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Completed

NCT Number: NCT04711564

The Effects of Different Lipid Emulsions on the Adipokines 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.

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Key information

Conditions

Sepsis Hyperphagia Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Systemic Inflammatory Response Syndrome

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Karadeniz Technical University Medical Faculty Department of Anesthesiology and Reanimation

Trabzon, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Olive oil-based intravenous fat emulsions

Other

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

Soybean-based intravenous fat emulsions

Other

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

Primary outcomes

  1. Change of the adipokine in the first ten days in onset sepsis

    Time frame: Baseline and 10 days

    Adipokines levels are assayed using a enzyme-linked immunosorbent assay

Secondary outcomes

  1. Intensive care unit length of stay

    Time frame: Time of admission to the ICU until the time of discharge from the intensive care unit, up to 1 year

    Time from study inclusion to intensive care unit discharge.

  2. 28-day mortality

    Time frame: 28 day

    Mortality rate

Sponsors and collaborators

Lead sponsor

Karadeniz Technical University

Other

Collaborators

  • Turkish Society of Clinical Enteral and Parenteral Nutrition

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jan 15, 2021
Registry last updated
Jan 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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