted QC: 2008-01-14
• Study First Posted: 2008-01-25
• Status Verified: 2009-12
• Last Update Submitted: 2009-12-02
• Last Update Posted: 2009-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1-SMOFlipid®	SMOFlipid®	lipid emulsion based on soybean oil, medium-chain triglycerides, olive oil and fish oil SMOFlipid®-Group (n = 21)
2-ClinOleic 20%®	2-ClinOleic 20%®	olive and soybean oil-group (n=21)

Primary Outcome Measures

Name	Time	Method
The primary objective is to monitor the leucotriene (LT) LTB5 in patients requiring parenteral nutrition	5 days

Secondary Outcome Measures

Name	Time	Method
Hepatic function assessed by measuring alpha-glutathione S-transferase (α-GST), alanin-aminotransferase (ALT),and aspartate-aminotransferase (AST)	5 days

Trial Locations

Locations (1)

Klinikum der Stadt Ludwigshafen, Department of Anesthesiology and Intensive Care Medicine; 🇩🇪 Ludwigshafen, Germany