Early Left Atrial Septostomy Versus Conventional Approach After Venoarterial Extracorporeal Membrane Oxygenation: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Cumulative incidence rate of all-cause death
研究概览
简要总结
The use of venoarterial-extracorporeal membrane oxygenation(VA-ECMO) was associated with lower in-hospital mortality in patients with cardiogenic shock. However, VA-ECMO has a deleterious effect for hemodynamics. It can increase left ventricular end-diastolic pressure(LVEDP), followed by left ventricular dilatation, abnormal opening of aortic valve and jeopardizes of myocardial recovery. Therefore, several methods have been used to reduce LVEDP. Among these, left atrial septostomy is effective, but less invasive than surgical left ventricular unloading. However, there is few data regarding this issue. Therefore, the investigators will evaluate the effect of routine, early left atrial septostomy in patients with VA-ECMO for the treatment of cardiogenic shock.
详细描述
Study Objectives:
To determine the effect of early left atrial septostomy versus conventional approach(left atrial septostomy only in cases of significant changes due to left ventricular end-diastolic pressure increase) in patients who received venoarterial-extracorporeal membrane oxygenation(VA-ECMO) for the treatment of cardiogenic shock.
Study Background:
Cardiogenic shock is due to myocardial dysfunction from multifactorial causes, which has high mortality. The treatment for cardiogenic shock includes early coronary revascularization, inotropes, vasopressors, or mechanical circulatory support, such as intraaortic balloon pump(IABP), VA-ECMO. However, the routine use of IABP is not recommended for the treatment of cardiogenic shock in recent guidelines. VA-ECMO can be easily implanted, and can maintain high cardiac output. In several studies, The use of VA-ECMO was associated with lower in-hospital mortality in patients with cardiogenic shock.
However, VA-ECMO has a deleterious effect for hemodynamics. It can increase left ventricular end-diastolic pressure(LVEDP), followed by left ventricular dilatation, abnormal opening of aortic valve and jeopardizes of myocardial recovery. Therefore, several methods have been used to reduce LVEDP. Among these, left atrial septostomy is effective, but less invasive than surgical left ventricular unloading. However, there is few data regarding this issue. Therefore, the investigators will evaluate the effect of routine, early left atrial septostomy in patients with VA-ECMO for the treatment of cardiogenic shock.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age more than 18 years old 2) Cardiogenic shock* 3) Successful VA-ECMO implantation
- •The definition of cardiogenic shock All these criteria should be met
- •Systolic blood pressure < 90 mmHg for 30 minutes, or needing inotrope or vasopressor to maintain systolic blood pressure > or = 90 mmHg
- •Pulmonary congestion on chest X-ray or increased left ventricular filling pressure by cardiac catheterization
- •At least one criteria of organ dysfunction
- •mental obtundation, clammy skin, oliguria, renal dysfunction, increased level of blood lactate
排除标准
- •VA-ECMO after open heart surgery
- •VA-ECMO for the treatment of non-cardiac shock
- •Severe bleeding*
- •Terminal malignancy
- •Irreversible brain damage
- •Pregnancy or lactation
- •The definition of severe bleeding Hemoglobin decrease after VA-ECMO or cannulation site bleeding is not a exclusion criteria
- •Hypovolemic shock due to definite bleeding cause
- •Identifiable bleeding causes: gastrointestinal bleeding, hemothorax, traumatic bleeding, central nervous system hemorrhage, pulmonary hemorrhage
结局指标
主要结局
Cumulative incidence rate of all-cause death
时间窗: Up to 30 days
Cumulative incidence rate of all-cause death
次要结局
- Cumulative incidence rate of non-cardiac death(Up to 12 months)
- Weaning rate from mechanical ventilator during index admission(Up to 6 months)
- Lactate clearance rate(Up to 30 days)
- Rate of transient ischemic attack or stroke during index admission(Up to 6 months)
- Rate of BARC bleeding type 3 or 5 during index admission(Up to 6 months)
- Cumulative incidence rate of cardiac death(Up to 12 months)
- Rate of all-cause death or left atrial septostomy in conventional approach group(Up to 30 days)
- Rate of left atrial septostomy in conventional approach group(Up to 30 days)
- Incidence rate of all-cause death during index admission(Up to 6 months)
- Hospital length of stay(Up to 6 months)
- Lactate normalization rate(Up to 30 days)
- Rate of renal replacement therapy during index admission(Up to 6 months)
- Rate of bridge to ventricular assist device or heart transplantation during index admission(Up to 6 months)
- Cumulative incidence rate of all-cause death(Up to 12 months)
- Re-hospitalization rate due to heart failure(Up to 12 months)
- All-cause death or re-hospitalization rate due to heart failure(Up to 12 months)
- Rate of major vascular injury or cardiac tamponade during left atrial septostomy(Up to 30 days)
- Weaning rate from venoarterial extracorporeal membrane oxygenation during index admission(Up to 6 months)
- Rate of disappearance of pulmonary edema on chest X-ray during index admission(Up to 6 months)
- Intensive care unit length of stay during index admission(Up to 6 months)
- Rate of limb ischemia during index admission(Up to 6 months)
- Rate of infection during index admission(Up to 6 months)
研究者
Min Chul Kim
Associate Professor
Chonnam National University Hospital