Cardiac ArrestCYTERNCT03685383
Cytokine Adsorption in Post-cardiac Arrest Syndrome in Patients Requiring Extracorporeal Cardiopulmonary Resuscitation
A study testing Cytosorb removal column in eCPR and standard eCPR (va-ECMO) in people with Cardiac Arrest and Extracorporeal Circulation, run by University Hospital Freiburg at 1 site in Germany.
Trial summary
Almost all patients with refractory cardiac arrest, who are primarily stabilized under ongoing cardiopulmonary resuscitation by transcutaneous implantation of a venoarterial extracorporeal membrane oxygenation system (va-ECMO for eCPR) develop post-cardiac arrest syndrome (PCAS). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cardiac Arrest, Extracorporeal Circulation, Extracorporeal Membrane Oxygenation
- What is being tested?
- Cytosorb removal column in eCPR and standard eCPR (va-ECMO)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteGermany
- Study dates
- 25 Sep 2019to 8 Dec 2020
- Phase
- Interventional
- 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
Who may be able to join
- All patients admitted to our ICU after successful CPR undergoing eCPR will be included in the trial.
Who cannot join
- The single exclusion criteria for the trial is, if decision has been made before admission to our ICU to terminate treatment within the next 24 hours.
Trial locations and contacts
1 site in 1 country.
About this study
Almost all patients with refractory cardiac arrest, who are primarily stabilized under ongoing cardiopulmonary resuscitation by transcutaneous implantation of a venoarterial extracorporeal membrane oxygenation system (va-ECMO for eCPR) develop post-cardiac arrest syndrome (PCAS). PCAS is characterised by cytokine storm resulting in vasodilation and membrane leakage, which is poorly controlled and often fatal. Case reports and data from the investigators' single-center registry indicate that cytokine adsorption with the CytoSorb removal column can be safely added to va-ECMO, but its efficacy and safety have not been examined systematically. This pilot study will assign all comers undergoing eCPR to va-ECMO with or without cytokine adsorber in a 1:1 fashion. This will ensure comparability and allow analysing clinical endpoints, but is limited by sample size (according to their experience the investigators expect approximately 20 cases per year). The investigators will however be able to generate important data about safety, secondary endpoints such as Interleukin-6-removal or vasopressor use and low-power data about efficacy concerning the primary endpoint 30-day survival.
Read the detailed description
Survival after out-of-hospital cardiac arrest (OHCA) as well as intra-hospital cardiac arrest (IHCA) is poor and remains on low levels over the past decades. Introduction of eCPR has promised to improve survival, however, so far there is no supporting data for this claim. In a recent registry study at the investigators' hospital they determined survival rates of 8.5% (OHCA) and 18.9% (IHCA), respectively. Almost all patients with refractory cardiac arrest, who are primarily stabilized under ongoing cardiopulmonary resuscitation by transcutaneous implantation of a veno-arterial extracorporeal membrane oxygenation system (va-ECMO for eCPR) develop post-cardiac arrest syndrome (PCAS). PCAS is characterised by cytokine storm resulting in vasodilation and membrane leakage, which is poorly controlled and often fatal. Case reports and data from the investigators' single-center registry indicate that cytokine adsorption with the CytoSorb removal column can be safely added to va-ECMO, but its efficacy and safety have not been examined systematically.
First, the investigators aim to assess the influence of treatment with the CytoSorb removal column over 72 hours after cardiac arrest and resuscitation using eCPR on 30-day-survival. As secondary endpoints, the investigators will assess the efficacy of Interleukin-6-removal, vasopressor-use and fluid-substitution, the latter two as a subsidiary of the degree of PCAS. Finally, the investigators will asses the safety of the use of the CytoSorb column in eCPR/va-ECMO.
The investigators hypothesize that the use of the CytoSorb column in eCPR/va-ECMO is a safe and efficient means to manage the consequences of PCAS and thus reduce 30-day mortality after eCPR.
All patients admitted to the investigators' hospital after successful CPR and implantation of va-ECMO/ ECLS (extracorporeal life support, eCPR) will be included in the trial. In a 1:1 manner participants will be assigned to the intervention and control groups.
Experimental intervention:
In addition to standard treatment in patients undergoing eCPR in the intervention group the CytoSorb removal column will be added to the ECLS-system.
Control intervention:
Patients in the control group will receive standard treatment established for eCPR patients on our ICU. This standard treatment includes, among others, targeted temperature management (TTM) for the first 72 hours. For the use of ECLS as well as TTM we are following well established standard operating procedures.
Duration of intervention per patient:
The duration of the intervention will be 72 hours. Each CytoSorb removal column can be used for 24 hours, so all patients in the intervention group will receive 3 subsequent filters during the study period.
Follow-up per patient:
The follow-up period for each patient in the trial will be 30 days.
Key inclusion criteria:
All patients admitted to our ICU after successful CPR undergoing eCPR will be included in the trial.
Key exclusion criteria:
The single exclusion criteria for the trial is, if decision has been made before admission to our ICU to terminate treatment within the next 24 hours.
- Conditions
- Cardiac Arrest, Extracorporeal Circulation, Extracorporeal Membrane Oxygenation, Cytokine Storm, Cytokine Release Syndrome, Post-Cardiac Arrest Syndrome
- Being tested
- Cytosorb removal column in eCPR, standard eCPR (va-ECMO)
- Keywords
- Extracorporeal Circulation, Extracorporeal Membrane Oxygenation, Cytokine Adsorption, Post-Cardiac Arrest Syndrome, Cardiac Arrest, Cardio-Pulmonary Resuscitation
- Medical subject headings
- Heart Arrest, Cytokine Release Syndrome, Post-Cardiac Arrest Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cytosorb removal column in eCPRDevice
In addition to standard treatment in eCPR in the study group a CytoSorb removal column is added to the va-ECMO system for the prevention of post-cardiac arrest syndrome.
standard eCPR (va-ECMO)Device
Standard treatment in eCPR with a established va-ECMO system.
| Study group | Role | What they receive |
|---|---|---|
| intervention group: eCPR + CytoSorb | Experimental | In addition to standard treatment in patients undergoing eCPR in the intervention group the CytoSorb removal column will be added to the ECLS-system (intervention: CytoSorb removal column in eCPR). Receives: Device: Cytosorb removal column in eCPR |
| control group: eCPR - CytoSorb | Active comparator | Patients in the control group will receive standard treatment established for eCPR patients on our ICU. This standard treatment includes, among others, targeted temperature management (TTM) for the first 72 hours. For the use of ECLS as well as TTM we are following well established standard operating procedures (control: standard eCPR (va-ECMO)). Receives: Device: standard eCPR (va-ECMO) |
What is being measured
The primary outcome is the main question the study is designed to answer.
survival after 30 days
rate of survival after 30 days after eCPR
Measured: 30 days
Secondary outcomes (5)
secondary outcome measure: cytokine-clearance
Interleukin-6 level (patient blood)
Measured: 72 hours
secondary outcome measure: vasopressor use
vasopressor-use (µg/h/kg bodyweight)
Measured: 72 hours
secondary outcome measure: fluid substitution
fluid substitution (ml/h/kg bodyweight)
Measured: 72 hours
secondary outcome measure: renal function
serum creatinin level
Measured: 72 hours
secondary outcome measure: serum-lactate
serum-lactate level
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2018
- Study start25 Sep 2019
- Primary completion8 Dec 2020
- Study completion8 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac ArrestStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- two-groups (treatment vs. control), pseudo-randomized, monocentric, nonblinded
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Freiburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Duerschmied, University Hospital Freiburg
- Investigators
- Daniel Duerschmied, Prof. Dr., Principal investigator, University of Freiburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03685383
- Sponsor's protocol ID
- CYTER_SC_2018
- Acronym
- CYTER
- Status last verified
- Mar 2021
- First submitted
- 5 Sep 2018
- Last updated
- 15 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Supady A, Zahn T, Kuhl M, Maier S, Benk C, Kaier K, Bottiger BW, Bode C, Lother A, Staudacher DL, Wengenmayer T, Duerschmied D. Cytokine adsorption in patients with post-cardiac arrest syndrome after extracorporeal cardiopulmonary resuscitation (CYTER) - A single-centre, open-label, randomised, controlled trial. Resuscitation. 2022 Apr;173:169-178. doi: 10.1016/j.resuscitation.2022.02.001. Epub 2022 Feb 7.
PubMed 35143902
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cytokine Adsorption in Post-cardiac Arrest Syndrome in Patients Requiring Extracorporeal Cardiopulmonary Resuscitation
- ClinicalTrials.gov ID
- NCT03685383
- Acronym / sponsor ID
- CYTER / CYTER_SC_2018
- Conditions
- Cardiac Arrest, Extracorporeal Circulation, Extracorporeal Membrane Oxygenation, Cytokine Storm, Cytokine Release Syndrome, Post-Cardiac Arrest Syndrome
- Keywords
- Extracorporeal Circulation, Extracorporeal Membrane Oxygenation, Cytokine Adsorption, Post-Cardiac Arrest Syndrome, Cardiac Arrest, Cardio-Pulmonary Resuscitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University Hospital FreiburgUniversity, hospital or other
- Study start
- 25 Sep 2019 (actual)
- Primary completion
- 8 Dec 2020 (actual)
- Study completion
- 8 Dec 2020 (actual)
- First posted
- 26 Sep 2018 (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.
Almost all patients with refractory cardiac arrest, who are primarily stabilized under ongoing cardiopulmonary resuscitation by transcutaneous implantation of a venoarterial extracorporeal membrane oxygenation system (va-ECMO for eCPR) develop post-cardiac arrest syndrome (PCAS). PCAS is characterised by cytokine storm resulting in vasodilation and membrane leakage, which is poorly controlled and often fatal. Case reports and data from the investigators' single-center registry indicate that cytokine adsorption with the CytoSorb removal column can be safely added to va-ECMO, but its efficacy and safety have not been examined systematically. This pilot study will assign all comers undergoing eCPR to va-ECMO with or without cytokine adsorber in a 1:1 fashion. This will ensure comparability and allow analysing clinical endpoints, but is limited by sample size (according to their experience the investigators expect approximately 20 cases per year). The investigators will however be able to generate important data about safety, secondary endpoints such as Interleukin-6-removal or vasopressor use and low-power data about efficacy concerning the primary endpoint 30-day survival.
Detailed description
Survival after out-of-hospital cardiac arrest (OHCA) as well as intra-hospital cardiac arrest (IHCA) is poor and remains on low levels over the past decades. Introduction of eCPR has promised to improve survival, however, so far there is no supporting data for this claim. In a recent registry study at the investigators' hospital they determined survival rates of 8.5% (OHCA) and 18.9% (IHCA), respectively. Almost all patients with refractory cardiac arrest, who are primarily stabilized under ongoing cardiopulmonary resuscitation by transcutaneous implantation of a veno-arterial extracorporeal membrane oxygenation system (va-ECMO for eCPR) develop post-cardiac arrest syndrome (PCAS). PCAS is characterised by cytokine storm resulting in vasodilation and membrane leakage, which is poorly controlled and often fatal. Case reports and data from the investigators' single-center registry indicate that cytokine adsorption with the CytoSorb removal column can be safely added to va-ECMO, but its efficacy and safety have not been examined systematically.
First, the investigators aim to assess the influence of treatment with the CytoSorb removal column over 72 hours after cardiac arrest and resuscitation using eCPR on 30-day-survival. As secondary endpoints, the investigators will assess the efficacy of Interleukin-6-removal, vasopressor-use and fluid-substitution, the latter two as a subsidiary of the degree of PCAS. Finally, the investigators will asses the safety of the use of the CytoSorb column in eCPR/va-ECMO.
The investigators hypothesize that the use of the CytoSorb column in eCPR/va-ECMO is a safe and efficient means to manage the consequences of PCAS and thus reduce 30-day mortality after eCPR.
All patients admitted to the investigators' hospital after successful CPR and implantation of va-ECMO/ ECLS (extracorporeal life support, eCPR) will be included in the trial. In a 1:1 manner participants will be assigned to the intervention and control groups.
Experimental intervention:
In addition to standard treatment in patients undergoing eCPR in the intervention group the CytoSorb removal column will be added to the ECLS-system.
Control intervention:
Patients in the control group will receive standard treatment established for eCPR patients on our ICU. This standard treatment includes, among others, targeted temperature management (TTM) for the first 72 hours. For the use of ECLS as well as TTM we are following well established standard operating procedures.
Duration of intervention per patient:
The duration of the intervention will be 72 hours. Each CytoSorb removal column can be used for 24 hours, so all patients in the intervention group will receive 3 subsequent filters during the study period.
Follow-up per patient:
The follow-up period for each patient in the trial will be 30 days.
Key inclusion criteria:
All patients admitted to our ICU after successful CPR undergoing eCPR will be included in the trial.
Key exclusion criteria:
The single exclusion criteria for the trial is, if decision has been made before admission to our ICU to terminate treatment within the next 24 hours.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- two-groups (treatment vs. control), pseudo-randomized, monocentric, nonblinded
| Arm | Type | Receives |
|---|---|---|
| intervention group: eCPR + CytoSorb | Experimental | Device: Cytosorb removal column in eCPRIn addition to standard treatment in patients undergoing eCPR in the intervention group the CytoSorb removal column will be added to the ECLS-system (intervention: CytoSorb removal column in eCPR). |
| control group: eCPR - CytoSorb | Active comparator | Device: standard eCPR (va-ECMO)Patients in the control group will receive standard treatment established for eCPR patients on our ICU. This standard treatment includes, among others, targeted temperature management (TTM) for the first 72 hours. For the use of ECLS as well as TTM we are following well established standard operating procedures (control: standard eCPR (va-ECMO)). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients admitted to our ICU after successful CPR undergoing eCPR will be included in the trial.
Key exclusion criteria (1 listed)
- The single exclusion criteria for the trial is, if decision has been made before admission to our ICU to terminate treatment within the next 24 hours.
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 |
|---|---|---|
| Cytosorb removal column in eCPRIn addition to standard treatment in eCPR in the study group a CytoSorb removal column is added to the va-ECMO system for the prevention of post-cardiac arrest syndrome. | Device | intervention group: eCPR + CytoSorb |
| standard eCPR (va-ECMO)Standard treatment in eCPR with a established va-ECMO system. | Device | control group: eCPR - CytoSorb |
Primary outcome
survival after 30 days
Time frame: 30 days
rate of survival after 30 days after eCPR
5 secondary outcomes
secondary outcome measure: cytokine-clearance
Time frame: 72 hours
secondary outcome measure: vasopressor use
Time frame: 72 hours
secondary outcome measure: fluid substitution
Time frame: 72 hours
secondary outcome measure: renal function
Time frame: 72 hours
secondary outcome measure: serum-lactate
Time frame: 72 hours
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 15 Mar 2021.
- Derived from this study: PubMed 35143902Supady A, Zahn T, Kuhl M, Maier S, Benk C, Kaier K, Bottiger BW, Bode C, Lother A, Staudacher DL, Wengenmayer T, Duerschmied D. Cytokine adsorption in patients with post-cardiac arrest syndrome after extracorporeal cardiopulmonary resuscitation (CYTER) - A single-centre, open-label, randomised, controlled trial. Resuscitation. 2022 Apr;173:169-178. doi: 10.1016/j.resuscitation.2022.02.001. Epub 2022 Feb 7.
- 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.
Daniel Duerschmied, Prof. Dr. principal investigator
University of Freiburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cytosorb removal column in eCPR and standard eCPR (va-ECMO) in people with Cardiac Arrest and Extracorporeal Circulation, run by University Hospital Freiburg at 1 site in Germany.
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 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 15 Mar 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 Germany. 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?
survival after 30 days (time frame: 30 days). 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 NCT03685383, which also lists 1 linked publication.
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 15 Mar 2021.