Clinical trial NCT06017635: Non-invasive Monitoring and Serum Marker Study in Children With Cerebral Edema
Official title: Non-invasive Monitoring and Serum Marker Study in Children With Cerebral Edema
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Brain Edema
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
First posted: 2023-08-30
Enrollment: 264
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children whose PICU income meets the inclusion criteria

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Serum SUR1 concentration
timeFrame: On days 1, 4, 7, and 14 of enrollment
measure: Serum TRPM4 concentration
timeFrame: On days 1, 4, 7, and 14 of enrollment
measure: Serum MMP-9 concentration
timeFrame: On days 1, 4, 7, and 14 of enrollment
measure: Perturbation coefficient monitored by noninvasive cerebral edema monitor
timeFrame: On days 1, 4, 7, and 14 of enrollment
measure: Area of cerebral edema as shown on cranial CT
timeFrame: Day 1 of admission
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Director of Qilu Hospital of Shandong University
name: XinJie Liu
role: STUDY_DIRECTOR
References: