<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/NCT03024021</url>
  </required_header>
  <id_info>
    <org_study_id>29/3</org_study_id>
    <nct_id>NCT03024021</nct_id>
  </id_info>
  <brief_title>Cerebral Oxymetry and Neurological Outcome in Therapeutic Hypothermia</brief_title>
  <official_title>The Effect of Cerebral Oxymetry in Determining Neurological Outcome in Patients Treated With Therapeutic Hypothermia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tepecik Training and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tepecik Training and Research Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is designed to assess the effect of cerebral oxygen saturation as an early&#xD;
      predictor of neurological outcomes in patients undergoing therapeutic hypothermia after&#xD;
      cardiac arrest&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Our study is planned as a prospective observational study. Patients undergoing therapeutic&#xD;
      hypothermia in our intensive care unit after cardiac arrest will be enrolled. Each patient's&#xD;
      cerebral oxygenation will be monitored with near-infrared spectroscopy (NIRS) in every 6&#xD;
      hours during our 24 hour lasting hypothermia period. Afterwards, patients will be monitorised&#xD;
      in every 6 hours during the first day of hypothermia and than the mean values of daily&#xD;
      cerebral oxygen values will be noted in the third, fourth and fifth days of nomothermia.&#xD;
      Regional oxygen saturation (rSO2) will be noted from left and right probes. Full Outline of&#xD;
      Unresponsiveness (FOUR) Score, Glasgow Coma Score (GCS) and cerebral performance category&#xD;
      scale (CPC) will be noted at the beginning of therapeutic hypothermia and each day during&#xD;
      normothermia, day 21 and the day of discharge from ICU.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2016</start_date>
  <completion_date type="Actual">December 2018</completion_date>
  <primary_completion_date type="Actual">September 2018</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>Measure of cerebral oximetry</measure>
    <time_frame>8 times during the first 48 hours of hospitalization</time_frame>
    <description>During the first 48 hours of hospitalization, we will collect the cerebral oximetry values in the two cerebral. hemispheres.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The cerebral oximetry values (average of the two hemispheres) will be compared between patients with good and poor neurological outcome according with CPC score</measure>
    <time_frame>Participants will be followed for 8 times during the first 48 hours of hospitalization, the third day, fourth day and fifth day and the duration of hospital stay, an expected average of 2-4 weeks and a 12 month follow up will be performed</time_frame>
    <description>The cerebral oximetry values (average of the two hemispheres) will be compared between patients with good and poor neurological outcome according to the CPC score.&#xD;
CPC 1: Conscious and alert with normal function or only slight disability CPC 2: Conscious and alert with moderate disability CPC 3: Conscious with severe disability CPC 4: Comatose or persistent vegetative state CPC 5: death. CPC will be evaluated at the time of admission to intensive care unit and day 21.CPC score (CPC = 1 become good score - 2 and bad become CPC = 3-5).</description>
  </secondary_outcome>
  <other_outcome>
    <measure>The cerebral oximetry values (average of the two hemispheres) will be compared between patients with good and poor neurological outcome according with Four score</measure>
    <time_frame>Participants will be followed for 8 times during the first 48 hours of hospitalization, the third day, fourth day and fifth day and the duration of hospital stay, an expected average of 2-4 weeks and a 12 month follow up will be performed</time_frame>
    <description>The cerebral oximetry values (average of the two hemispheres) will be compared between patients with good and poor neurological outcome according to the Fourscore (Full Outline of UnResponsiveness):It evaluates four functional categories: eye response, motor response, brainstem reflexes, and respiration pattern (including mechanical ventilation). All the four categories are scored from 0 to 4 points, with 4 representing normal, and 0 indicating no function.</description>
  </other_outcome>
  <enrollment type="Actual">100</enrollment>
  <condition>Hypoxic-Ischemic Encephalopathy</condition>
  <condition>Post-Cardiorespiratory Arrest Coma</condition>
  <condition>Cardiac Arrest</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Near-infrared spectroscopy (NIRS) (INVOS®, Covidien)</intervention_name>
    <description>As we start the targeted temperature management protocol (24 hours of hypothermia adjusted to 33-36 C and afterwards up to five days of normothermia [36.5 C]) NIRS sensor pads will be placed over the right and left frontal area. Regional cerebral oxygen values will be continuously recorded at the NIRS monitor. Tests to assess neurological outcome will be performed. Patients will be assessed in terms of neurological performance tests and regional cerebral oxygen.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients undergoing therapeutic hypothermia after cardiac arrest in a tertiary intensive&#xD;
        care unit&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients at least 18 years old&#xD;
&#xD;
          -  Patients undergoing therapeutic hypothermia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients under 18 years&#xD;
&#xD;
          -  Patients unsuitable for therapeutic hypothermia&#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>Aykut Saritas</last_name>
    <role>Study Director</role>
    <affiliation>Tepecik Research and Training Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Burcu Acar Cinleti</last_name>
    <role>Study Chair</role>
    <affiliation>suat seren research and training hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ciler Zincircioglu</last_name>
    <role>Study Chair</role>
    <affiliation>Tepecik Research and Training Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>İsil Kose</last_name>
    <role>Study Chair</role>
    <affiliation>Tepecik Research and Training Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ugur Uzun</last_name>
    <role>Study Chair</role>
    <affiliation>Tepecik Research and Training Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Nimet Senoglu</last_name>
    <role>Study Chair</role>
    <affiliation>Tepecik Research and Training Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Tepecik Research and Training Hospital</name>
      <address>
        <city>Izmir</city>
        <state>Konak</state>
        <zip>35110</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>Storm C, Leithner C, Krannich A, Wutzler A, Ploner CJ, Trenkmann L, von Rheinbarben S, Schroeder T, Luckenbach F, Nee J. Regional cerebral oxygen saturation after cardiac arrest in 60 patients--a prospective outcome study. Resuscitation. 2014 Aug;85(8):1037-41. doi: 10.1016/j.resuscitation.2014.04.021. Epub 2014 Apr 30.</citation>
    <PMID>24795284</PMID>
  </reference>
  <results_reference>
    <citation>Genbrugge C, Eertmans W, Meex I, Van Kerrebroeck M, Daems N, Creemers A, Jans F, Boer W, Dens J, De Deyne C. What is the value of regional cerebral saturation in post-cardiac arrest patients? A prospective observational study. Crit Care. 2016 Oct 13;20(1):327. doi: 10.1186/s13054-016-1509-9.</citation>
    <PMID>27733184</PMID>
  </results_reference>
  <results_reference>
    <citation>Nishiyama K, Ito N, Orita T, Hayashida K, Arimoto H, Beppu S, Abe M, Unoki T, Endo T, Murai A, Hatada T, Yamada N, Mizobuchi M, Himeno H, Okuchi K, Yasuda H, Mochizuki T, Shiga K, Kikuchi M, Tsujimura Y, Hatanaka T, Nagao K; J-POP Registry Investigators. Regional cerebral oxygen saturation monitoring for predicting interventional outcomes in patients following out-of-hospital cardiac arrest of presumed cardiac cause: A prospective, observational, multicentre study. Resuscitation. 2015 Nov;96:135-41. doi: 10.1016/j.resuscitation.2015.07.049. Epub 2015 Aug 17.</citation>
    <PMID>26291387</PMID>
  </results_reference>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>December 21, 2016</study_first_submitted>
  <study_first_submitted_qc>January 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 18, 2017</study_first_posted>
  <last_update_submitted>March 9, 2020</last_update_submitted>
  <last_update_submitted_qc>March 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tepecik Training and Research Hospital</investigator_affiliation>
    <investigator_full_name>Aykut Saritas</investigator_full_name>
    <investigator_title>principal investigator</investigator_title>
  </responsible_party>
  <keyword>therapeutic hypothermia</keyword>
  <keyword>targeted temperature management</keyword>
  <keyword>neurological outcome</keyword>
  <keyword>post-cardiac arrest syndrome</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Diseases</mesh_term>
    <mesh_term>Brain Ischemia</mesh_term>
    <mesh_term>Hypoxia-Ischemia, Brain</mesh_term>
    <mesh_term>Heart Arrest</mesh_term>
    <mesh_term>Hypothermia</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/NCT03024021
org study id: 29/3
nct id: NCT03024021
lead sponsor: 
has dmc: No
This study is designed to assess the effect of cerebral oxygen saturation as an early
      predictor of neurological outcomes in patients undergoing therapeutic hypothermia after
      cardiac arrest
Our study is planned as a prospective observational study. Patients undergoing therapeutic
      hypothermia in our intensive care unit after cardiac arrest will be enrolled. Each patient's
      cerebral oxygenation will be monitored with near-infrared spectroscopy (NIRS) in every 6
      hours during our 24 hour lasting hypothermia period. Afterwards, patients will be monitorised
      in every 6 hours during the first day of hypothermia and than the mean values of daily
      cerebral oxygen values will be noted in the third, fourth and fifth days of nomothermia.
      Regional oxygen saturation (rSO2) will be noted from left and right probes. Full Outline of
      Unresponsiveness (FOUR) Score, Glasgow Coma Score (GCS) and cerebral performance category
      scale (CPC) will be noted at the beginning of therapeutic hypothermia and each day during
      normothermia, day 21 and the day of discharge from ICU.
observational model: Cohort
time perspective: Prospective
measure: Measure of cerebral oximetry
time frame: 8 times during the first 48 hours of hospitalization
description: During the first 48 hours of hospitalization, we will collect the cerebral oximetry values in the two cerebral. hemispheres.
measure: The cerebral oximetry values (average of the two hemispheres) will be compared between patients with good and poor neurological outcome according with CPC score
time frame: Participants will be followed for 8 times during the first 48 hours of hospitalization, the third day, fourth day and fifth day and the duration of hospital stay, an expected average of 2-4 weeks and a 12 month follow up will be performed
description: The cerebral oximetry values (average of the two hemispheres) will be compared between patients with good and poor neurological outcome according to the CPC score.
CPC 1: Conscious and alert with normal function or only slight disability CPC 2: Conscious and alert with moderate disability CPC 3: Conscious with severe disability CPC 4: Comatose or persistent vegetative state CPC 5: death. CPC will be evaluated at the time of admission to intensive care unit and day 21.CPC score (CPC = 1 become good score - 2 and bad become CPC = 3-5).
measure: The cerebral oximetry values (average of the two hemispheres) will be compared between patients with good and poor neurological outcome according with Four score
time frame: Participants will be followed for 8 times during the first 48 hours of hospitalization, the third day, fourth day and fifth day and the duration of hospital stay, an expected average of 2-4 weeks and a 12 month follow up will be performed
description: The cerebral oximetry values (average of the two hemispheres) will be compared between patients with good and poor neurological outcome according to the Fourscore (Full Outline of UnResponsiveness):It evaluates four functional categories: eye response, motor response, brainstem reflexes, and respiration pattern (including mechanical ventilation). All the four categories are scored from 0 to 4 points, with 4 representing normal, and 0 indicating no function.
intervention type: Device
intervention name: Near-infrared spectroscopy (NIRS) (INVOS®, Covidien)
description: As we start the targeted temperature management protocol (24 hours of hypothermia adjusted to 33-36 C and afterwards up to five days of normothermia [36.5 C]) NIRS sensor pads will be placed over the right and left frontal area. Regional cerebral oxygen values will be continuously recorded at the NIRS monitor. Tests to assess neurological outcome will be performed. Patients will be assessed in terms of neurological performance tests and regional cerebral oxygen.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Aykut Saritas
role: Study Director
affiliation: Tepecik Research and Training Hospital
last name: Burcu Acar Cinleti
role: Study Chair
affiliation: suat seren research and training hospital
last name: Ciler Zincircioglu
role: Study Chair
affiliation: Tepecik Research and Training Hospital
last name: İsil Kose
role: Study Chair
affiliation: Tepecik Research and Training Hospital
last name: Ugur Uzun
role: Study Chair
affiliation: Tepecik Research and Training Hospital
last name: Nimet Senoglu
role: Study Chair
affiliation: Tepecik Research and Training Hospital
facility: 
country: Turkey
citation: Storm C, Leithner C, Krannich A, Wutzler A, Ploner CJ, Trenkmann L, von Rheinbarben S, Schroeder T, Luckenbach F, Nee J. Regional cerebral oxygen saturation after cardiac arrest in 60 patients--a prospective outcome study. Resuscitation. 2014 Aug;85(8):1037-41. doi: 10.1016/j.resuscitation.2014.04.021. Epub 2014 Apr 30.
PMID: 24795284
citation: Genbrugge C, Eertmans W, Meex I, Van Kerrebroeck M, Daems N, Creemers A, Jans F, Boer W, Dens J, De Deyne C. What is the value of regional cerebral saturation in post-cardiac arrest patients? A prospective observational study. Crit Care. 2016 Oct 13;20(1):327. doi: 10.1186/s13054-016-1509-9.
PMID: 27733184
citation: Nishiyama K, Ito N, Orita T, Hayashida K, Arimoto H, Beppu S, Abe M, Unoki T, Endo T, Murai A, Hatada T, Yamada N, Mizobuchi M, Himeno H, Okuchi K, Yasuda H, Mochizuki T, Shiga K, Kikuchi M, Tsujimura Y, Hatanaka T, Nagao K; J-POP Registry Investigators. Regional cerebral oxygen saturation monitoring for predicting interventional outcomes in patients following out-of-hospital cardiac arrest of presumed cardiac cause: A prospective, observational, multicentre study. Resuscitation. 2015 Nov;96:135-41. doi: 10.1016/j.resuscitation.2015.07.049. Epub 2015 Aug 17.
PMID: 26291387
responsible party type: Principal Investigator
investigator affiliation: Tepecik Training and Research Hospital
investigator full name: Aykut Saritas
investigator title: principal investigator
mesh term: Brain Diseases
mesh term: Brain Ischemia
mesh term: Hypoxia-Ischemia, Brain
mesh term: Heart Arrest
mesh term: Hypothermia