SIRSNCT04901338
Cytokine Hemoadsorption in ECMO Patients
An observational study of SIRS and Cytokine Storm, run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial summary
Cytokine hemoadsorption is a novel therapy used to improve outcome in critically ill patients with a dysregulated cytokine response and hemodynamic instability. Patients on extracorporeal membraneous oxygenation (ECMO) often develop severe systemic inflammatory response syndrome (SIRS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SIRS, Cytokine Storm, Cardiogenic Shock
- How many people
- 25 participants
- Where
- 1 siteSlovenia
- Study dates
- 1 Jun 2017to 31 Jan 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients on VA ECMO or VV ECMO treated with hemoadsorption
Who may be able to join
- VA/VV ECMO
- hemoadsorption
- Age ≥ 18 years
Who cannot join
- no additional exclusion criteria after being eligible for ECMO
Trial locations and contacts
1 site in 1 country.
About this study
Cytokine hemoadsorption is a novel therapy used to improve outcome in critically ill patients with a dysregulated cytokine response and hemodynamic instability. Patients on extracorporeal membraneous oxygenation (ECMO) often develop severe systemic inflammatory response syndrome (SIRS). Cytokine removal using different types of hemoadsorption devices is believed to block the vicious circle of inflammation dysregulation when other basic therapeutic measures fail. To date there are very limited reports on ECMO and cytokine hemoadsorption combination therapy. The aim of this retrospective study is to evaluate feasibility and effectiveness of hemoadsorption in veno-arterial and veno-venous ECMO patients.
- Conditions
- SIRS, Cytokine Storm, Cardiogenic Shock, Cardiac Arrest, Septic Shock, ARDS, Human
- Keywords
- Hemoadsorption, ECMO, SIRS, ARDS, Post-resuscitation syndrome, ECPR
- Medical subject headings
- Cytokine Release Syndrome, Shock, Cardiogenic, Heart Arrest, Shock, Septic, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Veno-arterial ECMO patients | Patients with severe SIRS post extracorporeal cardiopulmonary resuscitation (ECPR) or accompanying cardiogenic shock who were treated with hemoadsorption. | |
| Veno-venous ECMO patients | Patients with refractory septic shock on VV ECMO who were treated with hemoadsorption. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Haemodynamic stabilization
Decreased need for vasopressors according to vasoactive-inotropic score and increase in mean arterial pressure
Measured: Within 12 hours after hemoadsorption
Secondary outcomes (4)
Lactate, interleukin-6, C-reactive protein and procalcitonin clearance
Measured: Within 12 hours after hemoadsorption
Weaning from ECMO
Measured: from day of ECMO-implant for every 24 hours until date of weaning or death, whichever came first, assessed up to 90 days
ICU length of stay
Measured: from day of ICU-admission for every 24 hours until date of discharge or death, whichever came first, assessed up to 90 days
Hospital mortality
Measured: from day of hospital admission until date of discharge or death, whichever came first, assessed up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2021
- Study start1 Jun 2017
- Primary completion31 Jan 2021
- Study completion31 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SIRSStudies 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 only
- Time perspective
- Retrospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jernej Berden, University Medical Centre Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04901338
- Sponsor's protocol ID
- Haemoadsorption ECMO
- Status last verified
- May 2021
- First submitted
- 12 May 2021
- Last updated
- 25 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cytokine Hemoadsorption in ECMO Patients
- ClinicalTrials.gov ID
- NCT04901338
- Acronym / sponsor ID
- Haemoadsorption ECMO
- Conditions
- SIRS, Cytokine Storm, Cardiogenic Shock, Cardiac Arrest, Septic Shock, ARDS, Human
- Keywords
- Hemoadsorption, ECMO, SIRS, ARDS, Post-resuscitation syndrome, ECPR
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 31 Jan 2021 (actual)
- Study completion
- 31 Jan 2021 (actual)
- First posted
- 25 May 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.
Cytokine hemoadsorption is a novel therapy used to improve outcome in critically ill patients with a dysregulated cytokine response and hemodynamic instability. Patients on extracorporeal membraneous oxygenation (ECMO) often develop severe systemic inflammatory response syndrome (SIRS). Cytokine removal using different types of hemoadsorption devices is believed to block the vicious circle of inflammation dysregulation when other basic therapeutic measures fail. To date there are very limited reports on ECMO and cytokine hemoadsorption combination therapy. The aim of this retrospective study is to evaluate feasibility and effectiveness of hemoadsorption in veno-arterial and veno-venous ECMO patients.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Veno-arterial ECMO patients | – | –Patients with severe SIRS post extracorporeal cardiopulmonary resuscitation (ECPR) or accompanying cardiogenic shock who were treated with hemoadsorption. |
| Veno-venous ECMO patients | – | –Patients with refractory septic shock on VV ECMO who were treated with hemoadsorption. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients on VA ECMO or VV ECMO treated with hemoadsorption
Key inclusion criteria (3 listed)
- VA/VV ECMO
- hemoadsorption
- Age ≥ 18 years
Key exclusion criteria (1 listed)
- no additional exclusion criteria after being eligible for ECMO
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Haemodynamic stabilization
Time frame: Within 12 hours after hemoadsorption
Decreased need for vasopressors according to vasoactive-inotropic score and increase in mean arterial pressure
4 secondary outcomes
Lactate, interleukin-6, C-reactive protein and procalcitonin clearance
Time frame: Within 12 hours after hemoadsorption
Weaning from ECMO
Time frame: from day of ECMO-implant for every 24 hours until date of weaning or death, whichever came first, assessed up to 90 days
ICU length of stay
Time frame: from day of ICU-admission for every 24 hours until date of discharge or death, whichever came first, assessed up to 90 days
Hospital mortality
Time frame: from day of hospital admission until date of discharge or death, whichever came first, assessed up to 90 days
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 25 May 2021.
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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 SIRS and Cytokine Storm, run by University Medical Centre Ljubljana at 1 site in Slovenia.
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 1 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 25 May 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 Slovenia. 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?
Haemodynamic stabilization (time frame: Within 12 hours after hemoadsorption). 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 25 May 2021.