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

August 27, 2023 updated by: Qilu Hospital of Shandong University
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

264

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Children whose PICU income meets the inclusion criteria

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Other: Exposure factors
  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.
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.
Other: Exposure factors
  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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Serum SUR1 concentration
Time Frame: On days 1, 4, 7, and 14 of enrollment
On days 1, 4, 7, and 14 of enrollment
Serum TRPM4 concentration
Time Frame: On days 1, 4, 7, and 14 of enrollment
On days 1, 4, 7, and 14 of enrollment
Serum MMP-9 concentration
Time Frame: On days 1, 4, 7, and 14 of enrollment
On days 1, 4, 7, and 14 of enrollment
Perturbation coefficient monitored by noninvasive cerebral edema monitor
Time Frame: On days 1, 4, 7, and 14 of enrollment
On days 1, 4, 7, and 14 of enrollment
Area of cerebral edema as shown on cranial CT
Time Frame: Day 1 of admission
Day 1 of admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qilu Hospital of Shandong University

Investigators

  • Study Director: XinJie Liu, Director of Qilu Hospital of Shandong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 31, 2023

Primary Completion (Estimated)

March 1, 2024

Study Completion (Estimated)

August 31, 2024

Study Registration Dates

First Submitted

August 1, 2023

First Submitted That Met QC Criteria

August 27, 2023

First Posted (Actual)

August 30, 2023

Study Record Updates

Last Update Posted (Actual)

August 30, 2023

Last Update Submitted That Met QC Criteria

August 27, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KYLL-202306-010

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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