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

NCT04711564 | Completed

• 1 other identifier: 23618724
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis

Keywords

Parenteral Nutrition; Sepsis; Adipokines; Inflammation; Intensive Care

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

• 28-day mortality

  28 day

Study Arms (2)

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

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

Interventions

Olive oil-based intravenous fat emulsions OTHER

Parenteral nutrition planned according to the requirements of the patients is given for ten days.

Provision of olive oil emulsions in PN

Soybean-based intravenous fat emulsions OTHER

Parenteral nutrition planned according to the requirements of the patients is given for ten days.

Provision of soybean emulsions in PN

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Diagnosis of sepsis within the last 24 h
• Age above 18 and below 85 years
• Indication of only parenteral nutrition therapy

You may not qualify if:

• 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

Sponsors & Collaborators

• Karadeniz Technical University: lead
• Turkish Society of Clinical Enteral and Parenteral Nutrition: collaborator

Study Sites (1)

Karadeniz Technical University Medical Faculty Department of Anesthesiology and Reanimation

Trabzon, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Adipokines (adiponectin, rezistin leptin and visfatin) and cytokines (IL-6, IL-10, IL-1β and TNF-α) in critically ill with sepsis

MeSH Terms

Conditions

Sepsis; Hyperphagia; Inflammation

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Signs and Symptoms

Study Officials

• Melda Kangalgil, MSc

  Karadeniz Technical University

  PRINCIPAL INVESTIGATOR

• Ahmet Oguzhan Kucuk, MD

  Karadeniz Technical University

  PRINCIPAL INVESTIGATOR

• Asiye Ozdemir, MD

  Karadeniz Technical University

  PRINCIPAL INVESTIGATOR

• Süleyman Caner Karahan, MD

  Karadeniz Technical University

  PRINCIPAL INVESTIGATOR

• Umitcan Ok, MD

  Karadeniz Technical University

  PRINCIPAL INVESTIGATOR

• Hatice Bozkurt Yavuz, MD

  Karadeniz Technical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: January 13, 2021
• First Posted: January 15, 2021
• Study Start: March 29, 2018
• Primary Completion: March 25, 2020
• Study Completion: April 15, 2020
• Last Updated: January 15, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)