<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/NCT03776305</url>
  </required_header>
  <id_info>
    <org_study_id>IMIECMO2018</org_study_id>
    <nct_id>NCT03776305</nct_id>
  </id_info>
  <brief_title>Imipenem in Critically Ill Patients</brief_title>
  <official_title>Pharmacokinetics of Imipenem in Critically Ill Patients With Life-threatening Severe Infections During Support With Extracorporeal Membrane Oxygenation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Prince of Songkla University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Prince of Songkla University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Extracorporeal membrane oxygenation (ECMO) has become increasingly used for lifesaving&#xD;
      respiratory and/or cardiac failure support in critically ill patients, including those with&#xD;
      life-threatening severe infections. This cardiopulmonary bypass device has been shown to&#xD;
      enhance the profound pathophysiological changes in this patient population, resulting in an&#xD;
      alteration of the pharmacokinetics (PK) of antimicrobial agents. The aim of this study was to&#xD;
      determine the effect of ECMO on the PK of imipenem in critically ill patients supported by&#xD;
      this cardiopulmonary bypass device.&#xD;
&#xD;
      Methods The study was conducted in critically ill patients with respiratory and/or cardiac&#xD;
      failure and suspected severe nosocomial infections who were supported by ECMO. All patients&#xD;
      received a 1-h infusion of 0.5 g of imipenem every 6 h and imipenem PK studies were carried&#xD;
      out on the fourth dose of drug administration.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">December 1, 2015</start_date>
  <completion_date type="Anticipated">December 30, 2020</completion_date>
  <primary_completion_date type="Actual">February 1, 2018</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Concentration of imipenem in plasma</measure>
    <time_frame>6 hour after the imipenem dose</time_frame>
    <description>Individual concentration of imipenem in plasma</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">12</enrollment>
  <condition>Critically Ill Patients With ECMO</condition>
  <arm_group>
    <arm_group_label>Imipenem ECMO</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>1-h infusion of 0.5 g of imipenem, q6h</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Imipenem</intervention_name>
    <description>1-h infusion of 0.5 g of imipenem diluted in 100 mL of normal saline solution, delivered via infusion pump at a constant flow rate, every 6 h. The imipenem PK studies were carried out during administration of the fourth dose of each regimen (18-24 h after the start of the regimen). Blood samples were obtained by direct venipuncture at the following times: before (time zero) and 0.25, 0.5, 0.75, 1, 2, 3, 4, 5 and 6 h after the fourth dose of each regimen.</description>
    <arm_group_label>Imipenem ECMO</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient age &gt;18 year&#xD;
&#xD;
          -  Patients who diagnosed as severe sepsis&#xD;
&#xD;
          -  Admitted into the ICU&#xD;
&#xD;
          -  Supported with ECMO&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who pregnant&#xD;
&#xD;
          -  Patients who have documented hypersensitivity to carbapenem&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Division of Clinical Pharmacology, Department of Medicine, Faculty of Medicine, Prince of Songkla University</name>
      <address>
        <city>Hat Yai</city>
        <state>Songkla</state>
        <zip>90110</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 11, 2018</study_first_submitted>
  <study_first_submitted_qc>December 12, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 14, 2018</study_first_posted>
  <last_update_submitted>February 13, 2019</last_update_submitted>
  <last_update_submitted_qc>February 13, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Prince of Songkla University</investigator_affiliation>
    <investigator_full_name>Sutep Jaruratanasirikul</investigator_full_name>
    <investigator_title>Principle Investigator</investigator_title>
  </responsible_party>
  <keyword>pharmacokinetic</keyword>
  <keyword>imipenem</keyword>
  <keyword>extracorporeal membrane oxygenation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Critical Illness</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Imipenem</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/NCT03776305
org study id: IMIECMO2018
nct id: NCT03776305
lead sponsor: 
has dmc: No
Extracorporeal membrane oxygenation (ECMO) has become increasingly used for lifesaving
      respiratory and/or cardiac failure support in critically ill patients, including those with
      life-threatening severe infections. This cardiopulmonary bypass device has been shown to
      enhance the profound pathophysiological changes in this patient population, resulting in an
      alteration of the pharmacokinetics (PK) of antimicrobial agents. The aim of this study was to
      determine the effect of ECMO on the PK of imipenem in critically ill patients supported by
      this cardiopulmonary bypass device.

      Methods The study was conducted in critically ill patients with respiratory and/or cardiac
      failure and suspected severe nosocomial infections who were supported by ECMO. All patients
      received a 1-h infusion of 0.5 g of imipenem every 6 h and imipenem PK studies were carried
      out on the fourth dose of drug administration.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Concentration of imipenem in plasma
time frame: 6 hour after the imipenem dose
description: Individual concentration of imipenem in plasma
arm group label: Imipenem ECMO
arm group type: Experimental
description: 1-h infusion of 0.5 g of imipenem, q6h
intervention type: Drug
intervention name: Imipenem
description: 1-h infusion of 0.5 g of imipenem diluted in 100 mL of normal saline solution, delivered via infusion pump at a constant flow rate, every 6 h. The imipenem PK studies were carried out during administration of the fourth dose of each regimen (18-24 h after the start of the regimen). Blood samples were obtained by direct venipuncture at the following times: before (time zero) and 0.25, 0.5, 0.75, 1, 2, 3, 4, 5 and 6 h after the fourth dose of each regimen.
arm group label: Imipenem ECMO
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
facility: 
country: Thailand
responsible party type: Principal Investigator
investigator affiliation: Prince of Songkla University
investigator full name: Sutep Jaruratanasirikul
investigator title: Principle Investigator
mesh term: Critical Illness
mesh term: Imipenem