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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06017635
Enrollment
264
Registered
2023-08-30
Start date
2023-08-31
Completion date
2024-08-31
Last updated
2023-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Edema

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.

Interventions

1. General information Name, gender, age, weight (kg), major diseases 2. Clinical data: Non-contrast CT scan results of cranial CT on the first day of admission, serum SUR1, trpm4 and MMP-9 expression on the 1st, 4th, 7th and 14th days of admission, S100-β and NSE values on the 1st, 4th, 7th, and 14th days of admission, disturbance coefficient on the 1st, 4th, 7th, and 14th days of admission, Glasgow coma score on the 1st, 4th, 7th, and 14th days of admission, GOS-E score and Merriam-Webster Intelligence Scale score at 3 months of discharge.

Sponsors

Qilu Hospital of Shandong University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
12 Months to 18 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frame
Serum SUR1 concentrationOn days 1, 4, 7, and 14 of enrollment
Serum TRPM4 concentrationOn days 1, 4, 7, and 14 of enrollment
Serum MMP-9 concentrationOn days 1, 4, 7, and 14 of enrollment
Perturbation coefficient monitored by noninvasive cerebral edema monitorOn days 1, 4, 7, and 14 of enrollment
Area of cerebral edema as shown on cranial CTDay 1 of admission

Contacts

Primary ContactTeng Wang
w2311954128@163.com17861522291
Backup ContactXinJie Liu
liuxinjie-ert@163.com18560086300

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026