<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/NCT03787550</url>
  </required_header>
  <id_info>
    <org_study_id>ECMO001</org_study_id>
    <nct_id>NCT03787550</nct_id>
  </id_info>
  <brief_title>PK/PD of the Sedatives, Analgesics and Antibiotics in Patients Receiving ECMO</brief_title>
  <official_title>Pharmacokinetics/Pharmacodynamics of the Sedatives, Analgesics and Antibiotics in Patients Receiving Extracorporeal Membrane Oxygenation (ECMO)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Guangdong Provincial People's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Guangdong Provincial People's Hospital</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>
      It is a multi-center, open-label, observational study aimed to understand the&#xD;
      pharmacokinetics and pharmacodynamics of the commonly used sedative, analgesic and antibiotic&#xD;
      drugs in adult patients supported with extracorporeal membrane oxygenation (ECMO), by&#xD;
      measuring the plasma concentrations and the clinical effect of dexmedetomidine, midazolam,&#xD;
      butorphanol, remifentanil, sufentanil, propofol, linezolid, tigecycline, teicoplanin,&#xD;
      caspofungin, voriconazole and meropenem.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">February 7, 2020</start_date>
  <completion_date type="Anticipated">March 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Minimum Plasma Concentration [Cmin]</measure>
    <time_frame>Up to 24 hours.</time_frame>
    <description>The minimum plasma concentration (the trough concentration), usually collected before the next dose.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Area Under the Curve [AUC]</measure>
    <time_frame>Up to 24 hours.</time_frame>
    <description>The area under the curve during the dose interval. It also can be calculated by the dose and the clearance of the drug.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum Plasma Concentration [Cmax]</measure>
    <time_frame>Up to 24 hours.</time_frame>
    <description>The maximum plasma concentration, usually at the end of the infusion during an dose interval.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>ICU mortality</measure>
    <time_frame>Up to 60 days.</time_frame>
    <description>The intensive care unit (ICU) mortality is calculated as the number of deaths of the enrolled patients admitted to the ICU, divided by the number of the enrolled patient discharges from the ICU (including deaths and transfers), and often presented as percentage.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital mortality</measure>
    <time_frame>Up to 60 days.</time_frame>
    <description>The hospital mortality is calculated as the number of deaths of the enrolled patients divided by the number of the total enrolled patient, and often presented as percentage.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mechanical ventilation duration</measure>
    <time_frame>Up to 60 days.</time_frame>
    <description>Mechanical ventilation duration is the length of days the patients on the mechanical ventilation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ICU length of stay (LOS)</measure>
    <time_frame>Up to 60 days.</time_frame>
    <description>ICU length of stay (LOS) is the length of days the patients in the ICU.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">36</enrollment>
  <condition>Drug Effect</condition>
  <arm_group>
    <arm_group_label>Model building group</arm_group_label>
    <description>The data from the patients in the model building group will be used to build the population PK/PD model. Two to six blood samples will be collected during at least one dose interval at the steady-state, including one sample from the start of ECMO and one at the end of ECMO.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Model validation group</arm_group_label>
    <description>The data from the patients in the model building group will be used to build the population PK/PD model. Two to three blood samples will be collected during at least one dose interval at the steady-state, including one sample from the start of ECMO and one at the end of ECMO.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>The Sedatives, analgesics and antibiotics</intervention_name>
    <description>The sedatives (dexmedetomidine, midazolam, propofol), analgesics (butorphanol, remifentanil, sufentanil), and six antibiotics (linezolid, voriconazole, tigecycline, teicoplanin, caspofungin and meropenem) will be used according to the clinical need.</description>
    <arm_group_label>Model building group</arm_group_label>
    <arm_group_label>Model validation group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The patients undergoing ECMO will be invited to participate. At least 2-12 subjects will be&#xD;
        enrolled to build a pharmacokineic model for each drug, and 1-4 subjects for external&#xD;
        validation for each drug. The investigators plan to study the sedatives, analgesics and&#xD;
        antibiotics with the initial sample size at 36 in total.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient given the sedatives, analgesics and antibiotics of interest during ECMO.&#xD;
&#xD;
          -  Age from 18 to 85 years old.&#xD;
&#xD;
          -  Multiple blood sampling is acceptable.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who are allergic to the investigated drugs.&#xD;
&#xD;
          -  Patients who are pregnant.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chunbo Chen, Ph. D.</last_name>
    <role>Study Chair</role>
    <affiliation>Guandong General Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Chunbo Chen, Ph. D.</last_name>
    <phone>+86-20-83827812</phone>
    <phone_ext>51157</phone_ext>
    <email>gghccm@163.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Xipei Wang, Ph. D.</last_name>
    <phone>+86-20-83827812</phone>
    <phone_ext>51157</phone_ext>
    <email>xipei_wang@163.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Guangdong Provincial People's Hospital</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510080</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Chunbo Chen, Ph.D.</last_name>
    </contact>
    <contact_backup>
      <last_name>Xipei Wang, Ph.D.</last_name>
      <email>xipei_wang@163.com</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Guangzhou First People's Hospital</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location>
    <facility>
      <name>Nanfang Hospital</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>November 21, 2018</study_first_submitted>
  <study_first_submitted_qc>December 23, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 26, 2018</study_first_posted>
  <last_update_submitted>February 12, 2020</last_update_submitted>
  <last_update_submitted_qc>February 12, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ECMO</keyword>
  <keyword>Sedatives</keyword>
  <keyword>Analgesics</keyword>
  <keyword>Antibiotics</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anti-Bacterial Agents</mesh_term>
    <mesh_term>Analgesics</mesh_term>
    <mesh_term>Hypnotics and Sedatives</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/NCT03787550
org study id: ECMO001
nct id: NCT03787550
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
It is a multi-center, open-label, observational study aimed to understand the
      pharmacokinetics and pharmacodynamics of the commonly used sedative, analgesic and antibiotic
      drugs in adult patients supported with extracorporeal membrane oxygenation (ECMO), by
      measuring the plasma concentrations and the clinical effect of dexmedetomidine, midazolam,
      butorphanol, remifentanil, sufentanil, propofol, linezolid, tigecycline, teicoplanin,
      caspofungin, voriconazole and meropenem.
observational model: Cohort
time perspective: Prospective
measure: Minimum Plasma Concentration [Cmin]
time frame: Up to 24 hours.
description: The minimum plasma concentration (the trough concentration), usually collected before the next dose.
measure: Area Under the Curve [AUC]
time frame: Up to 24 hours.
description: The area under the curve during the dose interval. It also can be calculated by the dose and the clearance of the drug.
measure: Maximum Plasma Concentration [Cmax]
time frame: Up to 24 hours.
description: The maximum plasma concentration, usually at the end of the infusion during an dose interval.
measure: ICU mortality
time frame: Up to 60 days.
description: The intensive care unit (ICU) mortality is calculated as the number of deaths of the enrolled patients admitted to the ICU, divided by the number of the enrolled patient discharges from the ICU (including deaths and transfers), and often presented as percentage.
measure: Hospital mortality
time frame: Up to 60 days.
description: The hospital mortality is calculated as the number of deaths of the enrolled patients divided by the number of the total enrolled patient, and often presented as percentage.
measure: Mechanical ventilation duration
time frame: Up to 60 days.
description: Mechanical ventilation duration is the length of days the patients on the mechanical ventilation.
measure: ICU length of stay (LOS)
time frame: Up to 60 days.
description: ICU length of stay (LOS) is the length of days the patients in the ICU.
arm group label: Model building group
description: The data from the patients in the model building group will be used to build the population PK/PD model. Two to six blood samples will be collected during at least one dose interval at the steady-state, including one sample from the start of ECMO and one at the end of ECMO.
arm group label: Model validation group
description: The data from the patients in the model building group will be used to build the population PK/PD model. Two to three blood samples will be collected during at least one dose interval at the steady-state, including one sample from the start of ECMO and one at the end of ECMO.
intervention type: Drug
intervention name: The Sedatives, analgesics and antibiotics
description: The sedatives (dexmedetomidine, midazolam, propofol), analgesics (butorphanol, remifentanil, sufentanil), and six antibiotics (linezolid, voriconazole, tigecycline, teicoplanin, caspofungin and meropenem) will be used according to the clinical need.
arm group label: Model building group
arm group label: Model validation group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Chunbo Chen, Ph. D.
role: Study Chair
affiliation: Guandong General Hospital
last name: Chunbo Chen, Ph. D.
phone: +86-20-83827812
phone ext: 51157
email: gghccm@163.com
last name: Xipei Wang, Ph. D.
phone: +86-20-83827812
phone ext: 51157
email: xipei_wang@163.com
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
facility: 
status: Recruiting
country: China
responsible party type: Sponsor
mesh term: Anti-Bacterial Agents
mesh term: Analgesics
mesh term: Hypnotics and Sedatives