<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/NCT02996058</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00008718/00436</org_study_id>
    <nct_id>NCT02996058</nct_id>
  </id_info>
  <brief_title>Safety And Efficacy Of Dexmedetomidine Sedation In Intubated Mechanically Ventilated Infants With Respiratory Failure</brief_title>
  <acronym>DEXinPICU</acronym>
  <official_title>Dexmedetomidine Sedation in Pediatric Intensive Care Unit</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Dexmedetomidine is a highly selective α2-agonist with hypnotic, analgesic, and anxiolytic&#xD;
      properties. Despite off-label administration, dexmedetomidine has found a niche in critically&#xD;
      ill mechanically ventilated neonates and infants because of its minimal effects on&#xD;
      respiratory function at sedative doses, facilitating early extubation and fast-track&#xD;
      postoperative care.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Critically ill children require sedation for comfort and to facilitate mechanical ventilation&#xD;
      and interventions. The ideal sedative agent for use in critically ill children has to be&#xD;
      effective and short-acting, of rapid onset of action, lacks active metabolites, does not&#xD;
      accumulate in patients with renal or hepatic dysfunction, has minimal to no cardiovascular or&#xD;
      respiratory adverse effects, and has few drug interactions.&#xD;
&#xD;
      Dexmedetomidine is a highly selective α2-agonist with hypnotic, analgesic, and anxiolytic&#xD;
      properties. Despite off-label administration, dexmedetomidine has found a niche in critically&#xD;
      ill mechanically ventilated neonates and infants because of its minimal effects on&#xD;
      respiratory function at sedative doses, facilitating early extubation and fast-track&#xD;
      postoperative care.&#xD;
&#xD;
      The only FDA approved indication of dexmedetomidine is sedation of intubated mechanically&#xD;
      ventilated adults for less than 24h. However, the literature is full of many research studies&#xD;
      that investigated the use off-lable use of dexmedetomidine for sedation more than 24h in both&#xD;
      adult and pediatric population and proved its safety and effectiveness.&#xD;
&#xD;
      The aim of this study will be to investigate the safety and efficacy of dexmedetomidine in&#xD;
      two different doses in sedation for critically ill mechanically ventilated infants with&#xD;
      respiratory failure for 72h duration.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2016</start_date>
  <completion_date type="Actual">July 2018</completion_date>
  <primary_completion_date type="Actual">March 2018</primary_completion_date>
  <phase>Phase 2/Phase 3</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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>University of Michigan sedation scale</measure>
    <time_frame>72H</time_frame>
    <description>The university of Michigan sedation scale (UMSS) will be assessed every hour</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The blood pressure</measure>
    <time_frame>72h</time_frame>
    <description>The invasive arterial blood pressure will be recorded every hour</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The heart rate</measure>
    <time_frame>72h</time_frame>
    <description>The heart rate will be recorded every hour.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Sedation</condition>
  <arm_group>
    <arm_group_label>DEX I 0.35µg/kg /h</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>the infants will receive a maintenance dose of 0.35µg/kg /h of Dexmedetomidne without a loading dose and guided by the assessed sedation scale</description>
  </arm_group>
  <arm_group>
    <arm_group_label>DEX II 0.5µg/kg /h</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>the infants will receive a maintenance dose of 0.5µg/kg /h of Dexmedetomidne without a loading dose and guided by the assessed sedation scale.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexmedetomidine 0.35µg/kg /h</intervention_name>
    <description>the infants will receive a maintenance dose of 0.35µg/kg /h of Dexmedetomidne without a loading dose and guided by the assessed sedation scale</description>
    <arm_group_label>DEX I 0.35µg/kg /h</arm_group_label>
    <other_name>Precedex</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexmedetomidine 0.5µg/kg /h</intervention_name>
    <description>the infants will receive a maintenance dose of 0.5µg/kg /h of Dexmedetomidne without a loading dose and guided by the assessed sedation scale</description>
    <arm_group_label>DEX II 0.5µg/kg /h</arm_group_label>
    <other_name>Precedex</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Infants (1-12 months).&#xD;
&#xD;
          -  Respiratory failure/&#xD;
&#xD;
          -  Requiring PICU admission and mechanical ventilation up to 72h.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Significant renal, hepatic, endocrine or metabolic disease.&#xD;
&#xD;
          -  2nd or 3rd degree heart block.&#xD;
&#xD;
          -  hypotension or bradycardia (defined as any value outside the normal range from the&#xD;
             patient's age).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Month</minimum_age>
    <maximum_age>12 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hala S Abdel-Ghaffar, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assisstant professor in anesthesia and intensive care, faculty of medicine, Assiut university, Egypt</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Pediatric hospital</name>
      <address>
        <city>Assiut</city>
        <state>Assiut Governorate</state>
        <zip>715715</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>December 15, 2016</study_first_submitted>
  <study_first_submitted_qc>December 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 19, 2016</study_first_posted>
  <last_update_submitted>July 1, 2018</last_update_submitted>
  <last_update_submitted_qc>July 1, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 3, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Hala Saad Abdel-Ghaffar</investigator_full_name>
    <investigator_title>Assisstant professor in anesthesia and intensive care, Faculty of medicine, Assiut university, Egypt.</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexmedetomidine</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/NCT02996058
org study id: IRB00008718/00436
nct id: NCT02996058
lead sponsor: 
has dmc: Yes
Dexmedetomidine is a highly selective α2-agonist with hypnotic, analgesic, and anxiolytic
      properties. Despite off-label administration, dexmedetomidine has found a niche in critically
      ill mechanically ventilated neonates and infants because of its minimal effects on
      respiratory function at sedative doses, facilitating early extubation and fast-track
      postoperative care.
Critically ill children require sedation for comfort and to facilitate mechanical ventilation
      and interventions. The ideal sedative agent for use in critically ill children has to be
      effective and short-acting, of rapid onset of action, lacks active metabolites, does not
      accumulate in patients with renal or hepatic dysfunction, has minimal to no cardiovascular or
      respiratory adverse effects, and has few drug interactions.

      Dexmedetomidine is a highly selective α2-agonist with hypnotic, analgesic, and anxiolytic
      properties. Despite off-label administration, dexmedetomidine has found a niche in critically
      ill mechanically ventilated neonates and infants because of its minimal effects on
      respiratory function at sedative doses, facilitating early extubation and fast-track
      postoperative care.

      The only FDA approved indication of dexmedetomidine is sedation of intubated mechanically
      ventilated adults for less than 24h. However, the literature is full of many research studies
      that investigated the use off-lable use of dexmedetomidine for sedation more than 24h in both
      adult and pediatric population and proved its safety and effectiveness.

      The aim of this study will be to investigate the safety and efficacy of dexmedetomidine in
      two different doses in sedation for critically ill mechanically ventilated infants with
      respiratory failure for 72h duration.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: University of Michigan sedation scale
time frame: 72H
description: The university of Michigan sedation scale (UMSS) will be assessed every hour
measure: The blood pressure
time frame: 72h
description: The invasive arterial blood pressure will be recorded every hour
measure: The heart rate
time frame: 72h
description: The heart rate will be recorded every hour.
arm group label: DEX I 0.35µg/kg /h
arm group type: Active Comparator
description: the infants will receive a maintenance dose of 0.35µg/kg /h of Dexmedetomidne without a loading dose and guided by the assessed sedation scale
arm group label: DEX II 0.5µg/kg /h
arm group type: Active Comparator
description: the infants will receive a maintenance dose of 0.5µg/kg /h of Dexmedetomidne without a loading dose and guided by the assessed sedation scale.
intervention type: Drug
intervention name: Dexmedetomidine 0.35µg/kg /h
description: the infants will receive a maintenance dose of 0.35µg/kg /h of Dexmedetomidne without a loading dose and guided by the assessed sedation scale
arm group label: DEX I 0.35µg/kg /h
other name: Precedex
intervention type: Drug
intervention name: Dexmedetomidine 0.5µg/kg /h
description: the infants will receive a maintenance dose of 0.5µg/kg /h of Dexmedetomidne without a loading dose and guided by the assessed sedation scale
arm group label: DEX II 0.5µg/kg /h
other name: Precedex
criteria: 
gender: All
minimum age: 1 Month
maximum age: 12 Months
healthy volunteers: No
last name: Hala S Abdel-Ghaffar, MD
role: Principal Investigator
affiliation: Assisstant professor in anesthesia and intensive care, faculty of medicine, Assiut university, Egypt
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Hala Saad Abdel-Ghaffar
investigator title: Assisstant professor in anesthesia and intensive care, Faculty of medicine, Assiut university, Egypt.
mesh term: Dexmedetomidine
sharing ipd: No