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临床试验/NCT01879176
NCT01879176已完成3 期

Effect of Cytokine Removal in Cardiopulmonary Bypass Patients Using the Cytosorb ™ Filter

Medical University of Vienna2 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2013年8月最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
入组人数
46
试验地点
2
主要终点
IL-6

研究概览

简要总结

Cardiopulmonary bypass (CPB) surgery initiates a systemic inflammatory response induced by extrinsic (e.g. anesthesia, contact activation within the extracorporeal circuit, endotoxemia) and intrinsic (e.g. tissue damage, endothelial cell activation, ischemia-reperfusion injury of myocardium) factors. Monocytes are important players in systemic inflammation and the main producers of pro- and antiinflammatory cytokines. Monocytes activated by the extracorporeal circuit lead to a dysregulation of inflammatory homeostasis, increased levels of proinflammatory plasma mediators such as TNF-a, IL-1β, IL-6 and IL-18 are joined by antiinflammatory cytokines such as IL-10. This strong inflammatory response induces post surgical monocyte immunosuppression which is indicated by an impaired production of ex vivo LPS induced TNF-a production. Also malfunction of the peripheral circulation with increased lactate levels, pronounced fluid accumulation, increased need of vasopressors and cerebral dysfunction are observed. All of these factors may delay weaning from the ventilator, recovery of organ functions and discharge from ICU. Thus measures to decrease the inflammatory process have the potential to improve the perioperative course.

Use of cytokine adsorbing circuit during CBP has an effect on circulation cytokine levels for the first 36 hours after surgery and induces a decreased inflammatory response for up to 3 days post surgery.

详细描述

Patients, who have an elective cardiac surgical intervention with an expected CBP duration >120 minutes (e.g.: valve surgery, coronary artery bypass graft (CABG), combined procedures) will be enrolled to the study after given informed consent.

Patients, who decline will be asked to collect their secondary outcome data to create a "real - life" group and increase the number of patients in the control group. In this "real - life" group no additional blood samples will be taken.

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
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • elective cardiac surgical intervention with an expected CBP duration >120 minutes

排除标准

  • Emergency procedures
  • Heart transplantation
  • Elective left ventricular assist device (LVAD) implantation
  • Pulmonary thromendarterectomy
  • Declined informed consent
  • Serum creatinine > 2mg/dl
  • Body mass index < 18
  • Age < 18 years
  • Pregnant woman
  • Receiving chemotherapy or diagnosed with any disease state (e.g., AIDS) that has produced leukopenia
  • Receiving antileukocyte drugs
  • Receiving TNF-α Blockers, immunosuppressive drugs (e.g. tocilizumab)
  • CRP > 2mg/dl
  • History of Stroke
  • Bilirubin >2mg/dl

结局指标

主要结局

IL-6

时间窗: 1. Preoperative 2. Before CBP 3. After CPB 4. 2 hours after CPB 5. 24 hours 6. 48 hours 7. 120 hours

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Martin Bernardi

Doctor

Medical University of Vienna

研究点 (2)

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