xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06017635</url>
    </required_header>
    <id_info>
      <org_study_id>KYLL-202306-010</org_study_id>
      <nct_id>NCT06017635</nct_id>
    </id_info>
    <brief_title>Non-invasive Monitoring and Serum Marker Study in Children With Cerebral Edema</brief_title>
    <official_title>Non-invasive Monitoring and Serum Marker Study in Children With Cerebral Edema</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Qilu Hospital of Shandong University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Qilu Hospital of Shandong University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Purpose of the study：This study aimed to evaluate the clinical significance of serum SUR1,&#xD;
        TRPM4 and MMP-9 in the diagnosis of cerebral edema in children with cerebral edema admitted&#xD;
        to PICU by comparing them with CT results and perturbation coefficients, so as to provide&#xD;
        biological indicators for clinical diagnosis of cerebral edema and provide targets for the&#xD;
        treatment of cerebral edema in various diseases.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Early and efficient use of various measures to control and monitor peripheral cerebral edema&#xD;
        and intracranial pressure, timely and accurate adjustment of treatment plan to reduce the&#xD;
        degree of cerebral edema and reduce intracranial pressure, can significantly improve the&#xD;
        development of the disease and prognosis recovery. At present, the clinical diagnosis of&#xD;
        cerebral edema is mainly through clinical manifestations and imaging examinations, and there&#xD;
        is a lack of corresponding biological examination methods.Purpose of the study：1.By analyzing&#xD;
        the correlation between serum SUR1, TRPM4, MMP-9 and the electromagnetic disturbance&#xD;
        coefficient, cranial CT results, Glasgow coma score, S100-β, NSE and prognostic score at 3&#xD;
        months of discharge, the clinical value of serum SUR1, TRPM4, MMP-9 and perturbation&#xD;
        coefficient in the diagnosis, intracranial pressure monitoring, condition assessment and&#xD;
        prognosis judgment of cerebral edema in children was explored.2.By analyzing the changes of&#xD;
        the above indicators in various children with cerebral edema admitted to PICU, the types of&#xD;
        cerebral edema and the cellular and molecular mechanisms of cerebral edema caused by&#xD;
        different diseases were explored.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 31, 2023</start_date>
    <completion_date type="Anticipated">August 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">March 1, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Serum SUR1 concentration</measure>
      <time_frame>On days 1, 4, 7, and 14 of enrollment</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Serum TRPM4 concentration</measure>
      <time_frame>On days 1, 4, 7, and 14 of enrollment</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Serum MMP-9 concentration</measure>
      <time_frame>On days 1, 4, 7, and 14 of enrollment</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Perturbation coefficient monitored by noninvasive cerebral edema monitor</measure>
      <time_frame>On days 1, 4, 7, and 14 of enrollment</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Area of cerebral edema as shown on cranial CT</measure>
      <time_frame>Day 1 of admission</time_frame>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">264</enrollment>
    <condition>Brain Edema</condition>
    <arm_group>
      <arm_group_label>Case</arm_group_label>
      <description>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.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Contral</arm_group_label>
      <description>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.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Exposure factors</intervention_name>
      <description>General information Name, gender, age, weight (kg), major diseases&#xD;
  Clinical data:&#xD;
  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.</description>
      <arm_group_label>Case</arm_group_label>
      <arm_group_label>Contral</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Children whose PICU income meets the inclusion criteria&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age 1-18 years old, male or female&#xD;
  &#xD;
            -  Diagnosed with cerebral contusion/cerebral hemorrhage/intracranial tumor postoperative&#xD;
               / intracranial infection/septic encephalopathy/metabolic encephalopathy.&#xD;
  &#xD;
            -  The research purpose, significance, risks, benefits, and informed consent of patients&#xD;
               and their families to the study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Critically ill and not suitable for research.&#xD;
  &#xD;
            -  Those who are allergic to electrode sheets and do not cooperate.&#xD;
  &#xD;
            -  Age&gt; 18 years old or &lt; 1 month.&#xD;
  &#xD;
            -  Failure to obtain written permission from the guardian.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>12 Months</minimum_age>
      <maximum_age>18 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>XinJie Liu</last_name>
      <role>Study Director</role>
      <affiliation>Director of Qilu Hospital of Shandong University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Teng Wang</last_name>
      <phone>17861522291</phone>
      <email>w2311954128@163.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>XinJie Liu</last_name>
      <phone>18560086300</phone>
      <email>liuxinjie-ert@163.com</email>
    </overall_contact_backup>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>August 1, 2023</study_first_submitted>
    <study_first_submitted_qc>August 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 30, 2023</study_first_posted>
    <last_update_submitted>August 27, 2023</last_update_submitted>
    <last_update_submitted_qc>August 27, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Brain Edema</mesh_term>
      <mesh_term>Edema</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06017635
  org study id: KYLL-202306-010
  nct id: NCT06017635
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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.
  observational model: Cohort
  time perspective: Prospective
  measure: Serum SUR1 concentration
  time frame: On days 1, 4, 7, and 14 of enrollment
  measure: Serum TRPM4 concentration
  time frame: On days 1, 4, 7, and 14 of enrollment
  measure: Serum MMP-9 concentration
  time frame: On days 1, 4, 7, and 14 of enrollment
  measure: Perturbation coefficient monitored by noninvasive cerebral edema monitor
  time frame: On days 1, 4, 7, and 14 of enrollment
  measure: Area of cerebral edema as shown on cranial CT
  time frame: Day 1 of admission
  arm group label: Case
  description: 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.
  arm group label: Contral
  description: 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.
  intervention type: Other
  intervention name: Exposure factors
  description: 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-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.
  arm group label: Case
  arm group label: Contral
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 12 Months
  maximum age: 18 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: XinJie Liu
  role: Study Director
  affiliation: Director of Qilu Hospital of Shandong University
  last name: Teng Wang
  phone: 17861522291
  email: w2311954128@163.com
  last name: XinJie Liu
  phone: 18560086300
  email: liuxinjie-ert@163.com
  responsible party type: Sponsor
  mesh term: Brain Edema
  mesh term: Edema
  sharing ipd: No