Interleukin-6NCT05057455
Effectiveness of the Cytokine Hemadsorption on Sepsis
An observational study of Interleukin-6, run by Biruni University at 1 site in Turkey (Türkiye).
Trial summary
In this prospective study, we aimed to compare the laboratory and clinical results of cytokine hemadsorption as an immunomodulation therapy in ICU patients diagnosed with sepsis or septic shock. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Interleukin-6
- What is being tested?
- cytokine hemadsorption
- Type of treatment
- Surgery or procedure
- How many people
- 39 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2020to 15 Feb 2021
- 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 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: In this one-centered study, we prospectively analyzed the outcomes and laboratory findings of 39 patients diagnosed with sepsis from 01 Jan 2020 to 30 December 2020 hospitalized in ICU.
Who may be able to join
- the patients were the available data of clinical and laboratory diagnosis of sepsis and septic shock
- detection of gram-negative bacterial agent in blood or sputum culture.
- patients who had the shock symptoms such as hypotension, tachycardia or fever during the course of sepsis.
Who cannot join
- had uncontrolled hemorrhage,
- diagnosed with cardiac failure at stage 4 or renal failure at stage 4 or hepatic liver failure at stage 4
- cancer at the end stage or admitted with acute coronary syndrome.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of the Cytokine Hemadsorption on the Clinical Progression and Mortality of Intensive Care Patients With Sepsis
In this prospective study, we aimed to compare the laboratory and clinical results of cytokine hemadsorption as an immunomodulation therapy in ICU patients diagnosed with sepsis or septic shock.
- Conditions
- Interleukin-6
- Being tested
- cytokine hemadsorption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cytokine hemadsorptionProcedure or surgery
the laboratory and clinical results of cytokine hemadsorption as an immunomodulation therapy in ICU patients diagnosed with sepsis or septic shock.
| Study group | Role | What they receive |
|---|---|---|
| ICU patients diagnosed with sepsis or septic shock | compare the laboratory and clinical results of cytokine hemadsorption as an immunomodulation therapy in ICU patients diagnosed with sepsis or septic shock. Receives: Procedure: cytokine hemadsorption |
What is being measured
The primary outcome is the main question the study is designed to answer.
IL-6
levels of IL-6
Measured: 1 YEARS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2021
- Study start1 Jan 2020
- Primary completion30 Dec 2020
- Study completion15 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Interleukin-6Studies of the same condition, open and under way.
- More trials run by Biruni UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biruni University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, IKUPELI, Biruni University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05057455
- Sponsor's protocol ID
- BIRUNI 2
- Status last verified
- Sep 2021
- First submitted
- 16 Sep 2021
- Last updated
- 27 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bahar I, Oksuz H, Senoglu N, Demirkiran H, Aydogan M, Tomak Y, Comez M, Bayrakci S, Gonullu E, Berktas M. Compliance With the Surviving Sepsis Campaign Bundle: A Multicenter Study From Turkey. Cureus. 2021 May 12;13(5):e14989. doi: 10.7759/cureus.14989.
PubMed 34131534Houschyar KS, Pyles MN, Rein S, Nietzschmann I, Duscher D, Maan ZN, Weissenberg K, Philipps HM, Strauss C, Reichelt B, Siemers F. Continuous hemoadsorption with a cytokine adsorber during sepsis - a review of the literature. Int J Artif Organs. 2017 May 29;40(5):205-211. doi: 10.5301/ijao.5000591. Epub 2017 May 19.
PubMed 28525674Ye Q, Wang B, Mao J. The pathogenesis and treatment of the ;Cytokine Storm' in COVID-19. J Infect. 2020 Jun;80(6):607-613. doi: 10.1016/j.jinf.2020.03.037. Epub 2020 Apr 10.
PubMed 32283152Bonavia A, Groff A, Karamchandani K, Singbartl K. Clinical Utility of Extracorporeal Cytokine Hemoadsorption Therapy: A Literature Review. Blood Purif. 2018;46(4):337-349. doi: 10.1159/000492379. Epub 2018 Sep 3.
PubMed 30176653
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of the Cytokine Hemadsorption on the Clinical Progression and Mortality of Intensive Care Patients With Sepsis
- ClinicalTrials.gov ID
- NCT05057455
- Acronym / sponsor ID
- BIRUNI 2
- Conditions
- Interleukin-6
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Biruni UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 15 Feb 2021 (actual)
- First posted
- 27 Sep 2021 (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.
In this prospective study, we aimed to compare the laboratory and clinical results of cytokine hemadsorption as an immunomodulation therapy in ICU patients diagnosed with sepsis or septic shock.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICU patients diagnosed with sepsis or septic shock | – | Procedure: cytokine hemadsorptioncompare the laboratory and clinical results of cytokine hemadsorption as an immunomodulation therapy in ICU patients diagnosed with sepsis or septic shock. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In this one-centered study, we prospectively analyzed the outcomes and laboratory findings of 39 patients diagnosed with sepsis from 01 Jan 2020 to 30 December 2020 hospitalized in ICU.
Key inclusion criteria (3 listed)
- the patients were the available data of clinical and laboratory diagnosis of sepsis and septic shock
- detection of gram-negative bacterial agent in blood or sputum culture.
- patients who had the shock symptoms such as hypotension, tachycardia or fever during the course of sepsis.
Key exclusion criteria (3 listed)
- had uncontrolled hemorrhage,
- diagnosed with cardiac failure at stage 4 or renal failure at stage 4 or hepatic liver failure at stage 4
- cancer at the end stage or admitted with acute coronary syndrome.
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 hemadsorptionthe laboratory and clinical results of cytokine hemadsorption as an immunomodulation therapy in ICU patients diagnosed with sepsis or septic shock. | Procedure or surgery | ICU patients diagnosed with sepsis or septic shock |
Primary outcome
IL-6
Time frame: 1 YEARS
levels of IL-6
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 27 Sep 2021.
- Background: PubMed 34131534Bahar I, Oksuz H, Senoglu N, Demirkiran H, Aydogan M, Tomak Y, Comez M, Bayrakci S, Gonullu E, Berktas M. Compliance With the Surviving Sepsis Campaign Bundle: A Multicenter Study From Turkey. Cureus. 2021 May 12;13(5):e14989. doi: 10.7759/cureus.14989.
- Results publication: PubMed 28525674Houschyar KS, Pyles MN, Rein S, Nietzschmann I, Duscher D, Maan ZN, Weissenberg K, Philipps HM, Strauss C, Reichelt B, Siemers F. Continuous hemoadsorption with a cytokine adsorber during sepsis - a review of the literature. Int J Artif Organs. 2017 May 29;40(5):205-211. doi: 10.5301/ijao.5000591. Epub 2017 May 19.
- Results publication: PubMed 32283152Ye Q, Wang B, Mao J. The pathogenesis and treatment of the ;Cytokine Storm' in COVID-19. J Infect. 2020 Jun;80(6):607-613. doi: 10.1016/j.jinf.2020.03.037. Epub 2020 Apr 10.
- Results publication: PubMed 30176653Bonavia A, Groff A, Karamchandani K, Singbartl K. Clinical Utility of Extracorporeal Cytokine Hemoadsorption Therapy: A Literature Review. Blood Purif. 2018;46(4):337-349. doi: 10.1159/000492379. Epub 2018 Sep 3.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Interleukin-6, run by Biruni University at 1 site in Turkey (Türkiye).
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 3 inclusion and 3 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 27 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
IL-6 (time frame: 1 YEARS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05057455, which also lists 4 linked publications.
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 27 Sep 2021.