The Effect of Combination of Selective Antegrade Cerebral Perfusion With Retrograde Inferior Vena Caval Perfusion on the Outcomes in Patients Underwent Total Aortic Arch Replacement
试验速览
- 阶段
- 不适用
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Composite major complications
研究概览
简要总结
This study is designed as a multicenter, randomized, assessor- blinded clinical trial.The primary aim of this trial is to assess whether retrograde inferior venal caval perfusion combined selective antegrade cerebral perfusion(ACP)under mild hypothermia, compared with moderate hypothermia combined with selective ACP alone, improves the outcome for the patients undergoing total aortic arch replacement.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient aged 18 yr-65yr
- •Patient underwent total aortic arch replacement
排除标准
- •Inability to understand/give informed consent,
- •Participation in another clinical trial that interferes with the primary or secondary outcomes of this trial.
- •Inability to obtain superior and inferior vena caval cannulation due to pericardium adhesion
研究组 & 干预措施
RIVP group
After total cardiopulmonary bypass was initiated, the patient is cooled slowly to induce moderate hypothermia(28-30℃). The combination of selective antegrade cerebral perfusion and retrograde inferior vena caval perfusion is performed. The antegrade perfusion flow rate was is maintained at 6-12 mL/min/kg.Pump pressure of retrograde perfusion was is maintained at 20-30 mmHg, and blood flow was is maintained at 8-12 mL/min/kg.
干预措施: Retrograde Inferior Vena Caval Perfusion (Procedure)
ACP group
After total cardiopulmonary bypass was initiated, the patient is cooled slowly to induce moderate hypothermia(26-28℃). Only select antegrade cerebral perfusion is performed by maintaining the flow rate at 6-12 mL/min/kg.
干预措施: Select antegrade cerebral perfusion (Procedure)
结局指标
主要结局
Composite major complications
时间窗: up to 12 months
Newly Postoperative Renal Failure;Surgical Re-exploration；Operative Mortality;Deep Sternal Wound Infection;Stroke/Cerebrovascular Accident;Paraplegia
次要结局
- Respiratory Failure(up to 30 days)
- Transient Neurological Deficit(up to 30 days)
- Acute Kidney Injury not requiring Dialysis(up to 30 days)
- Myocardial Infarction(up to 30 days)
- Postoperative Prolonged Intubation(up to 30 days)
- Paraparesis(up to 30 days)