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CompletedNCT04226430Updated Jan 13, 2020

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

An observational study in Sepsis and Cytokine Storm, sponsored by University of Gaziantep. Completed. Per ClinicalTrials.gov, last updated 2020-01-13.

Sponsored by University of Gaziantep · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
34
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Sepsis
  • Cytokine Storm

Keywords

  • Endocan
  • Copeptin
  • Interleukin-6
  • Cytosorb
  • Sepsis
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In context

Sepsis

1,899 studies on the registry are indexed under Sepsis; 462 are open to participants now.

This study's enrollment of 34 is below the median of 160 across 931 observational studies indexed under Sepsis.

Browse Sepsis studies →

Lead sponsor

University of Gaziantep is the lead sponsor of 100 studies on the registry; 26 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

Exclusion Criteria:

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

Observational model
Case-control
Time perspective
Prospective
Enrollment
34 participants (actual)
Target follow-up
1 Day
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

  • DeviceCytokine 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.

    Also known as: Cytosorb

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 13 months

  2. 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.

    Time frame: 13 months

  3. 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.

    Time frame: 13 months

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No — All data included in the manuscript that will be published.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 13, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04226430
Lead sponsor
University of Gaziantep
Responsible party
Berna Kaya Ugur (Assistan Professor, University of Gaziantep) — Principal investigator
First posted
Jan 13, 2020
Start date
Jun 1, 2016
Primary completion
Jun 30, 2017
Completion
Jun 30, 2017
Last update
Jan 13, 2020

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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