<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/NCT02258906</url>
  </required_header>
  <id_info>
    <org_study_id>4-2014-0633</org_study_id>
    <nct_id>NCT02258906</nct_id>
  </id_info>
  <brief_title>Effect of Ulinastatin on Postoperative Renal Function in Patients Undergoing Robot-assisted Laparoscopic Partial Nephrectomy</brief_title>
  <official_title>Effect of Ulinastatin on Postoperative Renal Function in Patients Undergoing Robot-assisted Laparoscopic Partial Nephrectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yonsei University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yonsei University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Ulinastatin reduces systemic inflammatory responses and protects organs from&#xD;
      ischemia/reperfusion-induced injury. The aim of this study is to evaluate the effect of&#xD;
      ulinastatin on postoperative renal function in patients undergoing robot-assisted&#xD;
      laparoscopic partial nephrectomy. Seventy patients, aged 20 to 79 years, scheduled for&#xD;
      robot-assisted laparoscopic partial nephrectomy will be divided into ulinastatin (n=35) and&#xD;
      control (n=35) groups. Randomly selected patients of the ulinastatin group are given&#xD;
      ulinastatin. In contrast, patients in the control group receive an equivalent volume of&#xD;
      normal saline as a placebo. The primary endpoints are postoperative renal function measured&#xD;
      by serum creatinine, cystatin C, and urine output.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">July 2016</completion_date>
  <primary_completion_date type="Actual">July 2016</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>Prevention</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>postoperative renal function</measure>
    <time_frame>for 3 days after surgery</time_frame>
    <description>Postoperative renal function measured by serum creatinine, cystatin C, and urine output</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>systemic inflammatory response</measure>
    <time_frame>for 3 days after surgery</time_frame>
    <description>the systemic inflammatory response measured by WBC, Neutrophil (%), and CRP</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">66</enrollment>
  <condition>Renal Mass</condition>
  <arm_group>
    <arm_group_label>Ulinastatin group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in the ulinastatin group are given ulinastatin during operation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Patients in the control group receive the same volume of normal saline during operation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ulinastatin</intervention_name>
    <arm_group_label>Ulinastatin group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>normal saline</intervention_name>
    <arm_group_label>control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients who are scheduled to undergo robot-assisted laparoscopic partial nephrectomy&#xD;
             with an American Society of Anesthesiologists (ASA) physical status I-III&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects are ineligible if they have severe respiratory or cardiovascular disease,&#xD;
             renal insufficiency before operation, cognitive dysfunction, are unable to communicate&#xD;
             or speak Korean&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>79 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Severance Hospital, Yonsei University College of Medicine</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>August 2016</verification_date>
  <study_first_submitted>October 2, 2014</study_first_submitted>
  <study_first_submitted_qc>October 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 8, 2014</study_first_posted>
  <last_update_submitted>August 23, 2016</last_update_submitted>
  <last_update_submitted_qc>August 23, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 25, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinastatin</mesh_term>
  </intervention_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/NCT02258906
org study id: 4-2014-0633
nct id: NCT02258906
lead sponsor: 
has dmc: Yes
Ulinastatin reduces systemic inflammatory responses and protects organs from
      ischemia/reperfusion-induced injury. The aim of this study is to evaluate the effect of
      ulinastatin on postoperative renal function in patients undergoing robot-assisted
      laparoscopic partial nephrectomy. Seventy patients, aged 20 to 79 years, scheduled for
      robot-assisted laparoscopic partial nephrectomy will be divided into ulinastatin (n=35) and
      control (n=35) groups. Randomly selected patients of the ulinastatin group are given
      ulinastatin. In contrast, patients in the control group receive an equivalent volume of
      normal saline as a placebo. The primary endpoints are postoperative renal function measured
      by serum creatinine, cystatin C, and urine output.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Care Provider)
measure: postoperative renal function
time frame: for 3 days after surgery
description: Postoperative renal function measured by serum creatinine, cystatin C, and urine output
measure: systemic inflammatory response
time frame: for 3 days after surgery
description: the systemic inflammatory response measured by WBC, Neutrophil (%), and CRP
arm group label: Ulinastatin group
arm group type: Experimental
description: Patients in the ulinastatin group are given ulinastatin during operation.
arm group label: control group
arm group type: Placebo Comparator
description: Patients in the control group receive the same volume of normal saline during operation.
intervention type: Drug
intervention name: ulinastatin
arm group label: Ulinastatin group
intervention type: Drug
intervention name: normal saline
arm group label: control group
criteria: 
gender: All
minimum age: 20 Years
maximum age: 79 Years
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Urinastatin