Removal of Cytokine on Cardiopulmonary Bypass With CytoSorb® Compared to on- and Off-pump Myocardial Revascularization
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Evolution of the inflammatory response
研究概览
简要总结
Cardiac surgery leeds to a systematic inflammatory response induced by the surgical trauma and the use of the cardiopulmonary bypass (CPB). Activation of inflammatory cascades can cause a systemic inflammatory response syndrome (SIRS) which is associated with increased morbidity and mortality. Therefore, strategies to reduce the inflammatory response have a potential benefit for cardiac surgery patients.
The clinical benefit of reducing proinflammatory cytokines such as IL-6, Il-8 and TNF-a with the use of a cytokine adsorbing circuit (Cytosorb) during CBP remains unclear. Therefore, the investigators conduct this prospective, observational pilot study to determine the clinical impact of the use of a cytokine adsorbing circuit during CBP.
详细描述
Patients, who have an elective myocardial revascularization and give there written consent will be enrolled to the study. Demographic, intraoperative, and postoperative data will be collected prospectively. Furthermore, blood samples (1. before induction of anaesthesia 2. at the end of CPB 3. 6 hours after surgery 4. 24 hours after surgery 5. 3-5 days after surgery) will be analyzed.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •• Elective myocardial revascularization
排除标准
- •Emergency procedures
- •Declined informed consent
- •Body mass index < 18
- •Age < 18 years
- •Pregnant women
- •Receiving chemotherapy
- •Diagnosed with any disease state (e.g., AIDS) that has produced leukopenia
- •Receiving antileukocyte drugs
- •Receiving TNF-α Blockers
- •Receiving immunosuppressive drugs or hormone therapy (e.g. tamoxifen)
- •CRP > 5 mg/dl
结局指标
主要结局
Evolution of the inflammatory response
时间窗: Change from Baseline in cytokine level direct after surgery, 6 and 24 hours after surgery; 5. postoperative day
Il-6; Il-8; TNF-a; C3/C4-complement Leucocytes CRP
次要结局
- kidney injury(participants will be followed for the duration of hospital stay, an expected average of 10 days)
- Length of catecholamine therapy(participants will be followed for the duration of hospital stay, an expected average of 10 days)
- Length of ICU and hospital stay(participants will be followed for the duration of hospital stay, an expected average of 10 days)
- Length of ventilation(participants will be followed for the duration of hospital stay, an expected average of 10 days)
- MACCE (mortality; myocardial infarction; cerebrovascular accident)(participants will be followed for the duration of hospital stay, an expected average of 10 days)
研究者
Dr. Antje-Christin Deppe
MD, Resident Cardiac Surgery
University Hospital of Cologne