NCT04226430

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

Effect of a Novel Extracorporeal Cytokine Apheresis Method on Endocan, Copeptin and Interleukin-6 Levels in Sepsis: an Observational Prospective Study.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 34 (actual)
• Sponsor: University of Gaziantep · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Sepsis
• Cytokine Storm

Interventions

Type	Name	Description
DEVICE	Cytokine aphaeresis	The Cytosorb cartridge was either used alone in hemoperfusion mode or, if renal replacement therapy was clinically indicated, inserted proximally into a conventional continuous veno-venous hemofiltration (CVVH) or continuous veno-venous hemodiafiltration (CVVHDF) circuit. Before the start of the Cytosorb therapy, adequate anti-coagulation was confirmed when target partial thromboplastin time (PTT) of 60±80 seconds, or an activated clotting time (ACT) of 180±210 seconds was achieved with systemic heparin. Antibiotics were administered after each Cytosorb therapy whenever possible.

Timeline

• Start date: 2016-06-01
• Primary completion: 2017-06-30
• Completion: 2017-06-30
• First posted: 2020-01-13
• Last updated: 2020-01-13

Regulatory

• FDA-regulated device study