None listed
Conditions
Interventions
Medical Device : 1. Experimental: Intervention, Oxiris for 24 h
Device: oXiris membrane
oXiris membrane for 24h
Diagnostic Test: Blood tests
Blood tests just after randomization (H0) and at H24,H48 an
Sponsors
Samsung Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with more than 18 years old 2. 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), postcardiotomy shock, cardiac tamponade, or pulmonary thromboembolism. 3. Patients receiving VA ECMO owing related to the causes listed in 2-1, 2-2, 2-3.
Exclusion criteria
Exclusion criteria: 1. The patient or representative does not agree to the study 2. Pregnant women 3. Body weight under 30 kg 4. Heparin allergy 5. Other causes except for CS: septic shock, cardiac arrest by serious ventricular arrhythmia mot related to the myocardial ischemia or heart failure. 6. Shock with unwitnessed cardiac arrest outside the hospital 7. Severe non-cardiac morbidity with expected survival less than 6 months (malignancy, respiratory failure) 8. Suspicious of brain death 9. Those who refused active treatment 10. Out-of-hospital cardiac arrest with no witnesses
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the value of endotoxin | — |
Secondary
| Measure | Time frame |
|---|---|
| Vasoactive-Inotropic score(VIS);Sequential Organ Failure Assessment (SOFA);VA-ECMO weaning successful;ICU period date;inhospital mortality;evaluation of neurological prognosis according to Cerebral performance categories scale;Plasma cytokines change;Lactate clearance ;Improvement of endothermic cell dysfunction: A comparative analysis of iPSC-ECs' ability to form blood vessels and the degree of active oxygen production by adding serum of patients before and after oXiris® application to iPSC-ECs culture. | — |
Countries
Korea, Republic of
Contacts
Public ContactJeongHoon yang
Samsung Medical Center
Outcome results
None listed