Cytokine Filter Usage During Open Thoracoabdominal Aortic Aneurysm Repair- a Single-center Randomized Prospective Trial- Cytosorb and Its Imapct on Open TAAA Repair Outcome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Amount of perioperative catecholamine usage in mg/dl for the first seven days after surgery
研究概览
简要总结
Prospecrtive study including 20-30 randomized patients treated by open repair because of an TAAA larger than 55 mm During the surgery, a heart lung machine is applied for distal perfusion during aortic cross clamping to enable distal organ perfusion.
Regardless an intensive inflammatory reaction is a well known effect after reperfusion, leading to a uncontrolled inflammation during th first days after surgery. This may be associated to bad outcome and decreased survival rates. By the application of a intraoperative cytokine and DAMP filter this negative ffect could be reduced, resulting in a better outcome after surgery.
详细描述
Prospecrtive study including 20-30 randomized patients treated by open repair because of an TAAA larger than 55 mm During the surgery, a heart lung machine is applied for distal perfusion during aortic cross clamping to enable distal organ perfusion.
Regardless an intensive inflammatory reaction is a well known effect after reperfusion, leading to a uncontrolled inflammation during th first days after surgery. This may be associated to bad outcome and decreased survival rates. By the application of a intraoperative cytokine and DAMP filter this negative ffect could be reduced, resulting in a better outcome after surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Suffering from a TAAA larger than 55mm
排除标准
- •immunosupprive therapy pregnancy
结局指标
主要结局
Amount of perioperative catecholamine usage in mg/dl for the first seven days after surgery
时间窗: 7 days perioperatively -10 day postoperatively
amount measured in mg/dl
Amount of transfusion required during and after the surgery, assessed in transfusion more or less than 5 blood bags
时间窗: 7 days perioperatively 5-10 day postoperatively
packed cells, erythrocyte concentrate
次要结局
- Patients survival for the first 12 months after surgery(12 months 10-14 months postopertaibely)
- Acute kidney injury, measured using serum creatinine in mg/dl(7 days perioperatively, -10 day postoperatively)
研究者
Alexander Gombert
Principle Investigator PD Dr. med. Alexander Gombert, Specialist in Vascular Surgery
RWTH Aachen University