<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/NCT02233010</url>
  </required_header>
  <id_info>
    <org_study_id>postOPNGAL01</org_study_id>
    <nct_id>NCT02233010</nct_id>
  </id_info>
  <brief_title>Usefulness of Neutrophil Gelatinase-associated Lipocalin(NGAL) to Confirm Acute Kidney Function Decrease of the Patients Who Had Non-cardiac Surgery</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Inje University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Inje University</source>
  <brief_summary>
    <textblock>
      Although post-op renal function decrease is determined by serum creatinine, serum creatinine&#xD;
      has disadvantages that it increases a long time after renal function decrease and it has&#xD;
      various increasing time based on the level of renal function. Neutrophil&#xD;
      Gelatinase-associated Lipocalin (NGAL's) usefulness as an evidence for acute kidney damage&#xD;
      occurring from post-op cardiac surgery, being critical patients and contrast medium use is&#xD;
      already proven.&#xD;
&#xD;
      But NGAL's usefulness for renal function after non-cardiac surgery is not proven and&#xD;
      especially, NGAL's usefulness for renal injury after non-cardiac surgery in chronic renal&#xD;
      disease patients is not proven.Therefore, the investigators will study about renal function&#xD;
      decrease after non-cardiac surgery with NGAL and serum creatinine.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2014</start_date>
  <primary_completion_date type="Actual">August 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>serum NGAL level</measure>
    <time_frame>up to post operation 12 hours</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">43</enrollment>
  <condition>Chronic Kidney Disease</condition>
  <arm_group>
    <arm_group_label>kidney function normal group</arm_group_label>
    <description>kidney function normal group : defined by the normal level of NGAL after post operation 4hrs</description>
  </arm_group>
  <arm_group>
    <arm_group_label>kidney function decreased group</arm_group_label>
    <description>kidney function decreased group : defined by the increased level of NGAL after post operation 4hrs</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>The level of NGAL after pre op,post op 4hr, post op 12hr</intervention_name>
    <arm_group_label>kidney function decreased group</arm_group_label>
    <arm_group_label>kidney function normal group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        43 patients who had non-cardiac surgery in Seoul Paik Hospital.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  43 patients who had non-cardiac surgery in Seoul Paik Hospital.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  have viral hepatitis and Aspartate aminotransferase, Alanine aminotransferase &gt; 2 time&#xD;
             of normal level&#xD;
&#xD;
          -  severe lung disease&#xD;
&#xD;
          -  severe heart failure ( Ejection Fraction &lt; 40% )&#xD;
&#xD;
          -  pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>79 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 1, 2014</study_first_submitted>
  <study_first_submitted_qc>September 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 8, 2014</study_first_posted>
  <last_update_submitted>September 5, 2014</last_update_submitted>
  <last_update_submitted_qc>September 5, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 8, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Inje University</investigator_affiliation>
    <investigator_full_name>Hoseok Koo</investigator_full_name>
    <investigator_title>Hoseok Koo</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Renal Insufficiency, Chronic</mesh_term>
  </condition_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/NCT02233010
org study id: postOPNGAL01
nct id: NCT02233010
lead sponsor: 
Although post-op renal function decrease is determined by serum creatinine, serum creatinine
      has disadvantages that it increases a long time after renal function decrease and it has
      various increasing time based on the level of renal function. Neutrophil
      Gelatinase-associated Lipocalin (NGAL's) usefulness as an evidence for acute kidney damage
      occurring from post-op cardiac surgery, being critical patients and contrast medium use is
      already proven.

      But NGAL's usefulness for renal function after non-cardiac surgery is not proven and
      especially, NGAL's usefulness for renal injury after non-cardiac surgery in chronic renal
      disease patients is not proven.Therefore, the investigators will study about renal function
      decrease after non-cardiac surgery with NGAL and serum creatinine.
observational model: Case-Only
time perspective: Prospective
measure: serum NGAL level
time frame: up to post operation 12 hours
arm group label: kidney function normal group
description: kidney function normal group : defined by the normal level of NGAL after post operation 4hrs
arm group label: kidney function decreased group
description: kidney function decreased group : defined by the increased level of NGAL after post operation 4hrs
intervention type: Other
intervention name: The level of NGAL after pre op,post op 4hr, post op 12hr
arm group label: kidney function decreased group
arm group label: kidney function normal group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 79 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Inje University
investigator full name: Hoseok Koo
investigator title: Hoseok Koo
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic