Reduction of Inflammation Reaction to Extracorporeal Circulation in Cardiac Surgery by Interleukin Dialysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change of levels of cytokines during procedure compared to baseline
研究概览
简要总结
The aim of this study is to prove that using a CytoSorb(TM) filter in the cardiopulmonary circuit attenuates the inflammatory response to extracorporeal circulation in patients undergoing cardiac surgery. The hypothesis is that removing cytokines from patients' blood by the CytoSorb device significantly improves circulation and outcome in patients undergoing on-pump cardiac surgery.
详细描述
Cardiac surgery with cardiopulmonary bypass (CPB) induces an inflammatory response due to contact of patients' blood with foreign surfaces like tubes or the oxygenator, ischemic-reperfusion injury and surgical trauma. Inflammation is modulated by cytokines, especially, interleukins. The extent of cytokine release is further related to the duration of bypass and the amount of operating field suction. This results in a systemic inflammatory response syndrome (SIRS) with the risk of multiple organ dysfunction (MOD). Also in patients treated with extracorporeal membrane oxygenation (ECMO) an activation of the inflammation system is seen and accompanied with an increase of cytokine levels. The cytokine concentration correlates with the severity of the immune reaction and can be a predictor of the outcome of the patient. As severe SIRS and MOD significantly increase mortality, the attenuation of the inflammatory response is supposed to reduce morbidity and mortality after cardiac surgery.
For adult cardiac surgery and patients who are treated with an extracorporal assist device, a tool for cytokine elimination and attenuation of the inflammatory response seems to be beneficial.
In our study we are going to investigate if the use of the CytoSorb device can improve the outcome of patients undergoing elective coronar artery bypass and heart valve surgery.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •undergoing elective coronar bypass AND heart valve surgery
- •expected duration of bypass more than 120 min
排除标准
- •age under 18 years of age
- •pregnancy
- •medication that interacts with the immune system (e.g. steroids, immune suppressors)
- •patients with diagnosed immunodeficiency (e.g. HIV/AIDS)
- •heparin induced thrombocytopenia type II
- •patients that decline participation
研究组 & 干预措施
Withouot device
Patients randomised to this arm are treated without the CytoSorb device during bypass.
With CytoSorb device
Patients randomised to this arm are treated with the CytoSorb device during bypass.
干预措施: CytoSorb device (Device)
结局指标
主要结局
Change of levels of cytokines during procedure compared to baseline
时间窗: 1) 5 minutes before bypass 2) 2 hours after begin of bypass, 3) at the end of bypass, approximately 3 hours after begin of bypass, 4) 6 hours after bypass 5) 24 hours after bypass
parameters to be measured are: interleukin (IL) 1, interleukin 6, interleukin 8, interleukin 10, tumor necrosis factor-alpha
次要结局
- Change of hemodynamic parameters during procedure compared to baseline(1) 5 kinutes before bypass 2) 2 hours after begin of bypass, 3) at the end of bypass, approximately 3 hours after begin of bypass, 4) 6 hours after bypass 5) 24 hours after bypass)
- Thromboelastometry(at the end of bypass, approximately 3 hours after begin of surgery)
- Change of cognitive and emotional state in comparison to condition before surgery(1)one day before surgery 2) 24 hours after bypass)