<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/NCT04484922</url>
  </required_header>
  <id_info>
    <org_study_id>2001-062-1095</org_study_id>
    <nct_id>NCT04484922</nct_id>
  </id_info>
  <brief_title>Dexmedetomidine Neuroprotection in Pediatric Cardiac Surgery</brief_title>
  <official_title>The Effect of Dexmedetomidine on Neuroprotection in Pediatric Cardiac Surgery Patients: a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University 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>
      Neurodevelopmental disability is the most significant complication for survivors of infant&#xD;
      surgery for congenital heart disease. In this study we sought to determine if intraoperative&#xD;
      continuous infusion of dexmedetomidine are associated with neurodevelopmental outcomes at 12&#xD;
      months.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 25, 2020</start_date>
  <completion_date type="Anticipated">May 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">May 31, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Bayley scales of Infant development</measure>
    <time_frame>1 year after the surgery</time_frame>
    <description>Developmental outcomes at each assessment and within each domain (cognitive, language, and motor) were classified as &quot;average&quot; if they were within 1 SD of the mean or higher (scores .85), &quot;at risk&quot; if they were 1 to 2 SD below the mean (scores 70-84), and &quot;delayed&quot; if they were .2SD below the mean (,70). The trajectory of development over time in each domain (cognitive, language, and motor)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>neurodevelopment biomarker</measure>
    <time_frame>intraoperative (before skin incision, end of hypothermia, end of cardiopulmonary bypass), 4 hours after end of surgery</time_frame>
    <description>plasma glial fibrillary acidic protein concentration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>inflammation</measure>
    <time_frame>4 hours after end of surgery</time_frame>
    <description>level of IL-6</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>acute kidney injury</measure>
    <time_frame>2 hours after end of cardiopulmonary bypass</time_frame>
    <description>urinary NGAL</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>myocardial injury</measure>
    <time_frame>intraoperative (before skin incision, end of cardiopulmonary bypass), 4 hours after end of surgery, 24 hours after end of surgery</time_frame>
    <description>level of Troponin i</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>anesthesia monitoring</measure>
    <time_frame>intraoperative (from anesthetic induction to end of surgery)</time_frame>
    <description>Bispectral index, end tidal sevoflurane</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>fluid management</measure>
    <time_frame>intraoperative (from anesthetic induction to end of surgery)</time_frame>
    <description>amount of transfusion, ROTEM® values</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>fluid management</measure>
    <time_frame>intraoperative (from anesthetic induction to end of surgery)</time_frame>
    <description>blood loss</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">160</enrollment>
  <condition>Congenital Heart Disease</condition>
  <arm_group>
    <arm_group_label>Dexmedetomidine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexmedetomidine</intervention_name>
    <description>continuous infusion of dexmedetomidine during the surgery</description>
    <arm_group_label>Dexmedetomidine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Normal saline</intervention_name>
    <description>continuous infusion of normal saline during the surgery</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Neonates undergoing cardiac surgery&#xD;
&#xD;
          -  Infants undergoing cardiac surgery with cardiopulmonary bypass (atrial septal defect&#xD;
             repair, ventricular septal defect repair, or tetralogy of fallot repair)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of hypersensitivity of any drug&#xD;
&#xD;
          -  Presence of hypotension or bradycardia considering age Bradycardia (heart rate &lt; 80&#xD;
             beats/min) or hypotension (systolic blood pressure &lt; 70mmHg for infants, &lt; 60mmHg for&#xD;
             neonates)&#xD;
&#xD;
          -  Elevated liver enzyme levels (aspartate transaminase &gt;100unit/L, alanine&#xD;
             aminostrasferase &gt; 50 unit/L)&#xD;
&#xD;
          -  surgery with deep hypothermic circulatory arrest&#xD;
&#xD;
          -  Presence of complex cardiac defect&#xD;
&#xD;
          -  single ventricular physiology&#xD;
&#xD;
          -  plan of additional operation within a year&#xD;
&#xD;
          -  preoperative use of beta-agonists&#xD;
&#xD;
          -  presence of history of any neurological disorder&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>1 Year</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Eun-hee Kim</last_name>
    <phone>+82-01-9933-5014</phone>
    <email>beloveun@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Seoul national university hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Eun-hee Kim</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>July 21, 2020</study_first_submitted>
  <study_first_submitted_qc>July 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2020</study_first_posted>
  <last_update_submitted>February 1, 2022</last_update_submitted>
  <last_update_submitted_qc>February 1, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 2, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
    <investigator_full_name>Eun-hee Kim</investigator_full_name>
    <investigator_title>Clinical assistant professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Diseases</mesh_term>
    <mesh_term>Heart Defects, Congenital</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexmedetomidine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04484922
org study id: 2001-062-1095
nct id: NCT04484922
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Neurodevelopmental disability is the most significant complication for survivors of infant
      surgery for congenital heart disease. In this study we sought to determine if intraoperative
      continuous infusion of dexmedetomidine are associated with neurodevelopmental outcomes at 12
      months.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Bayley scales of Infant development
time frame: 1 year after the surgery
description: Developmental outcomes at each assessment and within each domain (cognitive, language, and motor) were classified as "average" if they were within 1 SD of the mean or higher (scores .85), "at risk" if they were 1 to 2 SD below the mean (scores 70-84), and "delayed" if they were .2SD below the mean (,70). The trajectory of development over time in each domain (cognitive, language, and motor)
measure: neurodevelopment biomarker
time frame: intraoperative (before skin incision, end of hypothermia, end of cardiopulmonary bypass), 4 hours after end of surgery
description: plasma glial fibrillary acidic protein concentration
measure: inflammation
time frame: 4 hours after end of surgery
description: level of IL-6
measure: acute kidney injury
time frame: 2 hours after end of cardiopulmonary bypass
description: urinary NGAL
measure: myocardial injury
time frame: intraoperative (before skin incision, end of cardiopulmonary bypass), 4 hours after end of surgery, 24 hours after end of surgery
description: level of Troponin i
measure: anesthesia monitoring
time frame: intraoperative (from anesthetic induction to end of surgery)
description: Bispectral index, end tidal sevoflurane
measure: fluid management
time frame: intraoperative (from anesthetic induction to end of surgery)
description: amount of transfusion, ROTEM® values
measure: fluid management
time frame: intraoperative (from anesthetic induction to end of surgery)
description: blood loss
arm group label: Dexmedetomidine
arm group type: Experimental
arm group label: Control
arm group type: Placebo Comparator
intervention type: Drug
intervention name: Dexmedetomidine
description: continuous infusion of dexmedetomidine during the surgery
arm group label: Dexmedetomidine
intervention type: Drug
intervention name: Normal saline
description: continuous infusion of normal saline during the surgery
arm group label: Control
criteria: 
gender: All
minimum age: N/A
maximum age: 1 Year
healthy volunteers: No
last name: Eun-hee Kim
phone: +82-01-9933-5014
email: beloveun@gmail.com
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Eun-hee Kim
investigator title: Clinical assistant professor
mesh term: Heart Diseases
mesh term: Heart Defects, Congenital
mesh term: Dexmedetomidine
sharing ipd: Undecided