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

NCT ID: NCT00600912

Last Updated: 2009-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-12-31

Study Completion Date

2007-12-31

Brief Summary

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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

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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.

Conditions

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Inflammatory Response Hepatic Function

Keywords

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lipid emulsion fish oil parenteral nutrition leucotriene LTB5 hepatic function

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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1-SMOFlipid®

lipid emulsion based on soybean oil, medium-chain triglycerides, olive oil and fish oil SMOFlipid®-Group (n = 21)

Group Type EXPERIMENTAL

SMOFlipid®

Intervention Type DRUG

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%®

olive and soybean oil-group (n=21)

Group Type ACTIVE_COMPARATOR

2-ClinOleic 20%®

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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SMOFlipid 20%® (Fresenius Kabi Deutschland GmbH,Bad Homburg, Germany) ClinOleic 20%® (Baxter Deutschland GmbH,Unterschleissheim, Germany)

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Klinikum Ludwigshafen

OTHER

Sponsor Role lead

Responsible Party

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Dr. S. N. Piper

Principal Investigators

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Swen N. Piper, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Klinikum Ludwigshafen, Department of Anaesthesiology, Ludwigshafen, Germany

Locations

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Klinikum der Stadt Ludwigshafen, Department of Anesthesiology and Intensive Care Medicine

Ludwigshafen, , Germany

Site Status

Countries

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Germany

References

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Antebi H, Mansoor O, Ferrier C, Tetegan 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. doi: 10.1177/0148607104028003142.

Reference Type BACKGROUND
PMID: 15141405 (View on PubMed)

Grimm H, Mertes N, Goeters C, Schlotzer E, Mayer K, Grimminger F, Furst P. Improved fatty acid and leukotriene pattern with a novel lipid emulsion in surgical patients. Eur J Nutr. 2006 Feb;45(1):55-60. doi: 10.1007/s00394-005-0573-8. Epub 2005 Jul 22.

Reference Type BACKGROUND
PMID: 16041475 (View on PubMed)

Adolph M. Lipid emulsions in parenteral nutrition. Ann Nutr Metab. 1999;43(1):1-13. doi: 10.1159/000012761.

Reference Type BACKGROUND
PMID: 10364625 (View on PubMed)

Other Identifiers

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kli-Lu-spiper 12-2007

Identifier Type: -

Identifier Source: secondary_id

SMOF 5178

Identifier Type: -

Identifier Source: org_study_id