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临床试验/NCT03978728
NCT03978728已完成不适用

Analysis of Endotoxin Activity in Patients With Extracorporeal Membrane Oxygenation Life Support System

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2019年8月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
55
试验地点
1
主要终点
Endotoxin activity level

研究概览

简要总结

Extra-corporeal membrane oxygenation (ECMO) can temporarily help patients gain time to wait for cardiopulmonary recovery or further treatment in patients with cardiopulmonary failure. Whether the blood flow provided by the ECMO can maintain the perfusion of various organs is an important factor affecting survival. Some ECMO patients died after the complication of sepsis. Our previous pilot analysis has recognized several ECMO patients with complicated sepsis has high endotoxin activity level. Endotoxemia can also occur in heart surgery and after cardiopulmonary bypass, trauma, organ transplantation, and out-of-hospital cardiac arrest patients. These trials used endotoxin activity analysis (EAA, EAATM, Spectral Diagnostics Inc., Canada) to analyze endotoxin activity. In addition, studies have indicated that the combination of procalcitonin (PCT) concentration and EAA activity can improve the accuracy of predicting sepsis. The primary aim of this study is to detect endotoxin activity in patients with ECMO support and compare whether the prognosis was associated with different level of EAA activity. The secondary aims are to analyze the risk factors leading to high EAA activity and investigate the diagnostic value of septic shock combining PCT examination. We suggest that the results of this study may help the ECMO medical team identify patients at high risk for septic shock and conduct adequate managements to improve patient survival and quality of life after survival.

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
20 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients with ECMO support

排除标准

  • < 20 years old or > 90 years old
  • not be able to collect blood sample within 48 hours after placement of ECMO
  • change plan to palliative care and plan to remove ECMO
  • non-native speakers

结局指标

主要结局

Endotoxin activity level

时间窗: within 48 hours

Endotoxin activity level is measured by endotoxin activity analysis kit

次要结局

  • Diamine oxidase level(within 48 hours)
  • Cystatin C level(within 48 hours)
  • Endotoxin activity level(within 96 hours)
  • Procalcitonin level(within 48 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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