Cardiac ArrestCATCHNCT03523039
Hemoadsorption With CytoSorb® in Post-Cardiac Arrest Syndrome
A study testing CytoSorb® Hemoadsorption in people with Cardiac Arrest, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
Trial summary
This prospective single-centre randomized control trial aims at evaluating the safety and efficacy of hemoadsorption with CytoSorb® in 40 patients with Post-Cardiac Arrest Syndrome admitted to the ICU. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest
- What is being tested?
- CytoSorb® Hemoadsorption
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteSwitzerland
- Study dates
- 18 Feb 2019to 1 Mar 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Evidence for patient's refusal to participate in clinical trials
- Non commitment for ongoing medical therapy (imminent withdrawal of care)
- Cardiac arrest caused by hemorrhagic shock
- Contraindications to therapeutic heparinization
- Shock of primary cardiac origin (LVEF <20%)
- Platelet count <20 G/L
Show all 13Show fewer
- Deep immunosuppression state, as defined by neutrophils <1 G/L or CD4 <200 /mm3
- Pregnancy
- Acute sickle cell crisis
- Refractory cardiac arrest with ECMO implantation
- Need for renal replacement therapy at time of randomization
- Concomitant enrolment in another study
- Non availability of the research team at time of eligibility at time of randomization
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Centre Hospitalier Universitaire Vaudois
Lausanne, Canton of Vaud, 1011
About this study
Official title: Hemoadsorption With CytoSorb® in Post-Cardiac Arrest Syndrome: a Pilot Study (The CATCH Trial: Post Cardiac Arrest Therapy With Cytosorb Hemoadsorption)
This prospective single-centre randomized control trial aims at evaluating the safety and efficacy of hemoadsorption with CytoSorb® in 40 patients with Post-Cardiac Arrest Syndrome admitted to the ICU.
Read the detailed description
Patients presenting Post-Cardiac Arrest Syndrome (PCAS) in the 24 hours following their admission in Intensive Care Unit will be randomly assigned either to a control group (standard of care) either to a "Hemoadsorption" group. In the latter, the patient will be connected in the 6 hours following randomization to an extracorporeal circuit, in which a Cytosorb ® cartridge will be placed. The circuit will be set up in hemoperfusion mode. The therapy will take place for a minimum of 12 hours and a maximum of 24 hours. Anticoagulation will be achieved using a regional heparin-protamin regimen.
Blood samples will be collected at randomization, T1 (6 hours post-randomization), T2 (12 hours after randomization), T3 (24 hours after randomization), T4 (48 hours after randomization) and T5 (48 hours after randomization), to assess change in inflammatory cytokine levels.
- Conditions
- Cardiac Arrest
- Being tested
- CytoSorb® Hemoadsorption
- Keywords
- Cardiac Arrest, Cytokine Hemoadsorption
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CytoSorb® HemoadsorptionDevice
The therapy is initiated within 6 hours from randomization and maintained for a minimum of 12 consecutive hours to a maximum of 24 consecutive hours.
| Study group | Role | What they receive |
|---|---|---|
| Hemoadsorption | Experimental | Hemoadsorption is performed using a CytoSorb® cartridge. Receives: Device: CytoSorb® Hemoadsorption |
| Control | No intervention | Post-cardiac arrest management will be conducted as per institutional protocols. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cytokine levels
Plasma levels reduction of the following inflammatory mediators: IL-1β,IL-1Ra, IL-6, IL-8, IL-10 and TNF-α.
Measured: From baseline (randomization) to 72 hours after randomization
Incidence of Treatment-Emergent Adverse Events
Rate of intervention-related complications
Measured: From beginning of hemoadsorption to 24 hours after the end of hemoadsorption, incidence of adverse events such as haemorrhagic complications, catheter-insertion related complications and anaphylactoid reactions
Secondary outcomes (5)
Vasopressor requirements
Including the number of patients with a 50% decrease in the baseline vasopressor dose after 6, 12, 24, 36 and 48 hours, and the % of patients requiring a vasopressor dose increase within 24 hours of baseline
Measured: From baseline (randomization) to 72 hours after randomization
In-hospital mortality
All-cause mortality
Measured: Day 14, 28 and 90 after randomization
Shock reversal
Percentage of patients with shock reversal shock reversal being defined in the present study as a norepinephrine dose <0.1μg/kg/min to maintain MAP >60-70 mmHg and a serum lactate level ≤2 mmol/L
Measured: Within 24 hours from randomization
Sequential Organ Failure Assessment Score (SOFA)
Total Daily SOFA Score. The score ranges from 0 (best outcome) to 24 (worst outcome).
Measured: Day 1 to 7 after randomization
CRP and Procalcitonin Levels
Measured: Day 1, 2, 3 after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2018
- Study start18 Feb 2019
- Primary completion1 Dec 2021
- Study completion1 Mar 2022
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.
- More trials run by Centre Hospitalier Universitaire VaudoisThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Antoine Schneider, Centre Hospitalier Universitaire Vaudois
- Investigators
- Antoine Schneider, MD, PhD, Principal investigator, Centre Hospitalier Universitaire Vaudois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03523039
- Sponsor's protocol ID
- ID 2018-00421
- Acronym
- CATCH
- Status last verified
- Mar 2022
- First submitted
- 19 Apr 2018
- Last updated
- 14 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Monard C, Bianchi N, Poli E, Altarelli M, Debonneville A, Oddo M, Liaudet L, Schneider A. Cytokine hemoadsorption with CytoSorb(R) in post-cardiac arrest syndrome, a pilot randomized controlled trial. Crit Care. 2023 Jan 23;27(1):36. doi: 10.1186/s13054-023-04323-x.
PubMed 36691082
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemoadsorption With CytoSorb® in Post-Cardiac Arrest Syndrome: a Pilot Study (The CATCH Trial: Post Cardiac Arrest Therapy With Cytosorb Hemoadsorption)
- ClinicalTrials.gov ID
- NCT03523039
- Acronym / sponsor ID
- CATCH / ID 2018-00421
- Conditions
- Cardiac Arrest
- Keywords
- Cardiac Arrest, Cytokine Hemoadsorption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- Study start
- 18 Feb 2019 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 14 May 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.
This prospective single-centre randomized control trial aims at evaluating the safety and efficacy of hemoadsorption with CytoSorb® in 40 patients with Post-Cardiac Arrest Syndrome admitted to the ICU.
Detailed description
Patients presenting Post-Cardiac Arrest Syndrome (PCAS) in the 24 hours following their admission in Intensive Care Unit will be randomly assigned either to a control group (standard of care) either to a "Hemoadsorption" group. In the latter, the patient will be connected in the 6 hours following randomization to an extracorporeal circuit, in which a Cytosorb ® cartridge will be placed. The circuit will be set up in hemoperfusion mode. The therapy will take place for a minimum of 12 hours and a maximum of 24 hours. Anticoagulation will be achieved using a regional heparin-protamin regimen.
Blood samples will be collected at randomization, T1 (6 hours post-randomization), T2 (12 hours after randomization), T3 (24 hours after randomization), T4 (48 hours after randomization) and T5 (48 hours after randomization), to assess change in inflammatory cytokine levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hemoadsorption | Experimental | Device: CytoSorb® HemoadsorptionHemoadsorption is performed using a CytoSorb® cartridge. |
| Control | No intervention | –Post-cardiac arrest management will be conducted as per institutional protocols. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (13 listed)
- Evidence for patient's refusal to participate in clinical trials
- Non commitment for ongoing medical therapy (imminent withdrawal of care)
- Cardiac arrest caused by hemorrhagic shock
- Contraindications to therapeutic heparinization
- Shock of primary cardiac origin (LVEF <20%)
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® HemoadsorptionThe therapy is initiated within 6 hours from randomization and maintained for a minimum of 12 consecutive hours to a maximum of 24 consecutive hours. | Device | Hemoadsorption |
Primary outcome
Change in cytokine levels
Time frame: From baseline (randomization) to 72 hours after randomization
Plasma levels reduction of the following inflammatory mediators: IL-1β,IL-1Ra, IL-6, IL-8, IL-10 and TNF-α.
Incidence of Treatment-Emergent Adverse Events
Time frame: From beginning of hemoadsorption to 24 hours after the end of hemoadsorption, incidence of adverse events such as haemorrhagic complications, catheter-insertion related complications and anaphylactoid reactions
Rate of intervention-related complications
5 secondary outcomes
Vasopressor requirements
Time frame: From baseline (randomization) to 72 hours after randomization
In-hospital mortality
Time frame: Day 14, 28 and 90 after randomization
Shock reversal
Time frame: Within 24 hours from randomization
Sequential Organ Failure Assessment Score (SOFA)
Time frame: Day 1 to 7 after randomization
CRP and Procalcitonin Levels
Time frame: Day 1, 2, 3 after randomization
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 14 Mar 2022.
- Derived from this study: PubMed 36691082Monard C, Bianchi N, Poli E, Altarelli M, Debonneville A, Oddo M, Liaudet L, Schneider A. Cytokine hemoadsorption with CytoSorb(R) in post-cardiac arrest syndrome, a pilot randomized controlled trial. Crit Care. 2023 Jan 23;27(1):36. doi: 10.1186/s13054-023-04323-x.
- 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.
Antoine Schneider, MD, PhD principal investigator
Centre Hospitalier Universitaire Vaudois
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® Hemoadsorption in people with Cardiac Arrest, run by Centre Hospitalier Universitaire Vaudois at 1 site in Switzerland.
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 0 inclusion and 13 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 14 Mar 2022. 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 Switzerland. 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?
Change in cytokine levels (time frame: From baseline (randomization) to 72 hours after randomization). The study lists 2 primary outcomes in all. 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 NCT03523039, 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 14 Mar 2022.