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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06017635
Other study ID # KYLL-202306-010
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date August 31, 2023
Est. completion date August 31, 2024

Study information

Verified date July 2023
Source Qilu Hospital of Shandong University
Contact Teng Wang
Phone 17861522291
Email w2311954128@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 264
Est. completion date August 31, 2024
Est. primary completion date March 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 12 Months to 18 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Exposure factors
General information Name, gender, age, weight (kg), major diseases 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-ß 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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Qilu Hospital of Shandong University

Outcome

Type Measure Description Time frame Safety issue
Primary Serum SUR1 concentration On days 1, 4, 7, and 14 of enrollment
Primary Serum TRPM4 concentration On days 1, 4, 7, and 14 of enrollment
Primary Serum MMP-9 concentration On days 1, 4, 7, and 14 of enrollment
Primary Perturbation coefficient monitored by noninvasive cerebral edema monitor On days 1, 4, 7, and 14 of enrollment
Primary Area of cerebral edema as shown on cranial CT Day 1 of admission
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