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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Qilu Hospital of Shandong University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 31, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 1, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 27, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 30, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 30, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 27, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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