Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Oxiris for 24 h |
|
| Control | Active Comparator | Usual care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oXiris membrane | Device | oXiris membrane for 24h |
| |
| Blood tests |
| Measure | Description | Time Frame |
|---|---|---|
| Endotoxin level at 48 h | Plasma endotoxin level | 48 hours after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | baseline, 24 hours, 48 hours, 72 hours, 96 hours, Day 7 |
| Sequential Organ Failure Assessment score |
Not provided
Inclusion Criteria:
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
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jeong Hoon Yang, MD, PhD | Department of Critical Care Medicine, Samsung Medical Center, Korea | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Seoul | 06351 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40542431 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D012770 | Shock, Cardiogenic |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D006403 | Hematologic Tests |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Diagnostic Test |
Blood tests just after randomization (0 h) and at 24 h, 48 h and 7 days |
|
determine rate of organ failure (higher scores mean a worse outcome) |
| 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 | baseline, 24 hours, 48 hours, Day 7 |
| GDF-15, angiopoietin-2 | endothelial dysfunction | baseline, 24 hours, 48 hours, Day 7 |
| Hospital mortality | death | at hospital discharge, through study completion, an average 2 months |
| Neurologic outcome | Cerebral Performance Catergories scale | at hospital discharge, through study completion, an average 2 months |
| D014652 |
| Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D012769 | Shock |