Cardiogenic ShockCLEAN ECMONCT05642273
The Effects of oXiris in Cardiogenic Shock Requiring VA-ECMO
A study testing oXiris membrane and Blood tests in people with Cardiogenic Shock, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
Cardiogenic shock (CS) defines a state of systemic hypo-perfusion leading to end-organ dysfunction related to cardiac pump failure and with mortality rates in the range of 27-50% according to recent reviews. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiogenic Shock
- What is being tested?
- oXiris membrane and Blood tests
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- 25 Nov 2022to 8 Jan 2024
- 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
- Patients with more than 18 years old
- CS is defined as the presence of the following:
- 2-1) Systolic blood pressure is less than 90 mmHg for more than 30 minutes despite the fluid therapy, or the use of pressure boosting agents to maintain the systolic blood pressure more than 90 mmHg.
- 2-2) Peripheral hypoperfusion (cold skin, urine less than 30 cc per hour, impaired consciousness, lactate ≥2.0 mmol/l) or a person with pulmonary edema.
- 2-3) Causes of CS include ischemic (acute myocardial infarction or ischemic cardiomyopathy, shock during percutaneous coronary intervention), myocardial (end-stage heart failure, myocarditis), post-cardiotomy shock, cardiac tamponade, or pulmonary thromboembolism.
- Patients receiving VA ECMO owing related to the causes listed in 2-1, 2-2, 2-3.
- Written informed consent from patient or legal surrogates
Who cannot join
- Other causes except for CS: septic shock, cardiac arrest by serious ventricular arrhythmia mot related to the myocardial ischemia or heart failure.
- Shock with unwitnessed cardiac arrest outside the hospital
- Severe non-cardiac morbidity with expected survival less than 6 months (malignancy, respiratory failure)
- Suspicious of brain death
- Those who refused active treatment
- Body weight under 30 kg
- Heparin allergy
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of extraCorporeal bLood Purification (oXiris ®) in patiEnts With cArdiogeNic Shock Requiring VA-ECMO: A Prospective, Open-label, Randomized Controlled Pilot Study
Cardiogenic shock (CS) defines a state of systemic hypo-perfusion leading to end-organ dysfunction related to cardiac pump failure and with mortality rates in the range of 27-50% according to recent reviews. Patients with CS often received mechanical circulatory support, and venoarterial extracorporeal membrane oxygenator (V-A ECMO) is an effective tool to support refractory CS while ensuring continuous organ perfusion. Patients with CS present clinical signs of systemic inflammation and elevated plasma levels of prototypical inflammatory and vasoactive mediators, including C-reactive protein (CRP), Interleukin-6 (IL-6) and tumor necrosis factor alpha (TNFα). As data is scarce in this field, we decided to perform a prospective randomized controlled pilot study to investigate the efficacy of extracorporeal cytokine and lipopolysaccharide adsorption using Oxiris on humoral inflammation parameters, hemodynamics, and clinical outcomes in patients with CS requiring VA ECMO.
- Conditions
- Cardiogenic Shock
- Being tested
- oXiris membrane, Blood tests
- Keywords
- cardiogenic shock, venoarterial extracorporeal membrane oxygenation, endotoxin, cytokine, oXiris
- Medical subject headings
- Shock, Cardiogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oXiris membraneDevice
oXiris membrane for 24h
Blood testsDiagnostic test
Blood tests just after randomization (0 h) and at 24 h, 48 h and 7 days
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Oxiris for 24 h Receives: Device: oXiris membrane; Diagnostic Test: Blood tests |
| Control | Active comparator | Usual care Receives: Diagnostic Test: Blood tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endotoxin level at 48 h
Plasma endotoxin level
Measured: 48 hours after enrollment
Secondary outcomes (6)
Vasoactive-Inotrope score
VIS = dopamine (µg/kg/min) + dobutamine (µg/kg/min) + 100 × epinephrine (µg/kg/min) + 100 × norepinephrine (µg/kg/min) + 10 × milrinone (µg/kg/min) + 10,000 × vasopressin (units/kg/min) + 50 × levosimendan (µg/kg/min)
Measured: baseline, 24 hours, 48 hours, 72 hours, 96 hours, Day 7
Sequential Organ Failure Assessment score
determine rate of organ failure (higher scores mean a worse outcome)
Measured: baseline, 24 hours, 48 hours, 72 hours, 96 hours, Day 7
Plasma cytokines
IL-6, IL-4, IL-10, TNF-α, IL-1β/IL-1F2, CCL2/JE/MCP-1, IFN-gamma, IL-8/CXCL8
Measured: baseline, 24 hours, 48 hours, Day 7
GDF-15, angiopoietin-2
endothelial dysfunction
Measured: baseline, 24 hours, 48 hours, Day 7
Hospital mortality
death
Measured: at hospital discharge, through study completion, an average 2 months
Neurologic outcome
Cerebral Performance Catergories scale
Measured: at hospital discharge, through study completion, an average 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2022
- Study start25 Nov 2022
- Primary completion8 Jan 2024
- Study completion8 Jan 2024
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 Cardiogenic ShockStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeong Hoon Yang, Samsung Medical Center
- Investigators
- Jeong Hoon Yang, MD, PhD, Principal investigator, Department of Critical Care Medicine, Samsung Medical Center, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05642273
- Sponsor's protocol ID
- CLEAN ECMO
- Acronym
- CLEAN ECMO
- Status last verified
- Mar 2024
- First submitted
- 28 Nov 2022
- Last updated
- 29 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ko RE, Choi KH, Lee K, Jeon J, Jang HR, Chung CR, Cho YH, Park TK, Lee JM, Song YB, Hahn JY, Choi SH, Gwon HC, Yang JH. The effects of extracorporeal blood purification (oXiris(R)) in patients with cardiogenic shock who require VA-ECMO (CLEAN ECMO): a prospective, open-label, randomized controlled pilot study. Crit Care. 2025 Jun 20;29(1):255. doi: 10.1186/s13054-025-05495-4.
PubMed 40542431
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of extraCorporeal bLood Purification (oXiris ®) in patiEnts With cArdiogeNic Shock Requiring VA-ECMO: A Prospective, Open-label, Randomized Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT05642273
- Acronym / sponsor ID
- CLEAN ECMO / CLEAN ECMO
- Conditions
- Cardiogenic Shock
- Keywords
- cardiogenic shock, venoarterial extracorporeal membrane oxygenation, endotoxin, cytokine, oXiris
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 25 Nov 2022 (actual)
- Primary completion
- 8 Jan 2024 (actual)
- Study completion
- 8 Jan 2024 (actual)
- First posted
- 8 Dec 2022 (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.
Cardiogenic shock (CS) defines a state of systemic hypo-perfusion leading to end-organ dysfunction related to cardiac pump failure and with mortality rates in the range of 27-50% according to recent reviews. Patients with CS often received mechanical circulatory support, and venoarterial extracorporeal membrane oxygenator (V-A ECMO) is an effective tool to support refractory CS while ensuring continuous organ perfusion. Patients with CS present clinical signs of systemic inflammation and elevated plasma levels of prototypical inflammatory and vasoactive mediators, including C-reactive protein (CRP), Interleukin-6 (IL-6) and tumor necrosis factor alpha (TNFα). As data is scarce in this field, we decided to perform a prospective randomized controlled pilot study to investigate the efficacy of extracorporeal cytokine and lipopolysaccharide adsorption using Oxiris on humoral inflammation parameters, hemodynamics, and clinical outcomes in patients with CS requiring VA ECMO.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: oXiris membrane, Diagnostic Test: Blood testsOxiris for 24 h |
| Control | Active comparator | Diagnostic Test: Blood testsUsual care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients with more than 18 years old
- CS is defined as the presence of the following:
- 2-1) Systolic blood pressure is less than 90 mmHg for more than 30 minutes despite the fluid therapy, or the use of pressure boosting agents to maintain the systolic blood pressure more than 90 mmHg.
- 2-2) Peripheral hypoperfusion (cold skin, urine less than 30 cc per hour, impaired consciousness, lactate ≥2.0 mmol/l) or a person with pulmonary edema.
- 2-3) Causes of CS include ischemic (acute myocardial infarction or ischemic cardiomyopathy, shock during percutaneous coronary intervention), myocardial (end-stage heart failure, myocarditis), post-cardiotomy shock, cardiac tamponade, or pulmonary thromboembolism.
Key exclusion criteria (8 listed)
- Other causes except for CS: septic shock, cardiac arrest by serious ventricular arrhythmia mot related to the myocardial ischemia or heart failure.
- Shock with unwitnessed cardiac arrest outside the hospital
- Severe non-cardiac morbidity with expected survival less than 6 months (malignancy, respiratory failure)
- Suspicious of brain death
- Those who refused active treatment
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 |
|---|---|---|
| oXiris membraneoXiris membrane for 24h | Device | Intervention |
| Blood testsBlood tests just after randomization (0 h) and at 24 h, 48 h and 7 days | Diagnostic test | Control, Intervention |
Primary outcome
Endotoxin level at 48 h
Time frame: 48 hours after enrollment
Plasma endotoxin level
6 secondary outcomes
Vasoactive-Inotrope score
Time frame: baseline, 24 hours, 48 hours, 72 hours, 96 hours, Day 7
Sequential Organ Failure Assessment score
Time frame: baseline, 24 hours, 48 hours, 72 hours, 96 hours, Day 7
Plasma cytokines
Time frame: baseline, 24 hours, 48 hours, Day 7
GDF-15, angiopoietin-2
Time frame: baseline, 24 hours, 48 hours, Day 7
Hospital mortality
Time frame: at hospital discharge, through study completion, an average 2 months
Neurologic outcome
Time frame: at hospital discharge, through study completion, an average 2 months
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 29 Mar 2024.
- Derived from this study: PubMed 40542431Ko RE, Choi KH, Lee K, Jeon J, Jang HR, Chung CR, Cho YH, Park TK, Lee JM, Song YB, Hahn JY, Choi SH, Gwon HC, Yang JH. The effects of extracorporeal blood purification (oXiris(R)) in patients with cardiogenic shock who require VA-ECMO (CLEAN ECMO): a prospective, open-label, randomized controlled pilot study. Crit Care. 2025 Jun 20;29(1):255. doi: 10.1186/s13054-025-05495-4.
- 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.
Jeong Hoon Yang, MD, PhD principal investigator
Department of Critical Care Medicine, Samsung Medical Center, Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oXiris membrane and Blood tests in people with Cardiogenic Shock, run by Samsung Medical Center at 1 site in South Korea.
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 7 inclusion and 8 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 29 Mar 2024. 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 South Korea. 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?
Endotoxin level at 48 h (time frame: 48 hours after enrollment). 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 NCT05642273, 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 29 Mar 2024.