<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/NCT01685554</url>
  </required_header>
  <id_info>
    <org_study_id>Norm-Arh-2012</org_study_id>
    <nct_id>NCT01685554</nct_id>
  </id_info>
  <brief_title>Normothermiс Cardiopulmonary Bypass Increases Cerebral Oxygenation During Valve Surgery</brief_title>
  <official_title>Normothermiс Cardiopulmonary Bypass Increases Cerebral Oxygenation During Combined Valve Surgery: Single Center, Randomized Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northern State Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Northern State Medical University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of our study was to evaluate the effect of different temperature regimens of&#xD;
      cardiopulmonary bypass on systemic oxygen transport and cerebral oxygenation during surgical&#xD;
      correction of acquired heart diseases.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Our aim was to evaluate the effect of hypothermic and normothermic regimens of&#xD;
      cardiopulmonary bypass on systemic oxygen transport and cerebral oxygenation during valve&#xD;
      surgery&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2010</start_date>
  <completion_date type="Actual">December 2011</completion_date>
  <primary_completion_date type="Actual">December 2011</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>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cerebral oxygen saturation</measure>
    <time_frame>perioperatively</time_frame>
    <description>measurement of cerebral oxygen saturation during cardiopulmonary bypass and 24 hrs postoperatively</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>time until &quot;fit for ICU discharge&quot; fulfillment</measure>
    <time_frame>5 days postoperatively</time_frame>
    <description>measurement of time to fulfillment of the &quot;fit for discharge&quot; criteria</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Heart Valve Diseases</condition>
  <arm_group>
    <arm_group_label>normothermic CPB</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>cardiopulmonary bypass with maintenance of normal body temperature</description>
  </arm_group>
  <arm_group>
    <arm_group_label>hypothermic CPB</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>cardiopulmonary bypass using mild hypothermia</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>hypothermic CPB</intervention_name>
    <description>maintenance of mild hypothermia during cardiopulmonary bypass</description>
    <arm_group_label>hypothermic CPB</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>normothermic CPB</intervention_name>
    <description>maintenance of normal body temperature during cardiopulmonary bypass</description>
    <arm_group_label>normothermic CPB</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  requirement of surgical correction of two or more valves&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mikhail Y Kirov, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Northern State Medical Univercity</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dep. of Anesthesiology, Northern SMU</name>
      <address>
        <city>Arkhangelsk</city>
        <zip>163000</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Russian Federation</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>September 4, 2012</study_first_submitted>
  <study_first_submitted_qc>September 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 14, 2012</study_first_posted>
  <last_update_submitted>October 17, 2012</last_update_submitted>
  <last_update_submitted_qc>October 17, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 18, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>perfusion</keyword>
  <keyword>cardiopulmonary bypass</keyword>
  <keyword>hypothermia</keyword>
  <keyword>cerebral oxygenation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Valve Diseases</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/NCT01685554
org study id: Norm-Arh-2012
nct id: NCT01685554
lead sponsor: 
has dmc: No
The aim of our study was to evaluate the effect of different temperature regimens of
      cardiopulmonary bypass on systemic oxygen transport and cerebral oxygenation during surgical
      correction of acquired heart diseases.
Our aim was to evaluate the effect of hypothermic and normothermic regimens of
      cardiopulmonary bypass on systemic oxygen transport and cerebral oxygenation during valve
      surgery
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Cerebral oxygen saturation
time frame: perioperatively
description: measurement of cerebral oxygen saturation during cardiopulmonary bypass and 24 hrs postoperatively
measure: time until "fit for ICU discharge" fulfillment
time frame: 5 days postoperatively
description: measurement of time to fulfillment of the "fit for discharge" criteria
arm group label: normothermic CPB
arm group type: Active Comparator
description: cardiopulmonary bypass with maintenance of normal body temperature
arm group label: hypothermic CPB
arm group type: Active Comparator
description: cardiopulmonary bypass using mild hypothermia
intervention type: Device
intervention name: hypothermic CPB
description: maintenance of mild hypothermia during cardiopulmonary bypass
arm group label: hypothermic CPB
intervention type: Device
intervention name: normothermic CPB
description: maintenance of normal body temperature during cardiopulmonary bypass
arm group label: normothermic CPB
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Mikhail Y Kirov, MD, PhD
role: Study Director
affiliation: Northern State Medical Univercity
facility: 
country: Russian Federation
responsible party type: Sponsor
mesh term: Heart Valve Diseases