The Effects of oXiris in Cardiogenic Shock Requiring VA-ECMO ( CLEAN ECMO )
- Conditions
- Symptoms, signs and abnormal clinical and laboratory findings, NEC
- Registration Number
- KCT0008312
- Lead Sponsor
- Samsung Medical Center
- Brief Summary
In this prospective, randomized pilot study of patients with CS requiring V-A ECMO, we investigated the efficacy of extracorporeal endotoxin and cytokine adsorption using oXiris. Our key findings can be summarized as follows: 1) the primary outcome of endotoxin levels at 48 hours did not significantly differ between the oXiris and control groups; 2) time-dependent analysis revealed significant reductions in inflammatory markers, particularly GDF-15 and IL-6, in the oXiris group at 24, 48 hours, and 7 days post-intervention; 3) hemodynamic parameters showed improvement in the oXiris group, with significant decreases in VIS and lactate levels, especially at 24 and 48 hours post-intervention; 4) ECMO weaning success, duration of ECMO support, and mortality rates were not significantly different between the groups.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 40
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.
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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in the value of endotoxin
- Secondary Outcome Measures
Name Time Method 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.