SepsisNCT04226430
Effect of Cytosorb on Blood Levels of Inflammatory Biomarkers of Sepsis.
An observational study of Sepsis and Cytokine Storm, run by University of Gaziantep.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sepsis, Cytokine Storm
- What is being tested?
- Cytokine aphaeresis
- Type of treatment
- Medical device
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2016to 30 Jun 2017
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This observational prospective study included patients, who were diagnosed with sepsis and treated in the reanimation ICU of Gaziantep University Hospital.
Who may be able to join
- 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))
Who cannot join
- cardiovascular disease,
- multiple traumas
- malignancies
- incomplete clinical data.
About this study
Official title: 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.
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.
- Conditions
- Sepsis, Cytokine Storm
- Being tested
- Cytokine aphaeresis
- Keywords
- Endocan, Copeptin, Interleukin-6, Cytosorb, Sepsis
- Medical subject headings
- Sepsis, Cytokine Release Syndrome, Diabetes Insipidus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cytokine aphaeresisDevice
Also called Cytosorb
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.
| Study group | Role | What they receive |
|---|---|---|
| Before cytosorb | Arterial blood samples were taken from patients before the Cytosorb therapy course. Receives: Device: Cytokine aphaeresis | |
| after cytosorb | Arterial blood samples were taken from patients immediately after the Cytosorb therapy course. Receives: Device: Cytokine aphaeresis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start1 Jun 2016
- Primary completion30 Jun 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 34 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- University of Gaziantep
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Berna Kaya Ugur, University of Gaziantep
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04226430
- Sponsor's protocol ID
- TF.18.43
- Status last verified
- Jan 2020
- First submitted
- 7 Jan 2020
- Last updated
- 13 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: All data included in the manuscript that will be published.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Novel Extracorporeal Cytokine Apheresis Method on Endocan, Copeptin and Interleukin-6 Levels in Sepsis: an Observational Prospective Study.
- ClinicalTrials.gov ID
- NCT04226430
- Acronym / sponsor ID
- TF.18.43
- Conditions
- Sepsis, Cytokine Storm
- Keywords
- Endocan, Copeptin, Interleukin-6, Cytosorb, Sepsis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of GaziantepUniversity, hospital or other
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 13 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Before cytosorb | – | Device: Cytokine aphaeresisArterial blood samples were taken from patients before the Cytosorb therapy course. |
| after cytosorb | – | Device: Cytokine aphaeresisArterial blood samples were taken from patients immediately after the Cytosorb therapy course. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This observational prospective study included patients, who were diagnosed with sepsis and treated in the reanimation ICU of Gaziantep University Hospital.
Key inclusion criteria (1 listed)
- 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))
Key exclusion criteria (4 listed)
- cardiovascular disease,
- multiple traumas
- malignancies
- incomplete clinical data.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cytokine aphaeresisAlso: CytosorbThe 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. | Device | Before cytosorb, after cytosorb |
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
- Individual participant dataSharing planned: No. All data included in the manuscript that will be published.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Cytokine Storm, run by University of Gaziantep.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of a novel extracorporeal cytokine apheresis method on endocan levels in sepsis (time frame: 13 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2020.