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

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04711564
• Other study ID #: 23618724
• Status: Completed
• Start date: March 29, 2018
• Est. completion date: April 15, 2020

Study information

• Verified date: January 2021
• Source: Karadeniz Technical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 15, 2020
• Est. primary completion date: March 25, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Sepsis
• Toxemia

Intervention

Other:
• Olive oil-based intravenous fat emulsions
Parenteral nutrition planned according to the requirements of the patients is given for ten days.
• Soybean-based intravenous fat emulsions
Parenteral nutrition planned according to the requirements of the patients is given for ten days.

Locations

Country	Name	City	State
Turkey	Karadeniz Technical University Medical Faculty Department of Anesthesiology and Reanimation	Trabzon

Sponsors (2)

Lead Sponsor	Collaborator
Karadeniz Technical University	Turkish Society of Clinical Enteral & Parenteral Nutrition

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	28-day mortality	Mortality rate	28 day