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临床试验/NCT02393274
NCT02393274已完成不适用

Investigation of Microcirculation in Patients With Venoarterial Extracorporeal Membrane Oxygenation Life Support

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2015年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
48
试验地点
1
主要终点
Perfused small vessel density

研究概览

简要总结

Extra-corporeal membrane oxygenation (ECMO) life support system can provide both cardiac and respiratory support to patients with heart and respiratory failure. It can save time for these organs to recovery or for these patients to receive further management. However, many patients will die in spite of ECMO support. One of the key factor is whether the blood flow provided by the ECMO can meet the requirement of organ perfusion. The adequacy of macrocirculation may be determined by arterial pressure and minute blood flow of ECMO. However, the adequacy of microcirculation remains as a major unresolved clinical problem. This is a prospective observational clinical trial. The sublingual microcirculation will be examined with the incident dark field video microscope within 6 hours after venoarterial ECMO placement, and then at 24 h, 48 h, 72 h, and 96 h. The severity of multiple organ injury and clinical data will be recorded as well. The major parameters of microcirculation include total small vessel density, perfused small vessel density, and microvascular flow index. The sublingual microcirculation will also be examined before weaning off ECMO, within 6 hours after ECMO removal, and then at 24 h, 48 h, and 72 h. Serum level of endothelial cell specific molecule-1 at specific time points will be examined. The data of 14-day mortality, 28-day mortality, duration of ECMO support, and intensive care unit stay will be recorded. This study aims primarily to investigate the relationship between microcirculation and prognosis of these patients. This study will also investigate the relationship among serum level of endothelial cell specific molecule-1, microcirculation, and prognosis of these patients. Wish the results of this study can be applied in further research to help to improve the quality of ECMO care.

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 79 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who require venoarterial extra-corporeal membrane oxygenation (ECMO) life support

排除标准

  • who can not take an examination of sublingual microcirculation within 6 hours after placement of venoarterial ECMO support
  • Non-native speakers

结局指标

主要结局

Perfused small vessel density

时间窗: At enrollment (within 12 hour after placement of extra-corporeal membrane oxygenation life support)

Perfused small vessel density measured by incident dark field video microscope

次要结局

  • Endocan level(At enrollment)
  • Total small vessel density(At Enrollment)
  • Microvascular flow index(At enrollment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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