Cytokine Hemadsorption Therapy in Critically Ill Patients Who Have no Microbiological Findings and Develop Vasoplegic ShockNCT05984407
EFFECTS OF EXTRACORPOREAL CYTOKINE ELIMINATION ON HEMODYNAMIA AND MORTALITY IN CRITICAL PATIENTS
An observational study of Cytokine Hemadsorption Therapy in Critically Ill Patients Who Have no Microbiological Findings and Develop Vasoplegic Shock, run by Hakan Küçükkepeci at 1 site in Turkey (Türkiye).
Trial summary
Observation of the effects of cytokine adsorbent hemadsorption therapy on hemodynamics and mortality in critically ill patients who developed vasoplegic shock due to hyperinflammation without microbiological findings in the intensive care unit. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cytokine Hemadsorption Therapy in Critically Ill Patients Who Have no Microbiological Findings and Develop Vasoplegic Shock
- What is being tested?
- cytokine hemadsorption therapy
- Type of treatment
- Surgery or procedure
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2023to 1 Feb 2024
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Thirty patients who met the inclusion criteria were included in the study.
Who may be able to join
- C-reactive protein (CRP) ≥ 100 mg/l
- Procalcitonin (PCT) < 2 ng/l
- Patients aged 18-80 years who were treated with cytokine adsorption due to vasoplegic shock
Who cannot join
- Patients under 18 years of age
- Patients with suspected or proven bacterial cause of vasoplegic shock.
- Those who did not approve to participate in the study
- Patients without vasoplegic shock
- Patients with CRP < 100 mg/l, PCT ≥ 2 μg/L
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Prof. Dr. Cemil Taşcıoğlu City Hospital
Istanbul, Şişli, 34384
About this study
Observation of the effects of cytokine adsorbent hemadsorption therapy on hemodynamics and mortality in critically ill patients who developed vasoplegic shock due to hyperinflammation without microbiological findings in the intensive care unit.
Read the detailed description
Observation of the effects of cytokine adsorbent hemadsorption therapy on hemodynamics and mortality in critically ill patients who developed vasoplegic shock due to hyperinflammation without microbiological findings and met the inclusion criteria in the Intensive Care Unit between 01.08.2023 and 01.02.2024
- Being tested
- cytokine hemadsorption therapy
- Keywords
- vasoplegic shock, cytokine hemadsorption, hemodynamics, mortality, cytokine storm
- Medical subject headings
- Cytokine Release Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cytokine hemadsorption therapyProcedure or surgery
Observation of cytokine hemadsorption therapy in critically ill patients who have no microbiological findings and develop vasoplegic shock.
| Study group | Role | What they receive |
|---|---|---|
| patients with vasoplegic shock | Application of cytokine hemadsorption therapy in patients with vasoplegic shock without microbiological findings Receives: Procedure: cytokine hemadsorption therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The time to resolution of vasoplegic shock within days.
Measured: From enrollment to the end of treatment at 12 weeks
Secondary outcomes (13)
7-day mortality
Measured: 7 days
mortality until discharge from hospital
Measured: From enrollment to the end of treatment at 12 weeks
Interleukin 1 beta level on day 1
Measured: one day
Interleukin 10 level on day 1
Measured: one day
Interleukin 6 level on day 1
Measured: one day
TNF - α level on day 1
Measured: one day
Interleukin 1 beta level on day 3
Measured: 3 days
Interleukin 10 level on day 3
Measured: 3 days
Interleukin 6 level on day 3
Measured: 3 days
TNF - α level on day 3
Measured: 3 days
mechanical ventilation need and duration
Measured: From enrollment to the end of treatment at 12 weeks
duration of treatment in the intensive care unit
Measured: From enrollment to the end of treatment at 12 weeks
dose of catecholamine
Measured: From enrollment to the end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2023
- Study start1 Aug 2023
- Primary completion1 Nov 2023 (estimated)
- Study completion1 Feb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cytokine Hemadsorption Therapy in Critically Ill Patients Who Have no Microbiological Findings and Develop Vasoplegic ShockStudies 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hakan Küçükkepeci
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hakan Küçükkepeci, Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05984407
- Sponsor's protocol ID
- 652779
- Status last verified
- Aug 2023
- First submitted
- 2 Aug 2023
- Last updated
- 9 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECTS OF EXTRACORPOREAL CYTOKINE ELIMINATION ON HEMODYNAMIA AND MORTALITY IN CRITICAL PATIENTS
- ClinicalTrials.gov ID
- NCT05984407
- Acronym / sponsor ID
- 652779
- Keywords
- vasoplegic shock, cytokine hemadsorption, hemodynamics, mortality, cytokine storm
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Hakan KüçükkepeciUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 Nov 2023 (estimated)
- Study completion
- 1 Feb 2024 (estimated)
- First posted
- 9 Aug 2023 (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.
Observation of the effects of cytokine adsorbent hemadsorption therapy on hemodynamics and mortality in critically ill patients who developed vasoplegic shock due to hyperinflammation without microbiological findings in the intensive care unit.
Detailed description
Observation of the effects of cytokine adsorbent hemadsorption therapy on hemodynamics and mortality in critically ill patients who developed vasoplegic shock due to hyperinflammation without microbiological findings and met the inclusion criteria in the Intensive Care Unit between 01.08.2023 and 01.02.2024
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with vasoplegic shock | – | Procedure: cytokine hemadsorption therapyApplication of cytokine hemadsorption therapy in patients with vasoplegic shock without microbiological findings |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Thirty patients who met the inclusion criteria were included in the study.
Key inclusion criteria (3 listed)
- C-reactive protein (CRP) ≥ 100 mg/l
- Procalcitonin (PCT) < 2 ng/l
- Patients aged 18-80 years who were treated with cytokine adsorption due to vasoplegic shock
Key exclusion criteria (5 listed)
- Patients under 18 years of age
- Patients with suspected or proven bacterial cause of vasoplegic shock.
- Those who did not approve to participate in the study
- Patients without vasoplegic shock
- Patients with CRP < 100 mg/l, PCT ≥ 2 μg/L
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 hemadsorption therapyObservation of cytokine hemadsorption therapy in critically ill patients who have no microbiological findings and develop vasoplegic shock. | Procedure or surgery | patients with vasoplegic shock |
Primary outcome
The time to resolution of vasoplegic shock within days.
Time frame: From enrollment to the end of treatment at 12 weeks
13 secondary outcomes
7-day mortality
Time frame: 7 days
mortality until discharge from hospital
Time frame: From enrollment to the end of treatment at 12 weeks
Interleukin 1 beta level on day 1
Time frame: one day
Interleukin 10 level on day 1
Time frame: one day
Interleukin 6 level on day 1
Time frame: one day
TNF - α level on day 1
Time frame: one day
Interleukin 1 beta level on day 3
Time frame: 3 days
Interleukin 10 level on day 3
Time frame: 3 days
Interleukin 6 level on day 3
Time frame: 3 days
TNF - α level on day 3
Time frame: 3 days
mechanical ventilation need and duration
Time frame: From enrollment to the end of treatment at 12 weeks
duration of treatment in the intensive care unit
Time frame: From enrollment to the end of treatment at 12 weeks
dose of catecholamine
Time frame: From enrollment to the end of treatment at 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2023.
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 Cytokine Hemadsorption Therapy in Critically Ill Patients Who Have no Microbiological Findings and Develop Vasoplegic Shock, run by Hakan Küçükkepeci 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 5 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: status not confirmed, as of the sponsor's last update on 9 Aug 2023. 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?
Results are not available in the source record.
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?
The time to resolution of vasoplegic shock within days. (time frame: From enrollment to the end of treatment at 12 weeks). 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 9 Aug 2023.