Clinical trial NCT04711564: The Effects of Different Lipid Emulsions on the Adipokines in Critically Ill Patients With Sepsis
Official title: The Effects of Different Lipid Emulsions on the Adipokines, Inflammatory Markers and Mortality in Critically Ill Patients With Sepsis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sepsis
Keywords: Parenteral Nutrition
Sepsis
Adipokines
Inflammation
Intensive Care
Lead sponsor: Karadeniz Technical University
Sponsor class: OTHER
Collaborators: name: Turkish Society of Clinical Enteral & Parenteral Nutrition
First posted: 2021-01-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Critically ill patients with sepsis aged 18-85 years given parenteral nutrition therapy

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change of the adipokine in the first ten days in onset sepsis
timeFrame: Baseline and 10 days
Secondary outcomes:
measure: Intensive care unit length of stay
timeFrame: Time of admission to the ICU until the time of discharge from the intensive care unit, up to 1 year
measure: 28-day mortality
timeFrame: 28 day
Other outcomes:
Locations:
city: Trabzon
country: Turkey
facility: Karadeniz Technical University Medical Faculty Department of Anesthesiology and Reanimation
Study officials:
affiliation: Karadeniz Technical University
name: Melda Kangalgil, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Karadeniz Technical University
name: Ahmet Oguzhan Kucuk, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Karadeniz Technical University
name: Asiye Ozdemir, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Karadeniz Technical University
name: Süleyman Caner Karahan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Karadeniz Technical University
name: Umitcan Ok, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Karadeniz Technical University
name: Hatice Bozkurt Yavuz, MD
role: PRINCIPAL_INVESTIGATOR
References: