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/NCT05991830</url>
    </required_header>
    <id_info>
      <org_study_id>OAIC: 1311/22</org_study_id>
      <nct_id>NCT05991830</nct_id>
    </id_info>
    <brief_title>Inflammatory Markers and Level of Cortical Hyperactivity</brief_title>
    <acronym>IMCH</acronym>
    <official_title>Determination of Inflammatory Markers and Level of Cortical Hyperactivity in Older Adults Undergoing Elective Surgery</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Chile</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Chile</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Alzheimer's disease (AD) is a progressive and fatal neurodegenerative disease that is&#xD;
        manifested by severe cognitive impairment mainly from late life (&gt;65 years). Clinical studies&#xD;
        have shown that both systemic inflammation and cortical and hippocampal hyperactivity are&#xD;
        features present in patients during the early stages of the disease. In this project we will&#xD;
        seek to relate the levels of the proinflammatory cytokines interleukin-1beta, interleukin-6&#xD;
        and tumor necrosis factor-alpha with the level of cortical hyperactivity evaluated with the&#xD;
        electroencephalographic changes induced by the GABAergic anesthetic propofol in older adults&#xD;
        undergoing elective surgery.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Alzheimer's disease (AD) is a progressive and fatal neurodegenerative disease that is&#xD;
        manifested by severe cognitive impairment mainly from late life (&gt;65 years). It is now known&#xD;
        that markers of damage begin decades before symptoms can be detected, at the stage called&#xD;
        preclinical early AD, which progresses inexorably to mild cognitive impairment and ends in&#xD;
        severe Alzheimer's dementia. Clinical studies have shown that both systemic inflammation and&#xD;
        cortical and hippocampal hyperactivity are features present in patients during the early&#xD;
        stages of the disease, however, they have not been directly related in a clinical context. In&#xD;
        this project we will seek to relate the levels of the proinflammatory cytokines IL-1beta,&#xD;
        IL-6 and TNF-alpha with the level of cortical hyperactivity evaluated with the&#xD;
        electroencephalographic changes induced by the GABAergic anesthetic propofol in older adults&#xD;
        undergoing elective surgery. The main goal of this project is to determine the levels of&#xD;
        inflammatory markers and cortical hyperactivity in older adults. Methodology: the project is&#xD;
        an exploratory observational study of a prospective cohort of patients &gt; 60 years of age who&#xD;
        will undergo elective surgery under general anesthesia. In the preoperative period,&#xD;
        peripheral venous blood samples will be obtained and stored at -80 ° C and then analyzed by&#xD;
        the SIMOA® analyzer, fully automated and digital equipment for performing immunoassays, based&#xD;
        on SIMOA® technology, which provide an ultrasensitive signal and / or measurement up to 1000&#xD;
        times greater than conventional immunoassays (in the femtomolar range) of proteins. On the&#xD;
        other hand, EEG signal at 128 Hz and other variables from BIS® monitor will be recorded to&#xD;
        determine the level of cortical hyperactivity.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 1, 2023</start_date>
    <completion_date type="Anticipated">September 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">July 31, 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>MoCA score</measure>
      <time_frame>Baseline (Day 0)</time_frame>
      <description>Score (0 to 30)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Intraoperative EEG</measure>
      <time_frame>Intraoperative (Day 0)</time_frame>
      <description>EEG parameters</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Aβ40</measure>
      <time_frame>Baseline (Day 0)</time_frame>
      <description>Aβ40 plasma concentration</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Aβ42</measure>
      <time_frame>Baseline (Day 0)</time_frame>
      <description>Aβ42 plasma concentration</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>GFAP™</measure>
      <time_frame>Baseline (Day 0)</time_frame>
      <description>Glial Fibrillary Acidic Protein (GFAP™) plasma concentration</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Nf-L</measure>
      <time_frame>Baseline (Day 0)</time_frame>
      <description>Neurofilament light (Nf-L) plasma concentration</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Cognition Disorder</condition>
    <arm_group>
      <arm_group_label>Older adults &gt; 60 years</arm_group_label>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>General anesthesia</intervention_name>
      <description>Older adults during elective surgery under general anesthesia with propofol, frontal EEG will recorded and a baseline plasma sample will be taken</description>
      <arm_group_label>Older adults &gt; 60 years</arm_group_label>
    </intervention>
    <biospec_retention>Samples Without DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        Plasma&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          Cohort of patients &gt; 60 years of age who will undergo elective surgery under general&#xD;
          anesthesia&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Adults over 60 years of age undergoing elective surgery&#xD;
  &#xD;
            2. Able to understand and sign an informed consent form&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Diagnosis of other neurological pathologies&#xD;
  &#xD;
            2. No active acute or chronic decompensated diseases&#xD;
  &#xD;
            3. No severe psychiatric illnesses&#xD;
  &#xD;
            4. Propofol allergy&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>60 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
    </eligibility>
    <overall_official>
      <last_name>Pedro Lobos, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Chile</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Antonello Penna, MD, PhD</last_name>
      <role>Study Chair</role>
      <affiliation>University of Chile</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Antonello Penna, MD, PhD</last_name>
      <phone>+56956766623</phone>
      <email>apenna@uchile.cl</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Pedro Lobos, PhD</last_name>
      <phone>+56982404674</phone>
      <email>ploboszqf@gmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Centro de Investigación Cínica Avanzada (CICA), Hospital Clinico de la Universidad de Chile</name>
        <address>
          <city>Santiago</city>
          <state>RM</state>
          <zip>7690306</zip>
          <country>Chile</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Daniela Ponce, Ing</last_name>
        <phone>56229789405</phone>
        <email>dponcedelavega@gmail.com</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Hospital Clinico de la Universidad de Chile</name>
        <address>
          <city>Santiago</city>
          <state>RM</state>
          <zip>7690306</zip>
          <country>Chile</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location_countries>
      <country>Chile</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 7, 2023</study_first_submitted>
    <study_first_submitted_qc>August 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>August 7, 2023</last_update_submitted>
    <last_update_submitted_qc>August 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 15, 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>Cognition Disorders</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Anesthetics</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
      <ipd_description>Data will be shared based on individual requests made directly to study investigators</ipd_description>
    </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/NCT05991830
  org study id: OAIC: 1311/22
  nct id: NCT05991830
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Alzheimer's disease (AD) is a progressive and fatal neurodegenerative disease that is
        manifested by severe cognitive impairment mainly from late life (>65 years). Clinical studies
        have shown that both systemic inflammation and cortical and hippocampal hyperactivity are
        features present in patients during the early stages of the disease. In this project we will
        seek to relate the levels of the proinflammatory cytokines interleukin-1beta, interleukin-6
        and tumor necrosis factor-alpha with the level of cortical hyperactivity evaluated with the
        electroencephalographic changes induced by the GABAergic anesthetic propofol in older adults
        undergoing elective surgery.
  Alzheimer's disease (AD) is a progressive and fatal neurodegenerative disease that is
        manifested by severe cognitive impairment mainly from late life (>65 years). It is now known
        that markers of damage begin decades before symptoms can be detected, at the stage called
        preclinical early AD, which progresses inexorably to mild cognitive impairment and ends in
        severe Alzheimer's dementia. Clinical studies have shown that both systemic inflammation and
        cortical and hippocampal hyperactivity are features present in patients during the early
        stages of the disease, however, they have not been directly related in a clinical context. In
        this project we will seek to relate the levels of the proinflammatory cytokines IL-1beta,
        IL-6 and TNF-alpha with the level of cortical hyperactivity evaluated with the
        electroencephalographic changes induced by the GABAergic anesthetic propofol in older adults
        undergoing elective surgery. The main goal of this project is to determine the levels of
        inflammatory markers and cortical hyperactivity in older adults. Methodology: the project is
        an exploratory observational study of a prospective cohort of patients > 60 years of age who
        will undergo elective surgery under general anesthesia. In the preoperative period,
        peripheral venous blood samples will be obtained and stored at -80 ° C and then analyzed by
        the SIMOA® analyzer, fully automated and digital equipment for performing immunoassays, based
        on SIMOA® technology, which provide an ultrasensitive signal and / or measurement up to 1000
        times greater than conventional immunoassays (in the femtomolar range) of proteins. On the
        other hand, EEG signal at 128 Hz and other variables from BIS® monitor will be recorded to
        determine the level of cortical hyperactivity.
  observational model: Cohort
  time perspective: Prospective
  measure: MoCA score
  time frame: Baseline (Day 0)
  description: Score (0 to 30)
  measure: Intraoperative EEG
  time frame: Intraoperative (Day 0)
  description: EEG parameters
  measure: Aβ40
  time frame: Baseline (Day 0)
  description: Aβ40 plasma concentration
  measure: Aβ42
  time frame: Baseline (Day 0)
  description: Aβ42 plasma concentration
  measure: GFAP™
  time frame: Baseline (Day 0)
  description: Glial Fibrillary Acidic Protein (GFAP™) plasma concentration
  measure: Nf-L
  time frame: Baseline (Day 0)
  description: Neurofilament light (Nf-L) plasma concentration
  arm group label: Older adults > 60 years
  intervention type: Procedure
  intervention name: General anesthesia
  description: Older adults during elective surgery under general anesthesia with propofol, frontal EEG will recorded and a baseline plasma sample will be taken
  arm group label: Older adults > 60 years
  Plasma
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 60 Years
  maximum age: 80 Years
  last name: Pedro Lobos, PhD
  role: Principal Investigator
  affiliation: University of Chile
  last name: Antonello Penna, MD, PhD
  role: Study Chair
  affiliation: University of Chile
  last name: Antonello Penna, MD, PhD
  phone: +56956766623
  email: apenna@uchile.cl
  last name: Pedro Lobos, PhD
  phone: +56982404674
  email: ploboszqf@gmail.com
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  country: Chile
  responsible party type: Sponsor
  mesh term: Cognition Disorders
  mesh term: Anesthetics
  sharing ipd: Undecided
  ipd description: Data will be shared based on individual requests made directly to study investigators