<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/NCT03765840</url>
  </required_header>
  <id_info>
    <org_study_id>POCD-aged</org_study_id>
    <nct_id>NCT03765840</nct_id>
  </id_info>
  <brief_title>Study of Postoperative Cognitive Decline in Aged Patients</brief_title>
  <official_title>Relationship Between Postoperative Cognitive Decline and Cytokines in Elderly Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jia-feng Wang</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Changhai Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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>
      postoperative cognitive decline is a common and deleterious complication in aged patients.The&#xD;
      link between inflammation and postoperative cognitive decline has also been&#xD;
      reported.However,the link between SOD1，SOD2，Osteopontin， Kallikrein-6，and Contactin-1 and&#xD;
      postoperative cognitive decline is unknown. In this project ,investigators examine the&#xD;
      relationship between 5 cytokines measured at there timepoints (preoperative [PREOP],&#xD;
      postoperative day 1 [POD1] , and postoperative day 3[POD2]) and postoperative cognitive&#xD;
      decline among older adults undergoing orthopedic surgery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 1, 2018</start_date>
  <completion_date type="Anticipated">May 2021</completion_date>
  <primary_completion_date type="Anticipated">May 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Differences in cytokines levels between the two groups</measure>
    <time_frame>preoperation</time_frame>
    <description>Compare differences in cytokines levels between the two groups</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Differences in cytokines levels between the two groups</measure>
    <time_frame>24h after operation</time_frame>
    <description>Compare differences in cytokines levels between the two groups</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Differences in cytokines levels between the two groups</measure>
    <time_frame>72h after operation</time_frame>
    <description>Compare differences in cytokines levels between the two groups</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Cognitive Decline</condition>
  <arm_group>
    <arm_group_label>POCD group</arm_group_label>
    <description>patients occur cognitive decline after surgery according to scores in this group.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NO POCD group</arm_group_label>
    <description>patients do not occur cognitive decline after surgery according to scores in this group.</description>
  </arm_group>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      blood of patients is collected preoperation and 24h after surgery and 72h after surgery&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        aged patients who recieve surgery for orthopedic surgery under spinal or general anesthesia&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients who are more than 65 years old&#xD;
&#xD;
          -  patients who undergo orthopedic surgery(trauma ,especially fracture of lower limb)&#xD;
&#xD;
          -  patients with ASA physical status I-III&#xD;
&#xD;
          -  patients who have a consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients who are more than 85 years old&#xD;
&#xD;
          -  patients with ASA physical status &gt;III&#xD;
&#xD;
          -  patients who have neurological disorders, stroke or other affective central nervous&#xD;
             system diseases&#xD;
&#xD;
          -  patients who have a history of serious psychiatric illness&#xD;
&#xD;
          -  patients with long-term use of psychoactive substances&#xD;
&#xD;
          -  patients who undergo multiple trauma and the presence of head injury&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>wenbin lu</last_name>
    <phone>86+21-31161841</phone>
    <email>13004162573@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Deartment of anesthesiology,changhai hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200433</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xi-Ya Yu, M.D.</last_name>
      <phone>+86-21-31161841</phone>
      <email>yuxiyash@163.com</email>
    </contact>
    <investigator>
      <last_name>Xi-Ya Yu, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 2, 2018</study_first_submitted>
  <study_first_submitted_qc>December 4, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 5, 2018</study_first_posted>
  <last_update_submitted>December 4, 2018</last_update_submitted>
  <last_update_submitted_qc>December 4, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 5, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Changhai Hospital</investigator_affiliation>
    <investigator_full_name>Jia-feng Wang</investigator_full_name>
    <investigator_title>M.D</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cognitive Dysfunction</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03765840
org study id: POCD-aged
nct id: NCT03765840
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
postoperative cognitive decline is a common and deleterious complication in aged patients.The
      link between inflammation and postoperative cognitive decline has also been
      reported.However,the link between SOD1，SOD2，Osteopontin， Kallikrein-6，and Contactin-1 and
      postoperative cognitive decline is unknown. In this project ,investigators examine the
      relationship between 5 cytokines measured at there timepoints (preoperative [PREOP],
      postoperative day 1 [POD1] , and postoperative day 3[POD2]) and postoperative cognitive
      decline among older adults undergoing orthopedic surgery.
observational model: Case-Control
time perspective: Prospective
measure: Differences in cytokines levels between the two groups
time frame: preoperation
description: Compare differences in cytokines levels between the two groups
measure: Differences in cytokines levels between the two groups
time frame: 24h after operation
description: Compare differences in cytokines levels between the two groups
measure: Differences in cytokines levels between the two groups
time frame: 72h after operation
description: Compare differences in cytokines levels between the two groups
arm group label: POCD group
description: patients occur cognitive decline after surgery according to scores in this group.
arm group label: NO POCD group
description: patients do not occur cognitive decline after surgery according to scores in this group.
blood of patients is collected preoperation and 24h after surgery and 72h after surgery
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 65 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
last name: wenbin lu
phone: 86+21-31161841
email: 13004162573@163.com
facility: 
status: Recruiting
contact: 
investigator: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Changhai Hospital
investigator full name: Jia-feng Wang
investigator title: M.D
mesh term: Cognitive Dysfunction