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

NCT04226430 | Completed FDA Device

• 1 other identifier: TF.18.43
• Study Type: observational
• Target: 34
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Sepsis; Cytokine Storm

Keywords

Endocan; Copeptin; Interleukin-6; Cytosorb; Sepsis

Outcome Measures

Primary Outcomes (3)

• Effect of a novel extracorporeal cytokine apheresis method on endocan levels in sepsis

  The effect of each Cytosorb hemoadsorption therapy course on blood levels of endocan, an inflammatory biomarker of sepsis.

  13 months

• Effect of a novel extracorporeal cytokine apheresis method on copeptin levels in sepsis

  The effect of each Cytosorb hemoadsorption therapy course on blood levels of copeptin, an inflammatory biomarker of sepsis.

  13 months

• Effect of a novel extracorporeal cytokine apheresis method on interleukin-6 levels in sepsis

  The effect of each Cytosorb hemoadsorption therapy course on blood levels of interleukin-6, an inflammatory biomarker of sepsis.

  13 months

Study Arms (2)

Before cytosorb

Arterial blood samples were taken from patients before the Cytosorb therapy course.

Device: Cytokine aphaeresis

after cytosorb

Arterial blood samples were taken from patients immediately after the Cytosorb therapy course.

Device: Cytokine aphaeresis

Interventions

Cytokine aphaeresis DEVICE

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.

Also known as: Cytosorb

Before cytosorb; after cytosorb

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This observational prospective study included patients, who were diagnosed with sepsis and treated in the reanimation ICU of Gaziantep University Hospital.

You may qualify if:

• 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))

You may not qualify if:

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

Sponsors & Collaborators

• University of Gaziantep: lead

Biospecimen

Retention: SAMPLES WITH DNA

Sera obtained from arterial blood

MeSH Terms

Conditions

Sepsis; Cytokine Release Syndrome; Diabetes Insipidus

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Pituitary Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistan Professor

Study Record Dates

• First Submitted: January 7, 2020
• First Posted: January 13, 2020
• Study Start: June 1, 2016
• Primary Completion: June 30, 2017
• Study Completion: June 30, 2017
• Last Updated: January 13, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share