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临床试验/NCT02119585
NCT02119585Unknown不适用

Observational Study to Analyze Respiratory System Mechanics Changes and Inflammatory Responses During Orthotopic Liver Transplantation (SPPLIT Trial)

University of Turin, Italy1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2014年2月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
30
试验地点
1
主要终点
Elastance of Respiratory System, Lung and Chest Wall

研究概览

简要总结

During orthotopic liver transplantation (OLT), respiratory system function may be severely impaired for several reasons including anaesthesia effects, hyperdynamic volume state with fluid overload and ischemia reperfusion injury. In particular, reperfusion syndrome is characterised by the release of several inflammatory mediators such as cytokines and oxygen free radicals which may contribute to alveolar endothelial barrier dysfunction. The object of this study is to investigate the respiratory system mechanics impairment in its partitioning between lung and chest wall.

We hypothesize that impairment of respiratory system mechanics (of both lung and chest wall) occurs after reperfusion phase of liver. This impairment is associated with the systemic inflammatory response following liver reperfusion.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • orthotopic liver transplantation
  • valid informed consent

排除标准

  • Age < 18 yrs

结局指标

主要结局

Elastance of Respiratory System, Lung and Chest Wall

时间窗: at 24 hours after liver reperfusion

次要结局

  • Inflammatory mediators in plasma samples(baseline, 90 minutes, 3 hours and 24 hours after reperfusion phase)
  • Inflammatory mediators in urine samples(baseline, 90 minutes, 3 hours and 24 hours after reperfusion phase)
  • Acute respiratory failure(28 days)
  • hospital length of stay(28 days)
  • Ventilator free days(28 days)
  • ICU length of stay(28 days)

研究者

发起方
University of Turin, Italy
申办方类型
Other
责任方
Principal Investigator
主要研究者

Vito Fanelli MD, PhD

Assistant professor

University of Turin, Italy

研究点 (1)

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