<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/NCT03293927</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00084476</org_study_id>
    <nct_id>NCT03293927</nct_id>
  </id_info>
  <brief_title>Polypharmacy-related Adverse Events in Critically Ill Children</brief_title>
  <official_title>Investigating Polypharmacy-related Adverse Events in Critically Ill Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Duke University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to learn how 2 medications (fentanyl and dexmedetomidine) affect&#xD;
      how sick children think and interact with their environments.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    No participants enrolled in study.&#xD;
  </why_stopped>
  <start_date type="Actual">April 9, 2018</start_date>
  <completion_date type="Anticipated">July 1, 2019</completion_date>
  <primary_completion_date type="Anticipated">July 1, 2019</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in delirium scores as measured by CAPD score</measure>
    <time_frame>up to 10 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Drug level associated with CAPD score</measure>
    <time_frame>up to 10 days</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Delirium</condition>
  <arm_group>
    <arm_group_label>Fentanyl + Dexmedetomidine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Dexmedetomidine + Fentanyl</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Fentanyl only</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Dexmedetomidine only</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fentanyl</intervention_name>
    <description>The patient will receive IV fentanyl</description>
    <arm_group_label>Dexmedetomidine + Fentanyl</arm_group_label>
    <arm_group_label>Fentanyl + Dexmedetomidine</arm_group_label>
    <arm_group_label>Fentanyl only</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexmedetomidine</intervention_name>
    <description>The patient will receive IV dexemedetomidine</description>
    <arm_group_label>Dexmedetomidine + Fentanyl</arm_group_label>
    <arm_group_label>Dexmedetomidine only</arm_group_label>
    <arm_group_label>Fentanyl + Dexmedetomidine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ages 2-&lt;18 at the time of enrollment&#xD;
&#xD;
          -  Admitted to the Duke PICU or PCICU&#xD;
&#xD;
          -  Planned or anticipated mechanically ventilation for ≥2 days&#xD;
&#xD;
          -  Require sedation to maintain mechanical ventilation&#xD;
&#xD;
          -  No contraindication to receipt of fentanyl or dexmedetomidine per clinician judgment&#xD;
&#xD;
          -  Availability and willingness of the parent/legal guardian to provide written informed&#xD;
             consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any concomitant condition, which in the opinion of the investigator would preclude a&#xD;
             subject's participation in the study.&#xD;
&#xD;
          -  Previous participation in this study&#xD;
&#xD;
          -  Planned receipt of sedatives other than fentanyl or dexmedetomidine&#xD;
&#xD;
          -  Participants with any of the following diagnoses: traumatic brain injury, intracranial&#xD;
             hemorrhage, baseline neurodevelopmental delay, status epilepticus, or requiring&#xD;
             inotropic support for hemodynamic stability.&#xD;
&#xD;
          -  Renal failure requiring renal replacement therapy&#xD;
&#xD;
          -  Hepatic failure&#xD;
&#xD;
          -  Support with extracorporeal membrane oxygenation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kanecia Zimmerman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Duke University Medical Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2018</verification_date>
  <study_first_submitted>September 21, 2017</study_first_submitted>
  <study_first_submitted_qc>September 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 26, 2017</study_first_posted>
  <last_update_submitted>July 16, 2019</last_update_submitted>
  <last_update_submitted_qc>July 16, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 18, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>children, mechanically ventilated, fentanyl, dexmedetomidine, delirium, polypharmacy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Delirium</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fentanyl</mesh_term>
    <mesh_term>Dexmedetomidine</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/NCT03293927
org study id: Pro00084476
nct id: NCT03293927
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
The purpose of this study is to learn how 2 medications (fentanyl and dexmedetomidine) affect
      how sick children think and interact with their environments.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in delirium scores as measured by CAPD score
time frame: up to 10 days
measure: Drug level associated with CAPD score
time frame: up to 10 days
arm group label: Fentanyl + Dexmedetomidine
arm group type: Experimental
arm group label: Dexmedetomidine + Fentanyl
arm group type: Experimental
arm group label: Fentanyl only
arm group type: Experimental
arm group label: Dexmedetomidine only
arm group type: Experimental
intervention type: Drug
intervention name: Fentanyl
description: The patient will receive IV fentanyl
arm group label: Dexmedetomidine + Fentanyl
arm group label: Fentanyl + Dexmedetomidine
arm group label: Fentanyl only
intervention type: Drug
intervention name: Dexmedetomidine
description: The patient will receive IV dexemedetomidine
arm group label: Dexmedetomidine + Fentanyl
arm group label: Dexmedetomidine only
arm group label: Fentanyl + Dexmedetomidine
criteria: 
gender: All
minimum age: 2 Years
maximum age: 17 Years
healthy volunteers: No
last name: Kanecia Zimmerman, MD
role: Principal Investigator
affiliation: Duke
facility: 
country: United States
responsible party type: Sponsor
mesh term: Delirium
mesh term: Fentanyl
mesh term: Dexmedetomidine