<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/NCT03806543</url>
  </required_header>
  <id_info>
    <org_study_id>2018ZDSYLL117-P01</org_study_id>
    <nct_id>NCT03806543</nct_id>
  </id_info>
  <brief_title>The Influencing Factors of Vancomycin Trough Level and the Rate Achieving the Target Trough Level</brief_title>
  <official_title>The Influencing Factors of Vancomycin Trough Level and the Rate Achieving the Target Trough Level in Critically Ill Patients: A Retrospective Observational Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Southeast University, China</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Southeast University, China</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>
      The aim of this study was to assess factors that may influence vancomycin trough level and&#xD;
      the rate achieving the target trough level in critically ill patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This retrospective observational study included adult patients treated with intravenous&#xD;
      vancomycin in intensive care unit of Zhongda Hospital from January 2015 to December 2017.&#xD;
      Vancomycin dose was based on international consensus and adjusted according to estimated&#xD;
      glomerular filtration rate (eGFR) calculated by the Cockcroft-Gault equation. vancomycin&#xD;
      trough level (VTL) was retained at steady state (after the third dose). Linear regression was&#xD;
      performed to determine the correlation between factors prior to the first vancomycin dose and&#xD;
      VTL. Distribution of VTL and percentage of patients achieving the target trough level&#xD;
      (15-20mg/L) was observed in different renal function.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2015</start_date>
  <completion_date type="Actual">December 31, 2017</completion_date>
  <primary_completion_date type="Actual">December 31, 2017</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of patients achieving the target vancomycin trough（15-20mg/L）</measure>
    <time_frame>3 years</time_frame>
    <description>Vancomycin trough level was retained at steady state (after the third dose). If a patient has multiple measurements of vancomycin trough level, the first measurement is collected.Rate of patients achieving the target trough level (15-20mg/L) was observed.</description>
  </primary_outcome>
  <enrollment type="Actual">165</enrollment>
  <condition>Vancomycin</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vancomycin</intervention_name>
    <description>adult patients treated with intravenous vancomycin in intensive care unit</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients (age≥18 years) treated with intravenous vancomycin were included. Exclusion&#xD;
        criteria were chronic renal dysfunction and acute renal injury patients treated with Renal&#xD;
        Replacement therapy, VTL was not retained at steady-state, vancomycin treatment time≤48h,&#xD;
        vancomycin dose did not meet study definitions, palliative care.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult ICU patients (age≥18 years) treated with intravenous vancomycin were included&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Chronic renal dysfunction and acute renal injury patients treated with Renal&#xD;
             Replacement therapy&#xD;
&#xD;
          -  VTL was not retained at steady-state&#xD;
&#xD;
          -  Vancomycin treatment time≤48h&#xD;
&#xD;
          -  Vancomycin dose did not meet study definitions&#xD;
&#xD;
          -  Palliative care&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jingyuan Xu, PHD.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Southeast University</affiliation>
  </overall_official>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>December 22, 2018</study_first_submitted>
  <study_first_submitted_qc>January 15, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 16, 2019</study_first_posted>
  <last_update_submitted>January 15, 2019</last_update_submitted>
  <last_update_submitted_qc>January 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 16, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Southeast University, China</investigator_affiliation>
    <investigator_full_name>Jingyuan,Xu</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vancomycin</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/NCT03806543
org study id: 2018ZDSYLL117-P01
nct id: NCT03806543
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study was to assess factors that may influence vancomycin trough level and
      the rate achieving the target trough level in critically ill patients.
This retrospective observational study included adult patients treated with intravenous
      vancomycin in intensive care unit of Zhongda Hospital from January 2015 to December 2017.
      Vancomycin dose was based on international consensus and adjusted according to estimated
      glomerular filtration rate (eGFR) calculated by the Cockcroft-Gault equation. vancomycin
      trough level (VTL) was retained at steady state (after the third dose). Linear regression was
      performed to determine the correlation between factors prior to the first vancomycin dose and
      VTL. Distribution of VTL and percentage of patients achieving the target trough level
      (15-20mg/L) was observed in different renal function.
observational model: Case-Only
time perspective: Retrospective
measure: Rate of patients achieving the target vancomycin trough（15-20mg/L）
time frame: 3 years
description: Vancomycin trough level was retained at steady state (after the third dose). If a patient has multiple measurements of vancomycin trough level, the first measurement is collected.Rate of patients achieving the target trough level (15-20mg/L) was observed.
intervention type: Drug
intervention name: Vancomycin
description: adult patients treated with intravenous vancomycin in intensive care unit
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jingyuan Xu, PHD.
role: Principal Investigator
affiliation: Southeast University
responsible party type: Principal Investigator
investigator affiliation: Southeast University, China
investigator full name: Jingyuan,Xu
investigator title: Principal Investigator
mesh term: Vancomycin