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/NCT06007755</url>
    </required_header>
    <id_info>
      <org_study_id>TJMZK202301</org_study_id>
      <nct_id>NCT06007755</nct_id>
    </id_info>
    <brief_title>Exploring of Serum Biomarkers of Delirium After Cardiovascular Surgery</brief_title>
    <official_title>Exploring of Serum Biomarkers of Delirium After Cardiovascular Surgery</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Huazhong University of Science and Technology</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Huazhong University of Science and Technology</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>
        The incidence of postoperative delirium in patients after cardiovascular surgery is very&#xD;
        high, which seriously affects the short-term and long-term prognosis of patients, but its&#xD;
        mechanism is not clear. Recent studies have found that lactic acid participates in the&#xD;
        process of sepsis by inducing histone lactatation in macrophages. histone H3 lysine 18&#xD;
        lactylation (H3K18la) is significantly associated with the severity of disease and&#xD;
        inflammatory response. Inflammation plays an important role in postoperative delirium. We&#xD;
        therefore hypothesized that macrophage H3K18la also plays a role in postoperative delirium.At&#xD;
        the same time, the latest literature shows that the early markers of Alzheimer's disease&#xD;
        (AD), such as exosomes and phosphorylated tau396, 404, etc. [5], can also be detected in the&#xD;
        serum of AD patients. Given the obvious correlation between Alzheimer's disease and&#xD;
        postoperative delirium [6], we hypothesized that serum phosphorylated exosome and&#xD;
        phosphorylated tau396,404 could also be used as serum biomarkers for postoperative delirium.&#xD;
  &#xD;
        The objectives of this study were to investigate the correlation between H3K18 in serum&#xD;
        monocytes and postoperative delirium and its severity in patients undergoing cardiovascular&#xD;
        surgery under cardiopulmonary bypass. Meanwhile, we also detect the serum levels of exosome&#xD;
        and phosphorylated tau396,404 in patients undergoing major cardiac surgery. We aim to find&#xD;
        the serum biomarkers of delirium after major cardiac surgery, so as to provide a more&#xD;
        convenient diagnostic basis for the prevention of postoperative delirium.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">October 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>Association of H3K18 with postoperative delirium and its severity in patients undergoing cardiovascular surgery under cardiopulmonary bypass</measure>
      <time_frame>Perioperative data</time_frame>
    </primary_outcome>
    <enrollment type="Anticipated">113</enrollment>
    <condition>Delirium</condition>
    <eligibility>
      <study_pop>
        <textblock>
          Patients aged over 18 years undergoing elective cardiovascular surgery under&#xD;
          cardiopulmonary bypass&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          patients who receive elective cardiovascular surgery under cardiopulmonary bypass&#xD;
  &#xD;
            -  Patients participated voluntarily and signed informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  past medical history of neurological and psychiatric diseases; severe visual or&#xD;
               hearing impairment;&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 16, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 23, 2023</last_update_submitted>
    <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Huazhong University of Science and Technology</investigator_affiliation>
      <investigator_full_name>Hua Zheng</investigator_full_name>
      <investigator_title>Associate Professor</investigator_title>
    </responsible_party>
    <keyword>delirium</keyword>
    <keyword>biomarker</keyword>
    <keyword>cardiovascular surgery</keyword>
    <keyword>H3K18la</keyword>
    <keyword>exosome</keyword>
    <keyword>phospho-tau</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Delirium</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/NCT06007755
  org study id: TJMZK202301
  nct id: NCT06007755
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The incidence of postoperative delirium in patients after cardiovascular surgery is very
        high, which seriously affects the short-term and long-term prognosis of patients, but its
        mechanism is not clear. Recent studies have found that lactic acid participates in the
        process of sepsis by inducing histone lactatation in macrophages. histone H3 lysine 18
        lactylation (H3K18la) is significantly associated with the severity of disease and
        inflammatory response. Inflammation plays an important role in postoperative delirium. We
        therefore hypothesized that macrophage H3K18la also plays a role in postoperative delirium.At
        the same time, the latest literature shows that the early markers of Alzheimer's disease
        (AD), such as exosomes and phosphorylated tau396, 404, etc. [5], can also be detected in the
        serum of AD patients. Given the obvious correlation between Alzheimer's disease and
        postoperative delirium [6], we hypothesized that serum phosphorylated exosome and
        phosphorylated tau396,404 could also be used as serum biomarkers for postoperative delirium.
  
        The objectives of this study were to investigate the correlation between H3K18 in serum
        monocytes and postoperative delirium and its severity in patients undergoing cardiovascular
        surgery under cardiopulmonary bypass. Meanwhile, we also detect the serum levels of exosome
        and phosphorylated tau396,404 in patients undergoing major cardiac surgery. We aim to find
        the serum biomarkers of delirium after major cardiac surgery, so as to provide a more
        convenient diagnostic basis for the prevention of postoperative delirium.
  observational model: Cohort
  time perspective: Prospective
  measure: Association of H3K18 with postoperative delirium and its severity in patients undergoing cardiovascular surgery under cardiopulmonary bypass
  time frame: Perioperative data
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  responsible party type: Principal Investigator
  investigator affiliation: Huazhong University of Science and Technology
  investigator full name: Hua Zheng
  investigator title: Associate Professor
  mesh term: Delirium