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临床试验/NCT03828032
NCT03828032Unknown不适用

Alternations of Multi-parameters Including Hemodynamic Concentration and Water Levels During Dehydration Therapy on Brain Edema Patients

Ting Li0 个研究点目标入组 80 人开始时间: 2019年9月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
80
主要终点
water concentration

研究概览

简要总结

This study aims to investigate the inner mechanism during different dehydration therapies such as mannitol injection and hypertonic saline. The investigators used a self-made near infrared spectroscopy (NIRS) instrument to monitor the physiological changes noninvasively including oxyhemoglobin ([HbO2]), deoxy-hemoglobin ([Hb]), the derived change in blood volume ([tHb]) and water concentration on the forehead of brain edema patients.

详细描述

Cerebral edema, as an acute head injury along with high intracranial pressure, has been of great interest over decades in clinical neurosurgery research. Dehydration therapy is a common clinical method to decrease intracranial pressure. This study aims to investigate the inner mechanism during different dehydration therapies such as mannitol injection and hypertonic saline. The investigators used a self-made near infrared spectroscopy (NIRS) instrument to monitor the physiological changes noninvasively including oxyhemoglobin ([HbO2]), deoxy-hemoglobin ([Hb]), the derived change in blood volume ([tHb]) and water concentration on the forehead of brain edema patients. Then the investigators compared the changes process of multiple physiological parameters during different dehydration therapies.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
20 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients who had brain edema and need dehydration therapy to decrease intracranial pressure.

排除标准

  • AIDS, Active Hepatitis, Tuberculosis, Syphilis
  • Patients who regularly take anticoagulants, antiplatelet drugs
  • Anemia, thrombocytopenia
  • Hemorrhagic disease like hemophilia

结局指标

主要结局

water concentration

时间窗: 2 weeks

water concentration of brain

Δ[HbO2]

时间窗: 2 weeks

changes of oxyhemoglobin concentration

次要结局

  • Δ[Hb](2 weeks)
  • intracranial pressure(2 weeks)

研究者

发起方
Ting Li
申办方类型
Unknown
责任方
Sponsor Investigator
主要研究者

Ting Li

Fellow

Chinese Academy of Medical Sciences

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