<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/NCT02979275</url>
  </required_header>
  <id_info>
    <org_study_id>NKEBN/122/2014</org_study_id>
    <secondary_id>grant ST-44</secondary_id>
    <nct_id>NCT02979275</nct_id>
  </id_info>
  <brief_title>Correlation of Brain and Thenar Muscle Oximetry During Cardiac Surgery With Parameters of Acute Kidney Injury</brief_title>
  <official_title>Correlation of Brain and Thenar Muscle Oximetry During Cardiac Surgery With Parameters of Acute Kidney Injury in Adult Cardiac Surgical Patients Operated on Cardiopulmonary Bypass</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Gdansk</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Gdansk</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Identification of risk factors of acute kidney injury (AKI). It is hypothesized that there&#xD;
      might be a correlation between brain oximetry, tissue saturation of thenar muscle and marker&#xD;
      of AKI in blood - neutrophil gelatinase-associated lipocalin (NGAL) - measured in blood&#xD;
      samples during the first post-op day.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The day before operation, after verification of inclusion and exclusion criteria, the&#xD;
      visiting anesthesiologist will explain to the patient the aim of the study. By signing an&#xD;
      informed consent the patient will be recruited into the study. On the evening before&#xD;
      operation the patient will receive the statin in a dose taken along.&#xD;
&#xD;
      In the OR the anesthesiologist will verify if creatinin and blood urea nitrogen were measured&#xD;
      the day before operation - if not, a blood sample for the test will be obtained and sent to&#xD;
      perform the tests.&#xD;
&#xD;
      Before induction of anesthesia a bi-spectral index (BIS) probe will be placed on the patients&#xD;
      forehead. Above the BIS probe a INVOS(TM) probe for brain oximetry (5100 C Cerebral/Somatic&#xD;
      Oximeter, Somanetics, Medtronic) will be placed.&#xD;
&#xD;
      Brain oximetry by near infrared saturation (NIRS) and tissue saturation on thenar muscle will&#xD;
      be recorded before and during operation on nine timepoints.&#xD;
&#xD;
      As NIRS and thenar muscle saturation are non-routine non-invasive methods of intraoperative&#xD;
      monitoring, patient had to sign an informed consent to participate into the study, and ethic&#xD;
      committee approval for the study protocol was appealed and granted.&#xD;
&#xD;
      General anesthesia will be induced by: fentanyl 0.2 mg, propofol 0.5-1.5 mg/kg in bolus&#xD;
      200ml/godz.; and rocuronium - 0.5 mg/kg. After induction dexamethasone will be given in a&#xD;
      dose of 0,7-1 mg/kg. For conduction of anesthesia before cardiopulmonary bypass (CPB)&#xD;
      sevoflurane will be added to the inhaled mixture of air and oxygen. On CPB propofol will be&#xD;
      given iv. In case of hemodynamic instability after commencing CPB, which will require&#xD;
      catecholamines in a cumulative dose of &gt; 1.5 standard, or in case of trouble to commence CPB,&#xD;
      propofol will be replaced by midazolam in a dose 0.2-0.3 mg/kg/hour.&#xD;
&#xD;
      During anesthesia, first post-operative day and hospital stay a total of 278 variables will&#xD;
      be recorded: hemodynamic parameters, iv fluid doses, inotropes, vasopressors, diuretics,&#xD;
      urine output, transfusions, etc.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">October 2015</start_date>
  <completion_date type="Anticipated">November 2018</completion_date>
  <primary_completion_date type="Anticipated">October 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>NGAL</measure>
    <time_frame>3 hours after operation</time_frame>
    <description>neutrophil gelatinase-associated lipocalin (NGAL) measured in blood samples</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>NGAL on second day</measure>
    <time_frame>second post-op day morning</time_frame>
    <description>neutrophil gelatinase-associated lipocalin (NGAL) measured in blood samples</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cystatin C</measure>
    <time_frame>second post-op day morning</time_frame>
    <description>Cystatin-C measured in blood samples</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum creatinine</measure>
    <time_frame>second post-op day morning</time_frame>
    <description>Serum creatinine in serum</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acute renal failure</measure>
    <time_frame>30 day / any time after operation before discharge from hospital</time_frame>
    <description>Acute renal failure requiring renal replacement therapy or AKIN stage 3</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>In hospital mortality</measure>
    <time_frame>30 day / any time after operation before discharge from hospital</time_frame>
    <description>Death from any reason.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Acute Kidney Injury</condition>
  <condition>Heart Valve Diseases</condition>
  <arm_group>
    <arm_group_label>BRAIN+THENAR MUSCLE INVOS</arm_group_label>
    <description>Patients undergoing open heart surgery on cardiopulmonary bypass.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Open heart surgery on cardiopulmonary bypass.</intervention_name>
    <description>Brain oximetry and tissue saturation will be measured during operation. NGAL, cystatin-C, and Acute Kidney Injury Network (AKIN) criteria of AKI will be assessed durin first post-op day.</description>
    <arm_group_label>BRAIN+THENAR MUSCLE INVOS</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Serum from blood samples obtained at 10 timepoints before, during, and after the cardiac&#xD;
      surgical operation.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patient scheduled for elective on-bypass cardiac surgery (aortic valve surgery,&#xD;
        mitral valve surgery with/without tricuspid valve surgery, ascending aorta surgery&#xD;
        with/without aortic valve surgery).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adult patients&#xD;
&#xD;
          -  signed informed consent&#xD;
&#xD;
          -  scheduled for elective on-bypass cardiac surgery (aortic valve surgery, mitral valve&#xD;
             surgery with/without tricuspid valve surgery, ascending aorta surgery with/without&#xD;
             aortic valve surgery).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  chronic kidney insufficiency (serum creatinine &gt;2 mg/dL)&#xD;
&#xD;
          -  active infection (i.e.: endocarditis)&#xD;
&#xD;
          -  shock or tissue hypoperfusion before operation (blood lactate &gt;3 mmol/L)&#xD;
&#xD;
          -  left ventricle ejection fraction &lt;25%&#xD;
&#xD;
          -  vancomycin used for infection prophylaxis (i.e.: in immunosuppressed patients)&#xD;
&#xD;
          -  history of ischaemic shock&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Romuald Lango, M.D., Ph.D.</last_name>
    <role>Study Director</role>
    <affiliation>Medical University of Gdańsk, Department of Cardiac Anesthesiology</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Romuald Lango, M.D., Ph.D.</last_name>
    <phone>+48583492483</phone>
    <email>rlango@gumed.edu.pl</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Maciej Kowalik, M.D., Ph.D.</last_name>
    <phone>+48583492483</phone>
    <email>mkowalik@gumed.edu.pl</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Medical University of Gdańsk, Department of Cardiac Anesthesiology</name>
      <address>
        <city>Gdansk</city>
        <state>Pomorskie</state>
        <zip>80-211</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Romuald Lango, M.D., Ph.D.</last_name>
      <phone>+48583492483</phone>
      <email>rlango@gumed.edu.pl</email>
    </contact>
    <contact_backup>
      <last_name>Maciej Kowalik, M.D., Ph.D.</last_name>
      <phone>+48583492483</phone>
      <email>mkowalik@gumed.edu.pl</email>
    </contact_backup>
    <investigator>
      <last_name>Wiktor Szymanowicz, M.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>November 21, 2016</study_first_submitted>
  <study_first_submitted_qc>November 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 1, 2016</study_first_posted>
  <last_update_submitted>April 11, 2018</last_update_submitted>
  <last_update_submitted_qc>April 11, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 12, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of Gdansk</investigator_affiliation>
    <investigator_full_name>Romuald Lango</investigator_full_name>
    <investigator_title>Dr hab. med. Romuald Lango</investigator_title>
  </responsible_party>
  <keyword>acute kidney injury</keyword>
  <keyword>cardiopulmonary bypass</keyword>
  <keyword>neutrophil gelatinase-associated lipocalin</keyword>
  <keyword>tissue hypoxia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acute Kidney Injury</mesh_term>
    <mesh_term>Heart Valve Diseases</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Individual participant data (IPD) may be done available to other researchers upon reasonable request directed to study director.</ipd_description>
  </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/NCT02979275
org study id: NKEBN/122/2014
secondary id: grant ST-44
nct id: NCT02979275
lead sponsor: 
has dmc: No
Identification of risk factors of acute kidney injury (AKI). It is hypothesized that there
      might be a correlation between brain oximetry, tissue saturation of thenar muscle and marker
      of AKI in blood - neutrophil gelatinase-associated lipocalin (NGAL) - measured in blood
      samples during the first post-op day.
The day before operation, after verification of inclusion and exclusion criteria, the
      visiting anesthesiologist will explain to the patient the aim of the study. By signing an
      informed consent the patient will be recruited into the study. On the evening before
      operation the patient will receive the statin in a dose taken along.

      In the OR the anesthesiologist will verify if creatinin and blood urea nitrogen were measured
      the day before operation - if not, a blood sample for the test will be obtained and sent to
      perform the tests.

      Before induction of anesthesia a bi-spectral index (BIS) probe will be placed on the patients
      forehead. Above the BIS probe a INVOS(TM) probe for brain oximetry (5100 C Cerebral/Somatic
      Oximeter, Somanetics, Medtronic) will be placed.

      Brain oximetry by near infrared saturation (NIRS) and tissue saturation on thenar muscle will
      be recorded before and during operation on nine timepoints.

      As NIRS and thenar muscle saturation are non-routine non-invasive methods of intraoperative
      monitoring, patient had to sign an informed consent to participate into the study, and ethic
      committee approval for the study protocol was appealed and granted.

      General anesthesia will be induced by: fentanyl 0.2 mg, propofol 0.5-1.5 mg/kg in bolus
      200ml/godz.; and rocuronium - 0.5 mg/kg. After induction dexamethasone will be given in a
      dose of 0,7-1 mg/kg. For conduction of anesthesia before cardiopulmonary bypass (CPB)
      sevoflurane will be added to the inhaled mixture of air and oxygen. On CPB propofol will be
      given iv. In case of hemodynamic instability after commencing CPB, which will require
      catecholamines in a cumulative dose of > 1.5 standard, or in case of trouble to commence CPB,
      propofol will be replaced by midazolam in a dose 0.2-0.3 mg/kg/hour.

      During anesthesia, first post-operative day and hospital stay a total of 278 variables will
      be recorded: hemodynamic parameters, iv fluid doses, inotropes, vasopressors, diuretics,
      urine output, transfusions, etc.
observational model: Case-Control
time perspective: Prospective
measure: NGAL
time frame: 3 hours after operation
description: neutrophil gelatinase-associated lipocalin (NGAL) measured in blood samples
measure: NGAL on second day
time frame: second post-op day morning
description: neutrophil gelatinase-associated lipocalin (NGAL) measured in blood samples
measure: Cystatin C
time frame: second post-op day morning
description: Cystatin-C measured in blood samples
measure: Serum creatinine
time frame: second post-op day morning
description: Serum creatinine in serum
measure: Acute renal failure
time frame: 30 day / any time after operation before discharge from hospital
description: Acute renal failure requiring renal replacement therapy or AKIN stage 3
measure: In hospital mortality
time frame: 30 day / any time after operation before discharge from hospital
description: Death from any reason.
arm group label: BRAIN+THENAR MUSCLE INVOS
description: Patients undergoing open heart surgery on cardiopulmonary bypass.
intervention type: Procedure
intervention name: Open heart surgery on cardiopulmonary bypass.
description: Brain oximetry and tissue saturation will be measured during operation. NGAL, cystatin-C, and Acute Kidney Injury Network (AKIN) criteria of AKI will be assessed durin first post-op day.
arm group label: BRAIN+THENAR MUSCLE INVOS
Serum from blood samples obtained at 10 timepoints before, during, and after the cardiac
      surgical operation.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Romuald Lango, M.D., Ph.D.
role: Study Director
affiliation: Medical University of Gdańsk, Department of Cardiac Anesthesiology
last name: Romuald Lango, M.D., Ph.D.
phone: +48583492483
email: rlango@gumed.edu.pl
last name: Maciej Kowalik, M.D., Ph.D.
phone: +48583492483
email: mkowalik@gumed.edu.pl
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: Poland
responsible party type: Principal Investigator
investigator affiliation: Medical University of Gdansk
investigator full name: Romuald Lango
investigator title: Dr hab. med. Romuald Lango
mesh term: Acute Kidney Injury
mesh term: Heart Valve Diseases
mesh term: Wounds and Injuries
sharing ipd: Undecided
ipd description: Individual participant data (IPD) may be done available to other researchers upon reasonable request directed to study director.