<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/NCT03766282</url>
  </required_header>
  <id_info>
    <org_study_id>2017-2-QN-15</org_study_id>
    <nct_id>NCT03766282</nct_id>
  </id_info>
  <brief_title>Pharmacokinetics in Extracorporeal Membrane Oxygenation</brief_title>
  <official_title>Pharmacokinetics of Antibiotics, Sedative and Analgesic During Extracorporeal Membrane Oxygenation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>China-Japan Friendship Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>China-Japan Friendship Hospital</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 main purpose of the present study is to investigate the risk factors that affect drug&#xD;
      pharmacokinetic (PK) during extracorporeal membrane oxygenation (ECMO). To advance&#xD;
      understanding of PK variance and improve the patients outcomes during ECMO.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Ex vivo experiments for drug stability testing and ECMO circuits testing in animal models.PK&#xD;
      studies in healthy animals and critically ill animal models with or without ECMO to define&#xD;
      the PK alterations. Clinical PK studies in critically ill patients on ECMO.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Anticipated">December 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">July 1, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The median observed peak concentration(Cmax)</measure>
    <time_frame>one-dose period</time_frame>
    <description>Using liquid chromatography-mass spectrometry to evaluate the concentration of study drugs</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The median observed through concentration(Cmin)</measure>
    <time_frame>one-dose period</time_frame>
    <description>Using liquid chromatography-mass spectrometry to evaluate the concentration of study drugs</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Volume of distribution(Vd)</measure>
    <time_frame>one-dose period</time_frame>
    <description>PK data were analyzed with a nonlinear mixed-effect modeling approach using NONMEM version 7.2.0</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the plasma concentration versus time curve (AUC)</measure>
    <time_frame>one-dose period</time_frame>
    <description>PK data were analyzed with a nonlinear mixed-effect modeling approach using NONMEM version 7.2.0</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Inter-compartmental clearance (Q)</measure>
    <time_frame>one-dose period</time_frame>
    <description>PK data were analyzed with a nonlinear mixed-effect modeling approach using NONMEM version 7.2.0</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Clearance(CL)</measure>
    <time_frame>one-dose period</time_frame>
    <description>PK data were analyzed with a nonlinear mixed-effect modeling approach using NONMEM version 7.2.0</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Development of strategies for drug administration in critically ill patients receiving ECMO</measure>
    <time_frame>one-dose period</time_frame>
    <description>PK models for study drugs using a non-linear mixed effects modeling approach.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Extracorporeal Membrane Oxygenation</condition>
  <condition>Pharmacokinetics</condition>
  <arm_group>
    <arm_group_label>Animal study</arm_group_label>
    <description>Critically ill animal on ECMO. PK data from critically ill animal on ECMO will be compared with data from controls and healthy animal on ECMO.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Clinical study</arm_group_label>
    <description>To describe variation of plasma concentration of drugs in patients receiving ECMO, as compared with patients without ECMO.And develop population PK model for ECMO patients.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ECMO</intervention_name>
    <description>Extracorporeal membrane oxygenation (ECMO) temporarily supports patients with severe cardio-respiratory failure</description>
    <arm_group_label>Animal study</arm_group_label>
    <arm_group_label>Clinical study</arm_group_label>
    <other_name>Extracorporeal membrane oxygenation</other_name>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood samples drawn from an existing arterial line and collect in 2-4ml tubes. Centrifuged at&#xD;
      3000 rpm for 10 minutes before frozen at -80℃.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who are undergoing ECMO&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who are undergoing ECMO for respiratory and or cardiac dysfunction&#xD;
&#xD;
          -  Clinical indication for the antibiotics&#xD;
&#xD;
          -  Clinical indication for the sedatives and analgesics&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No consent&#xD;
&#xD;
          -  Known allergy to study drug&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Massive fluid resuscitation (&gt;50% blood volume transfused) in the previous 8 hours.&#xD;
&#xD;
          -  Therapeutic plasma exchange in the preceding 24 hours&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chen Wang</last_name>
    <role>Study Chair</role>
    <affiliation>China-Japan Friendship Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Qingyuan Zhan, MD</last_name>
    <phone>13683598417</phone>
    <email>zhanqy0915@163.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Min Li, MD</last_name>
    <phone>13683598417</phone>
    <email>qlyy_limin@163.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>China-Japan Friendship hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100028</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Chen Wang, MD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 4, 2018</study_first_submitted>
  <study_first_submitted_qc>December 5, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 6, 2018</study_first_posted>
  <last_update_submitted>December 5, 2018</last_update_submitted>
  <last_update_submitted_qc>December 5, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 6, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>China-Japan Friendship Hospital</investigator_affiliation>
    <investigator_full_name>Qingyuan Zhan</investigator_full_name>
    <investigator_title>Prof.</investigator_title>
  </responsible_party>
  <keyword>Pharmacokinetics</keyword>
  <keyword>extracorporeal membrane oxygenation</keyword>
  <!-- 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/NCT03766282
org study id: 2017-2-QN-15
nct id: NCT03766282
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The main purpose of the present study is to investigate the risk factors that affect drug
      pharmacokinetic (PK) during extracorporeal membrane oxygenation (ECMO). To advance
      understanding of PK variance and improve the patients outcomes during ECMO.
Ex vivo experiments for drug stability testing and ECMO circuits testing in animal models.PK
      studies in healthy animals and critically ill animal models with or without ECMO to define
      the PK alterations. Clinical PK studies in critically ill patients on ECMO.
observational model: Case-Control
time perspective: Prospective
measure: The median observed peak concentration(Cmax)
time frame: one-dose period
description: Using liquid chromatography-mass spectrometry to evaluate the concentration of study drugs
measure: The median observed through concentration(Cmin)
time frame: one-dose period
description: Using liquid chromatography-mass spectrometry to evaluate the concentration of study drugs
measure: Volume of distribution(Vd)
time frame: one-dose period
description: PK data were analyzed with a nonlinear mixed-effect modeling approach using NONMEM version 7.2.0
measure: Area under the plasma concentration versus time curve (AUC)
time frame: one-dose period
description: PK data were analyzed with a nonlinear mixed-effect modeling approach using NONMEM version 7.2.0
measure: Inter-compartmental clearance (Q)
time frame: one-dose period
description: PK data were analyzed with a nonlinear mixed-effect modeling approach using NONMEM version 7.2.0
measure: Clearance(CL)
time frame: one-dose period
description: PK data were analyzed with a nonlinear mixed-effect modeling approach using NONMEM version 7.2.0
measure: Development of strategies for drug administration in critically ill patients receiving ECMO
time frame: one-dose period
description: PK models for study drugs using a non-linear mixed effects modeling approach.
arm group label: Animal study
description: Critically ill animal on ECMO. PK data from critically ill animal on ECMO will be compared with data from controls and healthy animal on ECMO.
arm group label: Clinical study
description: To describe variation of plasma concentration of drugs in patients receiving ECMO, as compared with patients without ECMO.And develop population PK model for ECMO patients.
intervention type: Device
intervention name: ECMO
description: Extracorporeal membrane oxygenation (ECMO) temporarily supports patients with severe cardio-respiratory failure
arm group label: Animal study
arm group label: Clinical study
other name: Extracorporeal membrane oxygenation
Blood samples drawn from an existing arterial line and collect in 2-4ml tubes. Centrifuged at
      3000 rpm for 10 minutes before frozen at -80℃.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Chen Wang
role: Study Chair
affiliation: China-Japan Friendship Hospital
last name: Qingyuan Zhan, MD
phone: 13683598417
email: zhanqy0915@163.com
last name: Min Li, MD
phone: 13683598417
email: qlyy_limin@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: China-Japan Friendship Hospital
investigator full name: Qingyuan Zhan
investigator title: Prof.