<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/NCT03785132</url>
  </required_header>
  <id_info>
    <org_study_id>PM_cardiac surgery</org_study_id>
    <nct_id>NCT03785132</nct_id>
  </id_info>
  <brief_title>Performance Measurement in Cardiac Surgery</brief_title>
  <official_title>Relationship Between Performance Measurement of Intraoperative Mean Arterial Pressure and Mortality in Patients Undergoing Cardiac Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aimed to evaluate the relationship between the perioperative blood pressure and&#xD;
      postoperative mortality after cardiac surgery using performance measurement (PM) of mean&#xD;
      arterial pressure (MAP).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The authors conducted a retrospective cohort study of adult patients who underwent cardiac&#xD;
      surgery requiring cardiopulmonary bypass (CPB). Median performance error (MDPE), median&#xD;
      absolute performance error (MDAPE), and wobble of MAP were calculated using preoperative MAP&#xD;
      as the reference value, and MBPs before, during and after the bypass as measured values.&#xD;
      Univariable and multivariable logistic regression analyses were performed using PM parameters&#xD;
      to predict in-hospital mortality. Survival after cardiac surgery was compared using the Cox&#xD;
      proportional hazard model. Predictability of PM was assessed using the area under the&#xD;
      receiver-operating characteristic curve (AUROC).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2018</start_date>
  <completion_date type="Actual">November 1, 2019</completion_date>
  <primary_completion_date type="Actual">November 1, 2019</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Mortality</measure>
    <time_frame>through study completion, average 3 years</time_frame>
    <description>mortality after cardiac surgery</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">1300</enrollment>
  <condition>Blood Pressure</condition>
  <arm_group>
    <arm_group_label>cardiac surgery</arm_group_label>
    <description>Patients who underwent cardiac surgery with cardiopulmonary bypass</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Cardiac surgery</intervention_name>
    <description>The relationship between performance measurement of blood pressure during cardiac surgery (before, during and after cardiopulmonary bypass) and postoperative mortality</description>
    <arm_group_label>cardiac surgery</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients undergoing cardiac surgery with cardiopulmonary bypass between 2013 and 2016&#xD;
        at Seoul National University Hospital&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing cardiac surgery with cardiopulmonary bypass between 2013 and 2016&#xD;
             at Seoul National University Hospital.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients without information on preoperative blood pressure or mortality.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Youn Joung Cho, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>03080</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <results_reference>
    <citation>Lee HC, Ryu HG, Jung CW. Performance measurement of intraoperative systolic arterial pressure to predict in-hospital mortality in adult liver transplantation. Sci Rep. 2017 Aug 1;7(1):7030. doi: 10.1038/s41598-017-07664-0.</citation>
    <PMID>28765633</PMID>
  </results_reference>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>December 20, 2018</study_first_submitted>
  <study_first_submitted_qc>December 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 24, 2018</study_first_posted>
  <last_update_submitted>March 3, 2020</last_update_submitted>
  <last_update_submitted_qc>March 3, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Hospital</investigator_affiliation>
    <investigator_full_name>Youn Joung Cho, MD</investigator_full_name>
    <investigator_title>Clinical assistant professor</investigator_title>
  </responsible_party>
  <keyword>blood pressure</keyword>
  <keyword>performance measurement</keyword>
  <keyword>cardiac surgery</keyword>
  <keyword>mortality</keyword>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03785132
org study id: PM_cardiac surgery
nct id: NCT03785132
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study aimed to evaluate the relationship between the perioperative blood pressure and
      postoperative mortality after cardiac surgery using performance measurement (PM) of mean
      arterial pressure (MAP).
The authors conducted a retrospective cohort study of adult patients who underwent cardiac
      surgery requiring cardiopulmonary bypass (CPB). Median performance error (MDPE), median
      absolute performance error (MDAPE), and wobble of MAP were calculated using preoperative MAP
      as the reference value, and MBPs before, during and after the bypass as measured values.
      Univariable and multivariable logistic regression analyses were performed using PM parameters
      to predict in-hospital mortality. Survival after cardiac surgery was compared using the Cox
      proportional hazard model. Predictability of PM was assessed using the area under the
      receiver-operating characteristic curve (AUROC).
observational model: Cohort
time perspective: Retrospective
measure: Mortality
time frame: through study completion, average 3 years
description: mortality after cardiac surgery
arm group label: cardiac surgery
description: Patients who underwent cardiac surgery with cardiopulmonary bypass
intervention type: Procedure
intervention name: Cardiac surgery
description: The relationship between performance measurement of blood pressure during cardiac surgery (before, during and after cardiopulmonary bypass) and postoperative mortality
arm group label: cardiac surgery
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Youn Joung Cho, MD
role: Principal Investigator
affiliation: Seoul National University Hospital
facility: 
country: Korea, Republic of
citation: Lee HC, Ryu HG, Jung CW. Performance measurement of intraoperative systolic arterial pressure to predict in-hospital mortality in adult liver transplantation. Sci Rep. 2017 Aug 1;7(1):7030. doi: 10.1038/s41598-017-07664-0.
PMID: 28765633
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Hospital
investigator full name: Youn Joung Cho, MD
investigator title: Clinical assistant professor
sharing ipd: Undecided