A Prospective observational study to evaluate the outcome of cytokine hemadsorption during aortic surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- 1. Intra and post operative hemodynamic stability as evidenced by relative difference of the vasopressor requirement.
研究概览
简要总结
The Hypothesis of this study is that Cytokine removal using Cytosorb therapy during cardiopulmonary bypass (CPB) significantly reduces Hyperinflammation and improves Hemodynamic stability in patients undergoing Aortic Surgery.
This study will enable to assess the impact of the treatment with Cytosorb 300 ml device on the course of hyperinflammation, hemodynamic stability and multi-organ failure in patients undergoing CPB assisted surgery for aortic diseases.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •All patients above 18 years of age giving consent eligible for Elective aortic surgery under Cardiopulmonary Bypass.
排除标准
- •Patients below 18 years of age Patient did not provide consent Emergency surgery patients Patients undergoing aortic dissection Infective Endocarditis Moribund patients expected to die <24 hours Patients receiving chemotherapy, immunosuppressants and steroids.
结局指标
主要结局
1. Intra and post operative hemodynamic stability as evidenced by relative difference of the vasopressor requirement.
时间窗: T1(Baseline) | T2(2hours after Discontinuation of CPB) | T3(24 hours after Discontinuation of CPB) | T4(48 hours after Discontinuation of CPB) | T5(15 days after Surgery)
2.Assessment of device related adverse events during study period.
时间窗: T1(Baseline) | T2(2hours after Discontinuation of CPB) | T3(24 hours after Discontinuation of CPB) | T4(48 hours after Discontinuation of CPB) | T5(15 days after Surgery)
次要结局
- Evaluation of IL-6,CRP,Procalcitonin,lactate levels.(2. Need and duration of renal replacement therapy.)