<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/NCT02190487</url>
  </required_header>
  <id_info>
    <org_study_id>3-2011-0076</org_study_id>
    <nct_id>NCT02190487</nct_id>
  </id_info>
  <brief_title>Incidence and Risk Factors of Acute Kidney Injury After Thoracic Aortic Surgery Due to Dissection</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yonsei University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yonsei University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Acute kidney injury (AKI) is one of the most frequently encountered and prognostically&#xD;
      significant complications after cardiovascular surgery. However, there is no definitive&#xD;
      treatment to intervene after development of AKI, therefore, preventive strategy has been the&#xD;
      major issue. By this time, incidence of AKI after cardiovascular surgery has been reported&#xD;
      3-50% based on the studies with various definition of AKI and different patient cohorts.&#xD;
      Development of unified definition for AKI in the early 2000s opened a new era in AKI study.&#xD;
&#xD;
      According to the previous studies, aortic surgery, especially thoracic aortic surgery was&#xD;
      known to be highly prevalent of AKI, which was considered to be caused by use of total&#xD;
      circulatory arrest (TCA), relatively high number of emergency cases, combined malperfusion&#xD;
      syndrome before surgery and relatively complicated surgical procedure. However, there has not&#xD;
      been many studies of AKI in thoracic aortic surgery because of its low incidence and urgent&#xD;
      clinical presentation of aortic pathology, which hinder large randomized controlled study.&#xD;
      Moreover, there are conflicting reports of incidence and risk factors of AKI after thoracic&#xD;
      aortic surgery, no conclusive result has been made. Therefore, this study was designed to&#xD;
      investigate the incidence and risk factors after thoracic aortic surgery only due to&#xD;
      dissection.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2011</start_date>
  <completion_date type="Actual">January 2013</completion_date>
  <primary_completion_date type="Actual">January 2013</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>incidence of acute kidney injury based of RIFLE criteria</measure>
    <time_frame>upto 7 days after surgery</time_frame>
    <description>serum creatinine, GFR were retrospectively retrieved from electrical medical record upto 7days after surgery.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Risk factors of acute kidney injury</measure>
    <time_frame>after diagnosis of acute kidney injury after operation (usually within 7 days after operation)</time_frame>
    <description>age, sex, comorbidities&#xD;
serum creatinine, hemoglobin,mean arterial blood pressure&#xD;
CPB duration, aorta cross clamping duration, total circulatory arrest duration, operative procedures performed, amount of transfused blood components&#xD;
serum creatinine upto 7 days after surgery, mean arterial pressure, cardiac index, amount of transfused blood components in intensive care unit, ventiltor duration, ICU stay duration, renal replacement therapy, 30-day mortality</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">100</enrollment>
  <condition>Dissection of Thoracic Aorta</condition>
  <arm_group>
    <arm_group_label>TAS group</arm_group_label>
    <description>patients who had thoracic aortic surgery due to dissection</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who had thoracic aortic surgery due to dissection&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  thoracic aortic surgery due to dissection&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  chronic kidney disease on renal replacement therapy before surgery&#xD;
&#xD;
          -  death during or within 24 hours after surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yon Hee Shim</last_name>
    <role>Study Director</role>
    <affiliation>Yonsei University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Gangnam Severance Hospital</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 11, 2014</study_first_submitted>
  <study_first_submitted_qc>July 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 15, 2014</study_first_posted>
  <last_update_submitted>July 14, 2014</last_update_submitted>
  <last_update_submitted_qc>July 14, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 16, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT02190487
org study id: 3-2011-0076
nct id: NCT02190487
lead sponsor: 
has dmc: No
Acute kidney injury (AKI) is one of the most frequently encountered and prognostically
      significant complications after cardiovascular surgery. However, there is no definitive
      treatment to intervene after development of AKI, therefore, preventive strategy has been the
      major issue. By this time, incidence of AKI after cardiovascular surgery has been reported
      3-50% based on the studies with various definition of AKI and different patient cohorts.
      Development of unified definition for AKI in the early 2000s opened a new era in AKI study.

      According to the previous studies, aortic surgery, especially thoracic aortic surgery was
      known to be highly prevalent of AKI, which was considered to be caused by use of total
      circulatory arrest (TCA), relatively high number of emergency cases, combined malperfusion
      syndrome before surgery and relatively complicated surgical procedure. However, there has not
      been many studies of AKI in thoracic aortic surgery because of its low incidence and urgent
      clinical presentation of aortic pathology, which hinder large randomized controlled study.
      Moreover, there are conflicting reports of incidence and risk factors of AKI after thoracic
      aortic surgery, no conclusive result has been made. Therefore, this study was designed to
      investigate the incidence and risk factors after thoracic aortic surgery only due to
      dissection.
observational model: Cohort
time perspective: Retrospective
measure: incidence of acute kidney injury based of RIFLE criteria
time frame: upto 7 days after surgery
description: serum creatinine, GFR were retrospectively retrieved from electrical medical record upto 7days after surgery.
measure: Risk factors of acute kidney injury
time frame: after diagnosis of acute kidney injury after operation (usually within 7 days after operation)
description: age, sex, comorbidities
serum creatinine, hemoglobin,mean arterial blood pressure
CPB duration, aorta cross clamping duration, total circulatory arrest duration, operative procedures performed, amount of transfused blood components
serum creatinine upto 7 days after surgery, mean arterial pressure, cardiac index, amount of transfused blood components in intensive care unit, ventiltor duration, ICU stay duration, renal replacement therapy, 30-day mortality
arm group label: TAS group
description: patients who had thoracic aortic surgery due to dissection
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Yon Hee Shim
role: Study Director
affiliation: Yonsei University
facility: 
country: Korea, Republic of
responsible party type: Sponsor