Non-invasive Monitoring and Serum Marker Study in Children With Cerebral Edema
1 other identifier
observational
264
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2023
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 1, 2023
CompletedFirst Posted
Study publicly available on registry
August 30, 2023
CompletedStudy Start
First participant enrolled
August 31, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2024
CompletedAugust 30, 2023
July 1, 2023
6 months
August 1, 2023
August 27, 2023
Conditions
Outcome Measures
Primary Outcomes (5)
Serum SUR1 concentration
On days 1, 4, 7, and 14 of enrollment
Serum TRPM4 concentration
On days 1, 4, 7, and 14 of enrollment
Serum MMP-9 concentration
On days 1, 4, 7, and 14 of enrollment
Perturbation coefficient monitored by noninvasive cerebral edema monitor
On days 1, 4, 7, and 14 of enrollment
Area of cerebral edema as shown on cranial CT
Day 1 of admission
Study Arms (2)
Case
1\. Age 1-18 years old, male or female. 2. Diagnosed with cerebral contusion/cerebral hemorrhage/intracranial tumor postoperative / intracranial infection/septic encephalopathy/metabolic encephalopathy. 3. The research purpose, significance, risks, benefits, and informed consent of patients and their families to the study.
Contral
1\. Age 1-18 years old, male or female. 2. Non-cranial organic injury diseases. 3. Physical condition allows them to participate in the study. 4. The research purpose, significance, risks, benefits, and informed consent of patients and their families to the study.
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.
Eligibility Criteria
Children whose PICU income meets the inclusion criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
XinJie Liu
Director of Qilu Hospital of Shandong University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 1, 2023
First Posted
August 30, 2023
Study Start
August 31, 2023
Primary Completion
March 1, 2024
Study Completion
August 31, 2024
Last Updated
August 30, 2023
Record last verified: 2023-07
Data Sharing
- IPD Sharing
- Will not share