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

Completed

• Conditions: Sepsis
• Interventions: Other: Soybean-based intravenous fat emulsions; Other: Olive oil-based intravenous fat emulsions

• Registration Number: NCT04711564
• Lead Sponsor: Karadeniz Technical University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-29
• Primary Completion: 2020-03-25
• Study Completion: 2020-04-15
• Status Verified: 2021-01
• Study First Submitted: 2021-01-13
• Study First Submitted QC: 2021-01-13
• Last Update Submitted: 2021-01-13
• Study First Posted: 2021-01-15
• Last Update Posted: 2021-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Provision of soybean emulsions in PN	Soybean-based intravenous fat emulsions	Soybean-based (Kabiven: 100% LCT provided in a complete all-in-one PN bag)
Provision of olive oil emulsions in PN	Olive oil-based intravenous fat emulsions	Olive oil-based (Oliclinomel: 80% OO, 20% LCT provided in a complete all-in-one PN bag by Baxter) parenteral nutrition

Primary Outcome Measures

Name	Time	Method
Change of the adipokine in the first ten days in onset sepsis	Baseline and 10 days	Adipokines levels are assayed using a enzyme-linked immunosorbent assay

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Karadeniz Technical University Medical Faculty Department of Anesthesiology and Reanimation; 🇹🇷 Trabzon, Turkey