<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/NCT03308214</url>
  </required_header>
  <id_info>
    <org_study_id>2017ZDSYLL073-P01</org_study_id>
    <nct_id>NCT03308214</nct_id>
  </id_info>
  <brief_title>The Analysis of Factors Influencing the Vd of Imipenem in Septic Shock Patients</brief_title>
  <official_title>The Analysis of Factors Influencing the Apparent Volume of Distribution of Imipenem in Septic Shock Patients</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>Yes</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 study measures the plasma concentrations of imipenem in septic shock patients and&#xD;
      non-septic shock patients and observes hypoalbuminemia and the impact of the severity of&#xD;
      critical illness on Vd&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Severe sepsis and septic shock are major causes of mortality in intensive care unit(ICU)&#xD;
      patients.Correct and adequate antibiotic coverage is essential but can be complex as a result&#xD;
      of fluid resuscitation, hypoalbuminemia, organ dysfunction, the application of extracorporeal&#xD;
      support modalities and the impact of critical illness on pharmacokinetics(PK).Such changes&#xD;
      will significantly distort the normal anti-biotic PK profile, resulting in drug exposure that&#xD;
      is markedly different from the 'healthy volunteer.'The apparent volume of distribution is one&#xD;
      of important PK parameters.Vd determines the loading dose. This review article considers&#xD;
      these issues in detail, summarizing the key changes in antibiotic Vd in the critically ill,&#xD;
      and providing general suggestions how to optimization of antibiotic dosing to manage Vd&#xD;
      challenges.50 patients who receives the theapy of imipenem are included in this study.Whether&#xD;
      hypoalbuminemia, organ dysfunction, the application of extracorporeal support modalities and&#xD;
      the impact of critical illness on Vd will be evaluted.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 18, 2018</start_date>
  <completion_date type="Actual">December 28, 2018</completion_date>
  <primary_completion_date type="Actual">December 28, 2018</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>the apparent volume of distribution</measure>
    <time_frame>Day1, Day 3, Day 7</time_frame>
    <description>The imipenem plasma concentrations are measured at different time to calculate Vd</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">25</enrollment>
  <condition>Septic Shock</condition>
  <arm_group>
    <arm_group_label>septic shock</arm_group_label>
    <description>Patients with septic shock treat with Imipenem</description>
  </arm_group>
  <arm_group>
    <arm_group_label>non-septic shock</arm_group_label>
    <description>Patients with infection but not septic shock treat with Imipenem</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Imipenem</intervention_name>
    <description>Imipenem 1.0 q 8h</description>
    <arm_group_label>non-septic shock</arm_group_label>
    <arm_group_label>septic shock</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        septic shock patients and non-septic shock patients with the therapy of imipenem in the ICU&#xD;
        of Zhongda hospital&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. age between 18 years old and 80 years old;&#xD;
&#xD;
          2. Admitted to the ICU;&#xD;
&#xD;
          3. Patients diagnosed as septic shock requiring the therapy of imipenem(0.5g q6h or 1.0g&#xD;
             q8h;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patient participated in another interventional trial before enrollment&#xD;
&#xD;
          2. Allergy, hypersensitivity or a serious reaction to imipenem;&#xD;
&#xD;
          3. Pregnancy.&#xD;
&#xD;
          4. patients with ECMO and(or)CRRT.&#xD;
&#xD;
          5. tumors.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Songqiao Liu, PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Study Investigator</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Zhongda Hospital, Southeast University</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210009</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>September 25, 2017</study_first_submitted>
  <study_first_submitted_qc>October 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 12, 2017</study_first_posted>
  <last_update_submitted>January 1, 2021</last_update_submitted>
  <last_update_submitted_qc>January 1, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 5, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Southeast University, China</investigator_affiliation>
    <investigator_full_name>Songqiao Liu</investigator_full_name>
    <investigator_title>MD. PHD</investigator_title>
  </responsible_party>
  <keyword>septic shock; imipenem; VD ;pharmacokinetics</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Shock, Septic</mesh_term>
    <mesh_term>Shock</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Imipenem</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/NCT03308214
org study id: 2017ZDSYLL073-P01
nct id: NCT03308214
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The study measures the plasma concentrations of imipenem in septic shock patients and
      non-septic shock patients and observes hypoalbuminemia and the impact of the severity of
      critical illness on Vd
Severe sepsis and septic shock are major causes of mortality in intensive care unit(ICU)
      patients.Correct and adequate antibiotic coverage is essential but can be complex as a result
      of fluid resuscitation, hypoalbuminemia, organ dysfunction, the application of extracorporeal
      support modalities and the impact of critical illness on pharmacokinetics(PK).Such changes
      will significantly distort the normal anti-biotic PK profile, resulting in drug exposure that
      is markedly different from the 'healthy volunteer.'The apparent volume of distribution is one
      of important PK parameters.Vd determines the loading dose. This review article considers
      these issues in detail, summarizing the key changes in antibiotic Vd in the critically ill,
      and providing general suggestions how to optimization of antibiotic dosing to manage Vd
      challenges.50 patients who receives the theapy of imipenem are included in this study.Whether
      hypoalbuminemia, organ dysfunction, the application of extracorporeal support modalities and
      the impact of critical illness on Vd will be evaluted.
observational model: Case-Only
time perspective: Prospective
measure: the apparent volume of distribution
time frame: Day1, Day 3, Day 7
description: The imipenem plasma concentrations are measured at different time to calculate Vd
arm group label: septic shock
description: Patients with septic shock treat with Imipenem
arm group label: non-septic shock
description: Patients with infection but not septic shock treat with Imipenem
intervention type: Drug
intervention name: Imipenem
description: Imipenem 1.0 q 8h
arm group label: non-septic shock
arm group label: septic shock
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
last name: Songqiao Liu, PHD
role: Principal Investigator
affiliation: Study Investigator
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Southeast University, China
investigator full name: Songqiao Liu
investigator title: MD. PHD
mesh term: Shock, Septic
mesh term: Shock
mesh term: Imipenem
sharing ipd: No