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

Klinikum Ludwigshafen

Status and phase

Completed

Phase 4

Conditions

Inflammatory Response

Hepatic Function

Treatments

Drug: 2-ClinOleic 20%®

Drug: SMOFlipid®

Study type

Interventional

Funder types

Other

Identifiers

NCT00600912

kli-Lu-spiper 12-2007

SMOF 5178

Details and patient eligibility

About

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.

Full 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.

Enrollment

42 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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