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临床试验/NCT02342236
NCT02342236已完成不适用

The Regional Cerebral Oxygen Saturation and Both S100B and GFAP Proteins Serum Concentration in Patients Undergoing Primary Hip Arthroplasty.

Military Institute od Medicine National Research Institute2 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2014年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
18
试验地点
2
主要终点
Changes in regional cerebral oxygen during primary hip arthroplasty

研究概览

简要总结

Postoperative Cognitive Disorders (POCD) are common in hospitalized people > 60 year old, especially in orthopedic patients. Etiology of POCD is complex, and in some aspects still remains unclear. The role of thromboembolic events in etiology of POCD was discussed. The incidence of such events in patients who underwent big joints arthroplasty can be as high as 40 to 60%, although some cases are subclinical. Thromboembolic material can block a blood flow through a vessels in the brain. As a consequence cerebral neurons can be damaged or destroyed. After neuronal damage specific substances, such as S100B protein, glial fibrillary acidic protein (GFAP) and neuron-specific enolase (NSE) are released to the blood. The serum concentrations of these biomarkers can be measured. Moreover, the block of blood flow will decrease regional cerebral saturation in affected parts of the brain.

In this project the authors would like to analyze the correlation between the regional cerebral saturation and serum concentration of both S100B protein and GFAP in orthopedic patients scheduled to primary hip arthroplasty.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
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

  • patient scheduled to primary hip arthroplasty,
  • orthopedic procedure under spinal anesthesia.

排除标准

  • patients younger than 18 y.o.,
  • surgery under general anesthesia,
  • patients who refused to participate in the study.

结局指标

主要结局

Changes in regional cerebral oxygen during primary hip arthroplasty

时间窗: Duration of the orthopedic procedure, an expected average of 2 hours.

The analysis of regional cerebral oxygen saturation will start just before the anesthesia and ends just after the surgery.

次要结局

  • Changes in serum levels of S100B protein from baseline at 72 hours after the surgery(72 hours)
  • Changes in serum levels of GFAP from baseline at 72 hours after the surgery(72 hours)

研究者

发起方
Military Institute od Medicine National Research Institute
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dariusz Tomaszewski

M.D., Ph.D.

Military Institute od Medicine National Research Institute

研究点 (2)

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