The Effects of Different Lipid Emulsions on the Adipokines in Critically Ill Patients With Sepsis

Study Overview
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Brief Summary
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Intravenous lipid emulsions contain a number of biologically active ingredients, but the most important are fatty acids. Different fatty acids can affect a number of different physiological processes in different ways in critically ill patients. Adipose tissue can play an important role in metabolic changes of critical illnesses and in adaptation to stress through structural as well as functional changes Although it is known that serum adipokine and cytokine response changes in critical sepsis patients, the factors affecting these changes and the metabolic consequences of these changes are not well defined. The aim of this study was to evaluate the effects of intravenous lipid emulsions on serum adipokine and cytokine levels in patients with sepsis. Secondly, this is to determine the adipokine and cytokine kinetics in the sepsis process and their relationship with mortality in patients with sepsis.

Official Title
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The Effects of Different Lipid Emulsions on the Adipokines, Inflammatory Markers and Mortality in Critically Ill Patients With Sepsis

Conditions
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Sepsis

Intervention / Treatment
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* Other: Olive oil-based intravenous fat emulsions
* Other: Soybean-based intravenous fat emulsions


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of sepsis within the last 24 h Age above 18 and below 85 years Indication of only parenteral nutrition therapy Exclusion Criteria: Planning any different medical nutrition therapy such as enteral nutrition, immunonutrition or oral nutrition Hypersensitivity (fish, egg or soy protein) Uncontrolled hemorrhage Uncontrolled hyperlipidemia Severe primary blood coagulation diseases Acute pancreatitis Acute thromboembolic diseases Severe liver failure RIFLE stage III and IV renal failure Pregnancy or lactation Expected stay in ICU not more than 10 days Expected survival not more than 10 days

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Provision of olive oil emulsions in PN<br>Olive oil-based (Oliclinomel: 80% OO, 20% LCT provided in a complete all-in-one PN bag by Baxter) parenteral nutrition | Other: Olive oil-based intravenous fat emulsions<br>* Parenteral nutrition planned according to the requirements of the patients is given for ten days.<br>|
| Provision of soybean emulsions in PN<br>Soybean-based (Kabiven: 100% LCT provided in a complete all-in-one PN bag) | Other: Soybean-based intravenous fat emulsions<br>* Parenteral nutrition planned according to the requirements of the patients is given for ten days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of the adipokine in the first ten days in onset sepsis | Adipokines levels are assayed using a enzyme-linked immunosorbent assay | Baseline and 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intensive care unit length of stay | Time from study inclusion to intensive care unit discharge. | Time of admission to the ICU until the time of discharge from the intensive care unit, up to 1 year | 
| 28-day mortality | Mortality rate | 28 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parenteral Nutrition, Sepsis, Adipokines, Inflammation, Intensive Care