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

NCT ID: NCT04711564

Last Updated: 2021-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-03-29

Study Completion Date

2020-04-15

Brief Summary

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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

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Conditions

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Sepsis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Olive oil-based intravenous fat emulsions

Intervention Type OTHER

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)

Soybean-based intravenous fat emulsions

Intervention Type OTHER

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

Interventions

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Olive oil-based intravenous fat emulsions

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

Intervention Type OTHER

Soybean-based intravenous fat emulsions

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Turkish Society of Clinical Enteral and Parenteral Nutrition

OTHER

Sponsor Role collaborator

Karadeniz Technical University

OTHER

Sponsor Role lead

Responsible Party

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Hulya ULUSOY

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Melda Kangalgil, MSc

Role: PRINCIPAL_INVESTIGATOR

Karadeniz Technical University

Ahmet Oguzhan Kucuk, MD

Role: PRINCIPAL_INVESTIGATOR

Karadeniz Technical University

Asiye Ozdemir, MD

Role: PRINCIPAL_INVESTIGATOR

Karadeniz Technical University

Süleyman Caner Karahan, MD

Role: PRINCIPAL_INVESTIGATOR

Karadeniz Technical University

Umitcan Ok, MD

Role: PRINCIPAL_INVESTIGATOR

Karadeniz Technical University

Hatice Bozkurt Yavuz, MD

Role: PRINCIPAL_INVESTIGATOR

Karadeniz Technical University

Locations

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Karadeniz Technical University Medical Faculty Department of Anesthesiology and Reanimation

Trabzon, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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23618724

Identifier Type: -

Identifier Source: org_study_id

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