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临床试验/NCT06017635
NCT06017635尚未招募不适用

Non-invasive Monitoring and Serum Marker Study in Children With Cerebral Edema

Qilu Hospital of Shandong University0 个研究点目标入组 264 人开始时间: 2023年8月31日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
264
主要终点
Serum MMP-9 concentration

研究概览

简要总结

Purpose of the study:This study aimed to evaluate the clinical significance of serum SUR1, TRPM4 and MMP-9 in the diagnosis of cerebral edema in children with cerebral edema admitted to PICU by comparing them with CT results and perturbation coefficients, so as to provide biological indicators for clinical diagnosis of cerebral edema and provide targets for the treatment of cerebral edema in various diseases.

详细描述

Early and efficient use of various measures to control and monitor peripheral cerebral edema and intracranial pressure, timely and accurate adjustment of treatment plan to reduce the degree of cerebral edema and reduce intracranial pressure, can significantly improve the development of the disease and prognosis recovery. At present, the clinical diagnosis of cerebral edema is mainly through clinical manifestations and imaging examinations, and there is a lack of corresponding biological examination methods.Purpose of the study:1.By analyzing the correlation between serum SUR1, TRPM4, MMP-9 and the electromagnetic disturbance coefficient, cranial CT results, Glasgow coma score, S100-β, NSE and prognostic score at 3 months of discharge, the clinical value of serum SUR1, TRPM4, MMP-9 and perturbation coefficient in the diagnosis, intracranial pressure monitoring, condition assessment and prognosis judgment of cerebral edema in children was explored.2.By analyzing the changes of the above indicators in various children with cerebral edema admitted to PICU, the types of cerebral edema and the cellular and molecular mechanisms of cerebral edema caused by different diseases were explored.

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
12 Months 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Age 1-18 years old, male or female
  • Diagnosed with cerebral contusion/cerebral hemorrhage/intracranial tumor postoperative / intracranial infection/septic encephalopathy/metabolic encephalopathy.
  • The research purpose, significance, risks, benefits, and informed consent of patients and their families to the study.

排除标准

  • Critically ill and not suitable for research.
  • Those who are allergic to electrode sheets and do not cooperate.
  • Age> 18 years old or < 1 month.
  • Failure to obtain written permission from the guardian.

结局指标

主要结局

Serum MMP-9 concentration

时间窗: On days 1, 4, 7, and 14 of enrollment

Serum TRPM4 concentration

时间窗: On days 1, 4, 7, and 14 of enrollment

Perturbation coefficient monitored by noninvasive cerebral edema monitor

时间窗: On days 1, 4, 7, and 14 of enrollment

Serum SUR1 concentration

时间窗: On days 1, 4, 7, and 14 of enrollment

Area of cerebral edema as shown on cranial CT

时间窗: Day 1 of admission

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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