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/NCT05972057</url>
    </required_header>
    <id_info>
      <org_study_id>PPSB</org_study_id>
      <nct_id>NCT05972057</nct_id>
    </id_info>
    <brief_title>Prediction Model of Long-term Cognitive Dysfunction and Delirium After Cardiac Surgery</brief_title>
    <official_title>A Prediction Model of Long-term Postoperative Cognitive Dysfunction and Delirium After Cardiac Surgery Based on Peripheral Blood Biomarkers： A Prospective Cohort Study(PPSB)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>RenJi Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>RenJi Hospital</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>
        Delirium is a clinical syndrome caused by normal dysfunction of the brain, characterized by&#xD;
        reduced awareness and responsiveness to the environment, as well as orientation disorders,&#xD;
        incoherent thinking and memory disorders. Delirium indicates poor recovery of cognitive&#xD;
        function, decreased ability of daily life, may need to enter nursing homes, and even lead to&#xD;
        adverse outcomes such as death. According to a number of clinical studies, middle-aged and&#xD;
        elderly people are prone to delirium after undergoing major surgery. Delirium occurs in 31 %&#xD;
        -40 % of patients over 50 years old after cardiac surgery. Compared with patients without&#xD;
        postoperative delirium, patients with postoperative delirium had significant cognitive&#xD;
        impairment within 1 year after cardiac surgery. The occurrence of delirium suggests that the&#xD;
        patient 's brain has become fragile, cognitive function has begun to decline, and the risk of&#xD;
        future dementia has increased.&#xD;
  &#xD;
        Secondly, delirium and dementia have overlapping clinical features and common pathogenic&#xD;
        mechanisms. Some scholars even speculate that delirium and dementia represent different&#xD;
        stages of a common process. It is generally believed that the peripheral immune system may be&#xD;
        involved in the pathogenesis and progression of dementia through the dysfunctional&#xD;
        blood-brain barrier. The activation of microglia and astrocytes leads to the release of&#xD;
        chemokines, which can recruit peripheral immune cells to the central nervous system. At the&#xD;
        same time, cytokines released by peripheral cells can cross the blood-brain barrier and act&#xD;
        on glial cells to change their phenotype.&#xD;
  &#xD;
        This study is a prospective cohort study of patients aged 65 and over who are about to&#xD;
        undergo elective cardiac surgery.CyTOF can achieve accurate immunophenotyping of cell&#xD;
        populations while comprehensively and accurately detecting and analyzing cytokines and&#xD;
        signaling pathways. Therefore, the detection of peripheral blood biomarkers may effectively&#xD;
        predict the risk of long-term cognitive dysfunction and postoperative delirium in patients&#xD;
        undergoing cardiac surgery.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 1, 2023</start_date>
    <completion_date type="Anticipated">July 30, 2025</completion_date>
    <primary_completion_date type="Anticipated">July 29, 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>postoperative delirium</measure>
      <time_frame>up to 5 days after surgery</time_frame>
      <description>To establish a risk factor prediction model for postoperative delirium in patients aged 65 and over undergoing elective cardiac surgery by detecting peripheral blood biomarkers by CyTOF.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>long-term cognitive dysfunction</measure>
      <time_frame>1 year after surgery</time_frame>
      <description>To establish a risk factor prediction model for long-term cognitive impairment in patients aged 65 and over undergoing elective cardiac surgery by detecting peripheral blood biomarkers by CyTOF.</description>
    </secondary_outcome>
    <enrollment type="Anticipated">200</enrollment>
    <condition>Delirium</condition>
    <condition>Cognitive Dysfunction</condition>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>cardiac surgery</intervention_name>
      <description>All cardiac surgery patients who met the inclusion criteria were included in the cardiac surgery department of Renji Hospital.</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          During the implementation of the project, all patients with cardiac surgery who met the&#xD;
          inclusion criteria were included in the Department of Cardiac Surgery of Renji Hospital.&#xD;
          The total sample size was the sum of all patients by the project deadline.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age ≥ 65 years&#xD;
  &#xD;
            -  Patients undergoing elective cardiac surgery with cardiopulmonary bypass&#xD;
  &#xD;
            -  Sign informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  serious dementia, encephalopathy, mental illness or other neurological diseases&#xD;
  &#xD;
            -  Patients who could not take neurocognitive tests due to other reasons ( such as&#xD;
               language, hearing or visual impairment )&#xD;
  &#xD;
            -  Patients with stage 3 or 4 malignant tumors, and patients with pancreatic cancer,&#xD;
               gallbladder cancer, cholangiocarcinoma and other tumors with high malignancy and&#xD;
               expected survival time less than 1 year&#xD;
  &#xD;
            -  American Society of Anesthesiologists ( ASA ) classification IV or V patients&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>65 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
    </eligibility>
    <overall_contact>
      <last_name>Li Peiying, Ph.D.</last_name>
      <phone>+8615800616866</phone>
      <email>peiyingli.md@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Renji Hospital, Shanghai Jiao Tong University, School of Medicine</name>
        <address>
          <city>Shanghai</city>
          <state>Shanghai</state>
          <zip>200127</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>DAN HUANG, MS</last_name>
        <phone>+8615921108822</phone>
        <email>huangdan@renji.com</email>
      </contact>
      <contact_backup>
        <last_name>XIA JIN, PD</last_name>
        <phone>+8618094575236</phone>
        <email>jinxia026779@renji.com</email>
      </contact_backup>
      <investigator>
        <last_name>DAN HUANG, MS</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>April 6, 2023</study_first_submitted>
    <study_first_submitted_qc>July 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>September 6, 2023</last_update_submitted>
    <last_update_submitted_qc>September 6, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 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>Delirium</mesh_term>
      <mesh_term>Cognitive Dysfunction</mesh_term>
    </condition_browse>
    <!-- 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/NCT05972057
  org study id: PPSB
  nct id: NCT05972057
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Delirium is a clinical syndrome caused by normal dysfunction of the brain, characterized by
        reduced awareness and responsiveness to the environment, as well as orientation disorders,
        incoherent thinking and memory disorders. Delirium indicates poor recovery of cognitive
        function, decreased ability of daily life, may need to enter nursing homes, and even lead to
        adverse outcomes such as death. According to a number of clinical studies, middle-aged and
        elderly people are prone to delirium after undergoing major surgery. Delirium occurs in 31 %
        -40 % of patients over 50 years old after cardiac surgery. Compared with patients without
        postoperative delirium, patients with postoperative delirium had significant cognitive
        impairment within 1 year after cardiac surgery. The occurrence of delirium suggests that the
        patient 's brain has become fragile, cognitive function has begun to decline, and the risk of
        future dementia has increased.
  
        Secondly, delirium and dementia have overlapping clinical features and common pathogenic
        mechanisms. Some scholars even speculate that delirium and dementia represent different
        stages of a common process. It is generally believed that the peripheral immune system may be
        involved in the pathogenesis and progression of dementia through the dysfunctional
        blood-brain barrier. The activation of microglia and astrocytes leads to the release of
        chemokines, which can recruit peripheral immune cells to the central nervous system. At the
        same time, cytokines released by peripheral cells can cross the blood-brain barrier and act
        on glial cells to change their phenotype.
  
        This study is a prospective cohort study of patients aged 65 and over who are about to
        undergo elective cardiac surgery.CyTOF can achieve accurate immunophenotyping of cell
        populations while comprehensively and accurately detecting and analyzing cytokines and
        signaling pathways. Therefore, the detection of peripheral blood biomarkers may effectively
        predict the risk of long-term cognitive dysfunction and postoperative delirium in patients
        undergoing cardiac surgery.
  observational model: Cohort
  time perspective: Prospective
  measure: postoperative delirium
  time frame: up to 5 days after surgery
  description: To establish a risk factor prediction model for postoperative delirium in patients aged 65 and over undergoing elective cardiac surgery by detecting peripheral blood biomarkers by CyTOF.
  measure: long-term cognitive dysfunction
  time frame: 1 year after surgery
  description: To establish a risk factor prediction model for long-term cognitive impairment in patients aged 65 and over undergoing elective cardiac surgery by detecting peripheral blood biomarkers by CyTOF.
  intervention type: Procedure
  intervention name: cardiac surgery
  description: All cardiac surgery patients who met the inclusion criteria were included in the cardiac surgery department of Renji Hospital.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 65 Years
  maximum age: N/A
  last name: Li Peiying, Ph.D.
  phone: +8615800616866
  email: peiyingli.md@gmail.com
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  country: China
  responsible party type: Sponsor
  mesh term: Delirium
  mesh term: Cognitive Dysfunction