<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/NCT03012997</url>
  </required_header>
  <id_info>
    <org_study_id>KK01</org_study_id>
    <nct_id>NCT03012997</nct_id>
  </id_info>
  <brief_title>Effects of Hyperoxia on Open Heart Surgery</brief_title>
  <official_title>Effects of Hyperoxia on Oxidative Stress in Patients Undergoing Open Heart Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Istanbul University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Koşuyolu Kartal Heart Training and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Istanbul University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients undergoing Open Cardiac Surgery will be randomized into two groups. Group I will be&#xD;
      ventilated with 40% Fio2 during induction, surgery and in Postoperative care unit. Group II&#xD;
      will be ventilated with 100% Fio2 during induction and with 60-70% ( determined according to&#xD;
      the arterial blood gas sample results) during surgery and in Postoperative care unit.&#xD;
&#xD;
      Hemodynamic parameters ( systolic arterial pressure, diastolic arterial pressure, heart rate&#xD;
      ), Arterial blood gas samples ( PaO2, PaCO2, pH, Oxygen saturation, Lactate), and pre and&#xD;
      post cardiopulmonary bypass Superoxide dismutase and malonyl aldehyde levels.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">April 2017</completion_date>
  <primary_completion_date type="Anticipated">April 2017</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>Screening</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>change in Malondialdehyde (MDA) (nmol/mg pr) levels (as a biomarker for oxidative stress ) and Superoxide dismutase (SOD) (nmol/mg pr) levels as a biomarker for antioxidant response in the plasma between &quot;before&quot; and &quot;after&quot; cardiopulmonary bypass</measure>
    <time_frame>72 hours</time_frame>
    <description>As primary outcome, the effects of different inspired oxygen fractions on oxidative stress and anti-oxidant response in before and after cardiopulmonary bypass will be evaluated</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Partial pressure of oxygen(mmHg),</measure>
    <time_frame>72 hours</time_frame>
    <description>Partial pressure of oxygen(mmHg) in arterial-blood-gas samples before induction, following induction, before and after cardiopulmonary bypass, before extubation and following extubation, postoperative 24 and 72th hours.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Partial pressure of carbondioxide(mm Hg)</measure>
    <time_frame>72 hours</time_frame>
    <description>,Partial pressure of carbondioxide(mm Hg) in arterial-blood-gas samples before induction, following induction, before and after cardiopulmonary bypass, before extubation and following extubation, postoperative 24 and 72th hours.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>lactate (mmol/l)</measure>
    <time_frame>72 hours</time_frame>
    <description>lactate (mmol/l) levels in arterial blood gas samples before induction, following induction, before and after cardiopulmonary bypass, before extubation and following extubation, postoperative 24 and 72th hours.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ph values</measure>
    <time_frame>72 hours</time_frame>
    <description>ph values in arterial blood gas samples before induction, following induction, before and after cardiopulmonary bypass, before extubation and following extubation, postoperative 24 and 72th hours.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>systolic arterial pressure (mmHg),</measure>
    <time_frame>72 hours</time_frame>
    <description>systolic arterial pressure (mmHg), levels before induction, following induction, before and after cardiopulmonary bypass, before extubation and following extubation, postoperative 24 and 72th hours.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>diastolic arterial pressure (mmHg)</measure>
    <time_frame>72 hours</time_frame>
    <description>diastolic arterial pressure (mmHg) levels before induction, following induction, before and after cardiopulmonary bypass, before extubation and following extubation, postoperative 24 and 72th hours.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oxygen saturation (%)</measure>
    <time_frame>72 hours</time_frame>
    <description>Oxygen saturation (%) levels in arterial blood gas samples before induction, following induction, before and after cardiopulmonary bypass, before extubation and following extubation, postoperative 24 and 72th hours.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>heart rate (beat/min)</measure>
    <time_frame>72 hours</time_frame>
    <description>heart rate (beat/min) levels before induction, following induction, before and after cardiopulmonary bypass, before extubation and following extubation, postoperative 24 and 72th hours.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Heart Valve Disease</condition>
  <condition>Coronary (Artery) Disease</condition>
  <arm_group>
    <arm_group_label>Active Comparator: 40% oxygen</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients in this group will be ventilated with fraction of inspired oxygen 40% during the induction, surgery and in Postoperative care unit.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Active Comparator: 100% oxygen</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients in this group will be ventilated with fraction of inspired oxygen during 100% induction and with 60-70% ( determined according to the arterial blood gas sample results) during surgery and in Postoperative care unit.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Fraction of inspired oxygen 40%</intervention_name>
    <arm_group_label>Active Comparator: 40% oxygen</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Fraction of inspired oxygen 100%</intervention_name>
    <arm_group_label>Active Comparator: 100% oxygen</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ASA II-III&#xD;
&#xD;
          -  Patients with EF higher than 50%.&#xD;
&#xD;
          -  patients undergoing elective open heart surgery on pump ( CABG, Valve Replacement)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients with Diabetes Mellitus&#xD;
&#xD;
          -  patients with COPD&#xD;
&#xD;
          -  Patients with Cerebral Vascular Disease&#xD;
&#xD;
          -  Patients with hypoxia in Arterial blood gas samples ( PaO2 lower than 80 mmHg) and&#xD;
             hypercarbia (PaCO2 higher than 45 mmHg)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Guniz Koksal, Professor</last_name>
    <role>Study Director</role>
    <affiliation>Istanbul University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Guniz Koksal, Professor</last_name>
    <phone>05322067777</phone>
    <email>gunizkoksal@hotmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Kartal Kosuyolu Training and Research Hospital</name>
      <address>
        <city>Istanbul</city>
        <state>Marmara</state>
        <zip>35000</zip>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Kartal Kosuyolu Training and Research Hospital</name>
      <address>
        <city>Istanbul</city>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>emre gurcu, Specialist</last_name>
      <phone>905058917800</phone>
      <email>emregurcu@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>Koksal GM, Dikmen Y, Erbabacan E, Aydin S, Cakatay U, Sitar ME, Altindas F. Hyperoxic oxidative stress during abdominal surgery: a randomized trial. J Anesth. 2016 Aug;30(4):610-9. doi: 10.1007/s00540-016-2164-7. Epub 2016 Mar 21.</citation>
    <PMID>27001081</PMID>
  </reference>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>December 9, 2016</study_first_submitted>
  <study_first_submitted_qc>January 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 6, 2017</study_first_posted>
  <last_update_submitted>January 5, 2017</last_update_submitted>
  <last_update_submitted_qc>January 5, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Istanbul University</investigator_affiliation>
    <investigator_full_name>Guniz M.Koksal</investigator_full_name>
    <investigator_title>Professor Anesthesiologist</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Valve Diseases</mesh_term>
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Coronary Disease</mesh_term>
    <mesh_term>Hyperoxia</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/NCT03012997
org study id: KK01
nct id: NCT03012997
lead sponsor: 
collaborator: 
has dmc: No
Patients undergoing Open Cardiac Surgery will be randomized into two groups. Group I will be
      ventilated with 40% Fio2 during induction, surgery and in Postoperative care unit. Group II
      will be ventilated with 100% Fio2 during induction and with 60-70% ( determined according to
      the arterial blood gas sample results) during surgery and in Postoperative care unit.

      Hemodynamic parameters ( systolic arterial pressure, diastolic arterial pressure, heart rate
      ), Arterial blood gas samples ( PaO2, PaCO2, pH, Oxygen saturation, Lactate), and pre and
      post cardiopulmonary bypass Superoxide dismutase and malonyl aldehyde levels.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Screening
masking: Double (Participant, Outcomes Assessor)
measure: change in Malondialdehyde (MDA) (nmol/mg pr) levels (as a biomarker for oxidative stress ) and Superoxide dismutase (SOD) (nmol/mg pr) levels as a biomarker for antioxidant response in the plasma between "before" and "after" cardiopulmonary bypass
time frame: 72 hours
description: As primary outcome, the effects of different inspired oxygen fractions on oxidative stress and anti-oxidant response in before and after cardiopulmonary bypass will be evaluated
measure: Partial pressure of oxygen(mmHg),
time frame: 72 hours
description: Partial pressure of oxygen(mmHg) in arterial-blood-gas samples before induction, following induction, before and after cardiopulmonary bypass, before extubation and following extubation, postoperative 24 and 72th hours.
measure: Partial pressure of carbondioxide(mm Hg)
time frame: 72 hours
description: ,Partial pressure of carbondioxide(mm Hg) in arterial-blood-gas samples before induction, following induction, before and after cardiopulmonary bypass, before extubation and following extubation, postoperative 24 and 72th hours.
measure: lactate (mmol/l)
time frame: 72 hours
description: lactate (mmol/l) levels in arterial blood gas samples before induction, following induction, before and after cardiopulmonary bypass, before extubation and following extubation, postoperative 24 and 72th hours.
measure: ph values
time frame: 72 hours
description: ph values in arterial blood gas samples before induction, following induction, before and after cardiopulmonary bypass, before extubation and following extubation, postoperative 24 and 72th hours.
measure: systolic arterial pressure (mmHg),
time frame: 72 hours
description: systolic arterial pressure (mmHg), levels before induction, following induction, before and after cardiopulmonary bypass, before extubation and following extubation, postoperative 24 and 72th hours.
measure: diastolic arterial pressure (mmHg)
time frame: 72 hours
description: diastolic arterial pressure (mmHg) levels before induction, following induction, before and after cardiopulmonary bypass, before extubation and following extubation, postoperative 24 and 72th hours.
measure: Oxygen saturation (%)
time frame: 72 hours
description: Oxygen saturation (%) levels in arterial blood gas samples before induction, following induction, before and after cardiopulmonary bypass, before extubation and following extubation, postoperative 24 and 72th hours.
measure: heart rate (beat/min)
time frame: 72 hours
description: heart rate (beat/min) levels before induction, following induction, before and after cardiopulmonary bypass, before extubation and following extubation, postoperative 24 and 72th hours.
arm group label: Active Comparator: 40% oxygen
arm group type: Active Comparator
description: Patients in this group will be ventilated with fraction of inspired oxygen 40% during the induction, surgery and in Postoperative care unit.
arm group label: Active Comparator: 100% oxygen
arm group type: Active Comparator
description: Patients in this group will be ventilated with fraction of inspired oxygen during 100% induction and with 60-70% ( determined according to the arterial blood gas sample results) during surgery and in Postoperative care unit.
intervention type: Other
intervention name: Fraction of inspired oxygen 40%
arm group label: Active Comparator: 40% oxygen
intervention type: Other
intervention name: Fraction of inspired oxygen 100%
arm group label: Active Comparator: 100% oxygen
criteria: 
gender: All
minimum age: 20 Years
maximum age: 65 Years
healthy volunteers: No
last name: Guniz Koksal, Professor
role: Study Director
affiliation: Istanbul University
last name: Guniz Koksal, Professor
phone: 05322067777
email: gunizkoksal@hotmail.com
facility: 
status: Recruiting
facility: 
status: Recruiting
contact: 
country: Turkey
citation: Koksal GM, Dikmen Y, Erbabacan E, Aydin S, Cakatay U, Sitar ME, Altindas F. Hyperoxic oxidative stress during abdominal surgery: a randomized trial. J Anesth. 2016 Aug;30(4):610-9. doi: 10.1007/s00540-016-2164-7. Epub 2016 Mar 21.
PMID: 27001081
responsible party type: Principal Investigator
investigator affiliation: Istanbul University
investigator full name: Guniz M.Koksal
investigator title: Professor Anesthesiologist
mesh term: Heart Valve Diseases
mesh term: Coronary Artery Disease
mesh term: Coronary Disease
mesh term: Hyperoxia