The effects of extracorporeal blood purification (oXiris®) in patients with cardiogenic shock requiring VA-ECMO: A prospective, open-label, randomized controlled pilot study
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Symptoms, signs and abnormal clinical and laboratory findings, NEC
- Sponsor
- Samsung Medical Center
- Enrollment
- 40
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
Eligibility 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
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
- •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
Outcomes
Primary Outcomes
Not specified