<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/NCT04473144</url>
  </required_header>
  <id_info>
    <org_study_id>MED-MDB_20-257</org_study_id>
    <nct_id>NCT04473144</nct_id>
  </id_info>
  <brief_title>The Effect of Ulistin on Acute Renal Injury in Patients Undergoing OPCAB (Off Pump Coronary Artery Bypass): a Propensity Score Matched Study</brief_title>
  <official_title>The Effect of Ulistin on Acute Renal Injury in Patients Undergoing OPCAB (Off Pump Coronary Artery Bypass): a Propensity Score Matched Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ajou University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ajou University School of Medicine</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Acute kidney injury (AKI) is a frequent complication after cardiac surgery. AKI has been&#xD;
      reported as 7-40% depending on the type of surgery, and is known to increase to about 50%&#xD;
      when there are risk factors. Cardiac surgery-associated AKI (CSA-AKI) requires cardiac&#xD;
      replacement therapy in 1-5% of patients and increases mortality to 1,4%, but the treatment is&#xD;
      still unknown. Therefore prevention of occurrence is very important.&#xD;
&#xD;
      Known factors related to the development of CSA-AKI include hemodynamic, inflammatory,&#xD;
      metabolic, and nephrotoxic factors, and since there is a close connection between hypotension&#xD;
      due to deterioration of cardiac function, preventive measures to prevent hypotension in&#xD;
      juicing It is only possible.&#xD;
&#xD;
      To date, strategies to protect kidneys with drugs are very limited. Urinary trypsin&#xD;
      inhibitor, ulistine, has anti-inflammatory and antioxidant effects, so it has been reported&#xD;
      to protect against renal ischemia/reperfusion injury. Various studies have been attempted to&#xD;
      prevent CSA-AKI, but most of them are inflammatory reactions during surgery. It was performed&#xD;
      only for surgery with extracorporeal circulation that causes severely.&#xD;
&#xD;
      Therefore, this study would like to verify the effectiveness of ulistine's medicine in the&#xD;
      prevention of CSA-AKI in patients undergoing coronary artery bypass surgery without&#xD;
      extracorporeal circulation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">August 1, 2020</start_date>
  <completion_date type="Anticipated">August 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">July 1, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The incidence of acute kidney injury</measure>
    <time_frame>7 days after operation</time_frame>
    <description>Cr ≥ 0.3 mg/dl within 48 hours after surgery, 1.5 times higher preoperative value within 7 days, urine volume &lt;0.5 ml/kg for 6 hours after surgery</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Acute Kidney Injury</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Anesthesia induction and maintenance and postoperative recovery management were performed according to the standard anesthesia protocol for off pump coronary artery bypass surgery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ulistin</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>In the Ulistine administration group, 300,000 KIU was mixed with 100 mL physiological saline and administered over 15 minutes after induction of anesthesia.&#xD;
Anesthesia induction and maintenance and postoperative recovery management were performed according to the standard anesthesia protocol for off pump coronary artery bypass surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ulinastatin</intervention_name>
    <description>In the Ulistine administration group, 300,000 KIU was mixed with 100 mL physiological saline and administered over 15 minutes after induction of anesthesia.</description>
    <arm_group_label>Ulistin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  From January 2015 to June 2020, a retrospective study will be conducted on patients&#xD;
             undergoing extracorporeal circulatory coronary artery bypass surgery at Ajou&#xD;
             University Hospital.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who were undergoing renal replacement therapy prior to surgery due to&#xD;
             end-stage renal failure are excluded from the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>ji young yoo, assistant professor</last_name>
    <phone>821056902104</phone>
    <email>springbear@nate.com</email>
  </overall_contact>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 8, 2020</study_first_submitted>
  <study_first_submitted_qc>July 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 16, 2020</study_first_posted>
  <last_update_submitted>July 15, 2020</last_update_submitted>
  <last_update_submitted_qc>July 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ajou University School of Medicine</investigator_affiliation>
    <investigator_full_name>Jiyoung Yoo</investigator_full_name>
    <investigator_title>Assistant professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acute Kidney Injury</mesh_term>
    <mesh_term>Wounds and Injuries</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinastatin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04473144
org study id: MED-MDB_20-257
nct id: NCT04473144
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Acute kidney injury (AKI) is a frequent complication after cardiac surgery. AKI has been
      reported as 7-40% depending on the type of surgery, and is known to increase to about 50%
      when there are risk factors. Cardiac surgery-associated AKI (CSA-AKI) requires cardiac
      replacement therapy in 1-5% of patients and increases mortality to 1,4%, but the treatment is
      still unknown. Therefore prevention of occurrence is very important.

      Known factors related to the development of CSA-AKI include hemodynamic, inflammatory,
      metabolic, and nephrotoxic factors, and since there is a close connection between hypotension
      due to deterioration of cardiac function, preventive measures to prevent hypotension in
      juicing It is only possible.

      To date, strategies to protect kidneys with drugs are very limited. Urinary trypsin
      inhibitor, ulistine, has anti-inflammatory and antioxidant effects, so it has been reported
      to protect against renal ischemia/reperfusion injury. Various studies have been attempted to
      prevent CSA-AKI, but most of them are inflammatory reactions during surgery. It was performed
      only for surgery with extracorporeal circulation that causes severely.

      Therefore, this study would like to verify the effectiveness of ulistine's medicine in the
      prevention of CSA-AKI in patients undergoing coronary artery bypass surgery without
      extracorporeal circulation.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: The incidence of acute kidney injury
time frame: 7 days after operation
description: Cr ≥ 0.3 mg/dl within 48 hours after surgery, 1.5 times higher preoperative value within 7 days, urine volume <0.5 ml/kg for 6 hours after surgery
arm group label: Control
arm group type: No Intervention
description: Anesthesia induction and maintenance and postoperative recovery management were performed according to the standard anesthesia protocol for off pump coronary artery bypass surgery.
arm group label: Ulistin
arm group type: Sham Comparator
description: In the Ulistine administration group, 300,000 KIU was mixed with 100 mL physiological saline and administered over 15 minutes after induction of anesthesia.
Anesthesia induction and maintenance and postoperative recovery management were performed according to the standard anesthesia protocol for off pump coronary artery bypass surgery.
intervention type: Drug
intervention name: Ulinastatin
description: In the Ulistine administration group, 300,000 KIU was mixed with 100 mL physiological saline and administered over 15 minutes after induction of anesthesia.
arm group label: Ulistin
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: ji young yoo, assistant professor
phone: 821056902104
email: springbear@nate.com
responsible party type: Principal Investigator
investigator affiliation: Ajou University School of Medicine
investigator full name: Jiyoung Yoo
investigator title: Assistant professor
mesh term: Acute Kidney Injury
mesh term: Wounds and Injuries
mesh term: Urinastatin
sharing ipd: No