The effects of extracorporeal blood purification (oXiris®) in patients with cardiogenic shock requiring VA-ECMO: A prospective, open-label, randomized controlled pilot study
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 入组人数
- 40
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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
- •10. Out-of-hospital cardiac arrest with no witnesses