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

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

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.

Study Overview

• Status: Completed
• Conditions: Sepsis
• Intervention / Treatment: Other: Olive oil-based intravenous fat emulsions; Other: Soybean-based intravenous fat emulsions

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• Turkey
  • Trabzon, Turkey
    • Karadeniz Technical University Medical Faculty Department of Anesthesiology and Reanimation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Critically ill patients with sepsis aged 18-85 years given parenteral nutrition therapy

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Provision of olive oil emulsions in PN; 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; Parenteral nutrition planned according to the requirements of the patients is given for ten days.
Provision of soybean emulsions in PN; Soybean-based (Kabiven: 100% LCT provided in a complete all-in-one PN bag)	Other: Soybean-based intravenous fat emulsions; Parenteral nutrition planned according to the requirements of the patients is given for ten days.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Karadeniz Technical University
• Collaborators: Turkish Society of Clinical Enteral & Parenteral Nutrition
• Investigators: Principal Investigator: Asiye Ozdemir, MD, Karadeniz Technical University; Principal Investigator: Umitcan Ok, MD, Karadeniz Technical University; Principal Investigator: Hatice Bozkurt Yavuz, MD, Karadeniz Technical University

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2018
• Primary Completion (Actual): March 25, 2020
• Study Completion (Actual): April 15, 2020

Study Registration Dates

• First Submitted: January 13, 2021
• First Submitted That Met QC Criteria: January 13, 2021
• First Posted (Actual): January 15, 2021

Study Record Updates

• Last Update Posted (Actual): January 15, 2021
• Last Update Submitted That Met QC Criteria: January 13, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Inflammation; Adipokines; Sepsis; Intensive Care; Parenteral Nutrition
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Toxemia; Pharmaceutical Solutions; Parenteral Nutrition Solutions; Soybean oil, phospholipid emulsion; Fat Emulsions, Intravenous
• Other Study ID Numbers: 23618724

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No