Comparison Of Conservative Versus Early Distal Perfusion Strategy to Prevent Acute Limb Ischemia in Peripheral Venoarterial Extracorporeal Membrane Oxygenation Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Limb ischemia
研究概览
简要总结
Peripheral VA-ECMO is widely used in refractory cardiogenic shock patients as a salvage therapy. In most cases, the femoral artery and vein are used for the vascular approach. Large cannulas are usually used for proper oxygenation, which may cause peripheral limb ischemia. Distal perfusion catheterization (DPC) at the ipsilateral arterial cannula site is recommended to prevent distal limb ischemia. However, there is no consensus on the proper timing of DPC and additional invasive procedures may cause complications during VA-ECMO support. In this analysis, the investigators compare the clinical outcomes of distal limb ischemia complications between the conventional DPC group (DPC at the time of limb ischemia sign) and the preemptive DPC group (DPC at the time of VA-ECMO application).
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 ≥19 years old
- •Refractory cardiogenic shock with peripheral VA-ECMO
- •Informed consent
排除标准
- •Unwilling or unable to obtain informed consent from the participant or substitute decision-maker
- •Patients who are currently pregnant, postpartum period within 30 days or are breast-feeding
- •VA-ECMO application for causes other than cardiogenic shock
- •Severe coagulopathy
- •Irreversible limb ischemia requiring interventional procedures or surgery at the time of VA-ECMO (previously diagnosed ASO(atherosclerosis obliterans) patients)
结局指标
主要结局
Limb ischemia
时间窗: From date of randomization until the date of discharge or assessed up to 90 days
Limb ischemia requiring surgical/percutaneous procedure or resulting necrosis or neurologic sequelae in the distal limb during hospitalization
次要结局
- All-cause mortality(From date of randomization until the date of death from any cause, assessed up to 12 months)
- ECMO related complications(From date of randomization until the date of ECMO removal, assesed up to 90 days)
- Successful ECMO weaning(From date of randomization until the date of discharge or assessed up to 90 days)
研究者
Min-Seok Kim
Clinical Associate Professor
Asan Medical Center