Effect of Cytosorb on Blood Levels of Inflammatory Biomarkers of Sepsis.

Completed

• Conditions: Cytokine Storm; Sepsis
• Interventions: Device: Cytokine aphaeresis

• Registration Number: NCT04226430
• Lead Sponsor: University of Gaziantep

Brief Summary

Background: There is still an evident need for useful biomarkers and effective therapeutic approaches regarding the challenging management of sepsis. The aim of the study is to evaluate the effect of each Cytosorb hemoadsorption therapy course on blood levels of inflammatory biomarkers of sepsis including endocan, copeptin, interleukin-6, procalcitonin, C-reactive protein.

Detailed Description

This observational prospective study included patients, who were diagnosed with sepsis and treated in the reanimation ICU of Gaziantep University Hospital with Cytosorb therapy between June 1st, 2016 and June 30th, 2017. Sepsis was diagnosed according to The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3).

Exclusion criteria of the study were: (i) cardiovascular disease, (ii) multiple traumas, (iii) malignancies, (v) incomplete clinical data.

Approval of the ethical committee (ethical committee approval number 2018/04-02) was obtained. Written informed consent was taken from each patient or their next-of-kin. Patient demographics including age, gender, and origin of sepsis were recorded. Arterial blood samples were taken from patients before and immediately after the Cytosorb therapy course.

Study Timeline

• Study Start: 2016-06-01
• Primary Completion: 2017-06-30
• Study Completion: 2017-06-30
• Status Verified: 2020-01
• Study First Submitted: 2020-01-07
• Study First Submitted QC: 2020-01-08
• Last Update Submitted: 2020-01-08
• Study First Posted: 2020-01-13
• Last Update Posted: 2020-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

• Patients, who were diagnosed with sepsis and treated in the reanimation ICU of Gaziantep University Hospital with Cytosorb therapy (Sepsis was diagnosed according to The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3))

Exclusion Criteria

• cardiovascular disease,
• multiple traumas
• malignancies
• incomplete clinical data.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
after cytosorb	Cytokine aphaeresis	Arterial blood samples were taken from patients immediately after the Cytosorb therapy course.
Before cytosorb	Cytokine aphaeresis	Arterial blood samples were taken from patients before the Cytosorb therapy course.

Primary Outcome Measures

Name	Time	Method
Effect of a novel extracorporeal cytokine apheresis method on endocan levels in sepsis	13 months	The effect of each Cytosorb hemoadsorption therapy course on blood levels of endocan, an inflammatory biomarker of sepsis.
Effect of a novel extracorporeal cytokine apheresis method on copeptin levels in sepsis	13 months	The effect of each Cytosorb hemoadsorption therapy course on blood levels of copeptin, an inflammatory biomarker of sepsis.
Effect of a novel extracorporeal cytokine apheresis method on interleukin-6 levels in sepsis	13 months	The effect of each Cytosorb hemoadsorption therapy course on blood levels of interleukin-6, an inflammatory biomarker of sepsis.