<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/NCT03006484</url>
  </required_header>
  <id_info>
    <org_study_id>2016-1378</org_study_id>
    <nct_id>NCT03006484</nct_id>
  </id_info>
  <brief_title>Neurological Outcomes After In-Hospital Cardiac Arrest</brief_title>
  <acronym>NO-IHCA</acronym>
  <official_title>Neurological Outcomes After In-hospital Cardiac Arrest: a Prospective Observational Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Asan Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Asan Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Little is known about the long-term neurological outcomes after in-hospital cardiac arrest&#xD;
      (IHCA). It is also not known whether withdrawal of life-sustaining measures will influence&#xD;
      rates of survivors with poor neurological status. Currently, withdrawal of care in comatose&#xD;
      patients after cardiac arrest is strongly forbidden by law in Korea. However, a new&#xD;
      legislation on allowing withdrawal of care will come into effect since early 2018 in Korea.&#xD;
      The investigators aim to determine 1) long-term neurological outcomes in patients who&#xD;
      developed IHCA, 2) whether early neurological status can predict late neurological status&#xD;
      after IHCA, and 3) whether the proportion of IHCA survivors with good neurological outcomes&#xD;
      will change since implementation of new legislation on withdrawal of care.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      &lt;The schedule of assessment&gt;&#xD;
&#xD;
        -  Day 0: Neurological examination (First examination will be performed within 2 hours&#xD;
           after IHCA)&#xD;
&#xD;
        -  Day1 - 7: Neurological examination&#xD;
&#xD;
        -  Day7, 14, 21, 28: Neurological examination, CPC score&#xD;
&#xD;
        -  Day90: CPC score, survival&#xD;
&#xD;
        -  Day180: CPC score, survival&#xD;
&#xD;
        -  Day 360: CPC score, survival&#xD;
&#xD;
      &lt;Cerebral Performance Category(CPC) score&gt;&#xD;
&#xD;
        -  CPC 1: good cerebral performance&#xD;
&#xD;
        -  CPC 2: Moderate cerebral disability(available for independent activities)&#xD;
&#xD;
        -  CPC 3: Severe cerebral disability(dependent on others for daily support)&#xD;
&#xD;
        -  CPC 4: Coma or vegetative state&#xD;
&#xD;
        -  CPC 5: Brain death or death&#xD;
&#xD;
      &lt;Acronyms&gt;&#xD;
&#xD;
        -  ACDU(Alert/Confused/Drowsy/Unresponsive) score&#xD;
&#xD;
        -  FOUR(Full Outline of Unresponsiveness) score&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 21, 2017</start_date>
  <completion_date type="Actual">February 3, 2020</completion_date>
  <primary_completion_date type="Actual">February 3, 2020</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>Cerebral Performance Category(CPC) score of 1-2</measure>
    <time_frame>12 month after In-Hospital Cardiac Arrest(IHCA)</time_frame>
    <description>CPC score is the most universal index to assess neurological outcome following cardiac arrest. CPC score is classified according to the point. Good neurological outcome is defined as CPC 1-2 and poor is CPC 3-5.&#xD;
CPC score will be evaluated by neurological examination and the results of other exam.&#xD;
Neurological examination: Neurologist will perform directly until the point of CPC score 1 is confirmed.&#xD;
mental status: ACDU score, FOUR score and Glasgow Coma Scale&#xD;
brain stem reflex: Light reflexes by pupillometer(the NeurOptics® NPi™-100 (Neuroptics Inc., Irvine, CA, USA)) and corneal reflexes&#xD;
motor status&#xD;
Responsive state: Medical Research Council grade&#xD;
Unresponsive state: motor response to painful stimuli)&#xD;
seizure evaluation: status myoclonus , seizure, status epilepticus&#xD;
The result of other examinations in accordance with medical treatment guideline will be evaluated as well. (e.g. Finding MRI of the brain, EEG, neuron specific enolase)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>CPC score</measure>
    <time_frame>Day 7, day 14, day 21, day 28, 3 month, 6 month, and 12 month after IHCA</time_frame>
    <description>CPC score is the most universal index to assess neurological outcome following cardiac arrest. CPC score is classified according to the point. Good neurological outcome is defined as CPC 1-2 and poor is CPC 3-5.&#xD;
CPC score will be evaluated by neurological examination and the results of other exam.&#xD;
Neurological examination: Neurologist will perform directly until the point of CPC score 1 is confirmed.&#xD;
mental status: ACDU score, FOUR score and Glasgow Coma Scale&#xD;
brain stem reflex: Light reflexes by pupillometer(the NeurOptics® NPi™-100 (Neuroptics Inc., Irvine, CA, USA)) and corneal reflexes&#xD;
motor status&#xD;
Responsive state: Medical Research Council grade&#xD;
Unresponsive state: motor response to painful stimuli)&#xD;
seizure evaluation: status myoclonus , seizure, status epilepticus&#xD;
The result of other examinations in accordance with medical treatment guideline will be evaluated as well. (e.g. Finding MRI of the brain, EEG, neuron specific enolase)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>Day 0-28, 3 month, 6 month, and 12 month after IHCA</time_frame>
    <description>A measure of the number of deaths in a particular population</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Awakening</measure>
    <time_frame>Day 0-28 after IHCA</time_frame>
    <description>Following commands</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neurological recovery</measure>
    <time_frame>Day 0-28 after IHCA</time_frame>
    <description>CPC of 1</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">322</enrollment>
  <condition>Inhospital Cardiac Arrest</condition>
  <arm_group>
    <arm_group_label>Before Period</arm_group_label>
    <description>Patients who developed in-hosptial cardiac arrest before the implementation of new legislation on life-sustaining treatments</description>
  </arm_group>
  <arm_group>
    <arm_group_label>After Period</arm_group_label>
    <description>Patients who developed in-hosptial cardiac arrest after the implementation of new legislation on life-sustaining treatments</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No intervention</intervention_name>
    <description>No intervention will be needed.</description>
    <arm_group_label>After Period</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The patient who experienced In-hospital cardiac arrest(IHCA) in Asan Medical Center.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18&#xD;
&#xD;
          -  In-hospital cardiac arrest&#xD;
&#xD;
          -  Cardiopulmonary Resuscitation(CPR) code activation and/or neurology consultation for&#xD;
             IHCA&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Neither (CPR) code activation nor neurology consultation&#xD;
&#xD;
          -  Development of IHCA during transition period&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sang-Beom Jeon, Master</last_name>
    <role>Principal Investigator</role>
    <affiliation>Asan Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Asan Medical Center</name>
      <address>
        <city>Seoul</city>
        <state>Songpa-gu</state>
        <zip>05505</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>December 26, 2016</study_first_submitted>
  <study_first_submitted_qc>December 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 30, 2016</study_first_posted>
  <last_update_submitted>May 12, 2020</last_update_submitted>
  <last_update_submitted_qc>May 12, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Asan Medical Center</investigator_affiliation>
    <investigator_full_name>Sang-Beom Jeon</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Cardiac arrest</keyword>
  <keyword>Inhospital Cardiac Arrest</keyword>
  <keyword>Cardiopulmonary Resuscitation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Arrest</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03006484
org study id: 2016-1378
nct id: NCT03006484
lead sponsor: 
has dmc: No
Little is known about the long-term neurological outcomes after in-hospital cardiac arrest
      (IHCA). It is also not known whether withdrawal of life-sustaining measures will influence
      rates of survivors with poor neurological status. Currently, withdrawal of care in comatose
      patients after cardiac arrest is strongly forbidden by law in Korea. However, a new
      legislation on allowing withdrawal of care will come into effect since early 2018 in Korea.
      The investigators aim to determine 1) long-term neurological outcomes in patients who
      developed IHCA, 2) whether early neurological status can predict late neurological status
      after IHCA, and 3) whether the proportion of IHCA survivors with good neurological outcomes
      will change since implementation of new legislation on withdrawal of care.
<The schedule of assessment>

        -  Day 0: Neurological examination (First examination will be performed within 2 hours
           after IHCA)

        -  Day1 - 7: Neurological examination

        -  Day7, 14, 21, 28: Neurological examination, CPC score

        -  Day90: CPC score, survival

        -  Day180: CPC score, survival

        -  Day 360: CPC score, survival

      <Cerebral Performance Category(CPC) score>

        -  CPC 1: good cerebral performance

        -  CPC 2: Moderate cerebral disability(available for independent activities)

        -  CPC 3: Severe cerebral disability(dependent on others for daily support)

        -  CPC 4: Coma or vegetative state

        -  CPC 5: Brain death or death

      <Acronyms>

        -  ACDU(Alert/Confused/Drowsy/Unresponsive) score

        -  FOUR(Full Outline of Unresponsiveness) score
observational model: Cohort
time perspective: Prospective
measure: Cerebral Performance Category(CPC) score of 1-2
time frame: 12 month after In-Hospital Cardiac Arrest(IHCA)
description: CPC score is the most universal index to assess neurological outcome following cardiac arrest. CPC score is classified according to the point. Good neurological outcome is defined as CPC 1-2 and poor is CPC 3-5.
CPC score will be evaluated by neurological examination and the results of other exam.
Neurological examination: Neurologist will perform directly until the point of CPC score 1 is confirmed.
mental status: ACDU score, FOUR score and Glasgow Coma Scale
brain stem reflex: Light reflexes by pupillometer(the NeurOptics® NPi™-100 (Neuroptics Inc., Irvine, CA, USA)) and corneal reflexes
motor status
Responsive state: Medical Research Council grade
Unresponsive state: motor response to painful stimuli)
seizure evaluation: status myoclonus , seizure, status epilepticus
The result of other examinations in accordance with medical treatment guideline will be evaluated as well. (e.g. Finding MRI of the brain, EEG, neuron specific enolase)
measure: CPC score
time frame: Day 7, day 14, day 21, day 28, 3 month, 6 month, and 12 month after IHCA
description: CPC score is the most universal index to assess neurological outcome following cardiac arrest. CPC score is classified according to the point. Good neurological outcome is defined as CPC 1-2 and poor is CPC 3-5.
CPC score will be evaluated by neurological examination and the results of other exam.
Neurological examination: Neurologist will perform directly until the point of CPC score 1 is confirmed.
mental status: ACDU score, FOUR score and Glasgow Coma Scale
brain stem reflex: Light reflexes by pupillometer(the NeurOptics® NPi™-100 (Neuroptics Inc., Irvine, CA, USA)) and corneal reflexes
motor status
Responsive state: Medical Research Council grade
Unresponsive state: motor response to painful stimuli)
seizure evaluation: status myoclonus , seizure, status epilepticus
The result of other examinations in accordance with medical treatment guideline will be evaluated as well. (e.g. Finding MRI of the brain, EEG, neuron specific enolase)
measure: Mortality
time frame: Day 0-28, 3 month, 6 month, and 12 month after IHCA
description: A measure of the number of deaths in a particular population
measure: Awakening
time frame: Day 0-28 after IHCA
description: Following commands
measure: Neurological recovery
time frame: Day 0-28 after IHCA
description: CPC of 1
arm group label: Before Period
description: Patients who developed in-hosptial cardiac arrest before the implementation of new legislation on life-sustaining treatments
arm group label: After Period
description: Patients who developed in-hosptial cardiac arrest after the implementation of new legislation on life-sustaining treatments
intervention type: Other
intervention name: No intervention
description: No intervention will be needed.
arm group label: After Period
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sang-Beom Jeon, Master
role: Principal Investigator
affiliation: Asan Medical Center
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Asan Medical Center
investigator full name: Sang-Beom Jeon
investigator title: Associate Professor
mesh term: Heart Arrest
sharing ipd: No