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Completed

NCT Number: NCT00600912

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

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.

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Key information

Conditions

Inflammatory Response Hepatic Function Hyperphagia Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

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

Ludwigshafen, 67063, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SMOFlipid®

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.

Other names: SMOFlipid 20%® (Fresenius Kabi Deutschland GmbH,Bad Homburg, Germany)

2-ClinOleic 20%®

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.

Other names: ClinOleic 20%® (Baxter Deutschland GmbH,Unterschleissheim, Germany)

Primary outcomes

  1. The primary objective is to monitor the leucotriene (LT) LTB5 in patients requiring parenteral nutrition

    Time frame: 5 days

Secondary outcomes

  1. Hepatic function assessed by measuring alpha-glutathione S-transferase (α-GST), alanin-aminotransferase (ALT),and aspartate-aminotransferase (AST)

    Time frame: 5 days

Sponsors and collaborators

Lead sponsor

Klinikum Ludwigshafen

Other

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Jan 25, 2008
Registry last updated
Dec 3, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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