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

January 8, 2020 updated by: Berna Kaya Ugur, University of Gaziantep

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

34

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Before cytosorb
Arterial blood samples were taken from patients before the Cytosorb therapy course.
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.
Other Names:
  • Cytosorb
after cytosorb
Arterial blood samples were taken from patients immediately after the Cytosorb therapy course.
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.
Other Names:
  • Cytosorb

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 1, 2016

Primary Completion (ACTUAL)

June 30, 2017

Study Completion (ACTUAL)

June 30, 2017

Study Registration Dates

First Submitted

January 7, 2020

First Submitted That Met QC Criteria

January 8, 2020

First Posted (ACTUAL)

January 13, 2020

Study Record Updates

Last Update Posted (ACTUAL)

January 13, 2020

Last Update Submitted That Met QC Criteria

January 8, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

All data included in the manuscript that will be published.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Sepsis

Clinical Trials on Cytokine aphaeresis

3
Subscribe