<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/NCT01664520</url>
  </required_header>
  <id_info>
    <org_study_id>Turku University Hospital</org_study_id>
    <secondary_id>2012-000068-11</secondary_id>
    <secondary_id>KLNRO 45/2012</secondary_id>
    <nct_id>NCT01664520</nct_id>
  </id_info>
  <brief_title>Dexmedetomidine and Subarachnoid Haemorrhage</brief_title>
  <official_title>The Effects of Dexmedetomidine on Cerebral Autoregulation and Cerebral Oxygenation in Subarachnoid Haemorrhage Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Turku University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Orion Corporation, Orion Pharma</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Turku University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to investigate how dexmedetomidine affects static and dynamic&#xD;
      autoregulation, intracranial pressure (ICP) and cerebral oxygenation in aneurysmal&#xD;
      subarachnoid haemorrhage (SAH) patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Dexmedetomidine is a selective α2-agonist which induces sedation, anxiolysis and analgesia&#xD;
      without respiratory depression. These effects, as well as neuroprotective properties in&#xD;
      experimental studies would be ideal in neuroanaesthesia and in neurocritical care. Poor grade&#xD;
      SAH patients are treated in intensive care units (ICU). These patients are sedated often with&#xD;
      propofol. However, to assess the patient's neurology, the propofol sedation must be stopped&#xD;
      and the wakening of the patient may take time. Dexmedetomidine would be more advantageous,&#xD;
      allowing wakening during the infusion. However, the effects of dexmedetomidine on cerebral&#xD;
      autoregulation are unknown in SAH patients.&#xD;
&#xD;
      15 SAH patients requiring sedation, mechanical ventilation and ICP monitoring will be rolled&#xD;
      in to the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2013</start_date>
  <completion_date type="Actual">December 30, 2016</completion_date>
  <primary_completion_date type="Actual">November 30, 2016</primary_completion_date>
  <phase>Phase 1/Phase 2</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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in autoregulation, ICP and cerebral oxygenation</measure>
    <time_frame>2, 4 and 6 hours</time_frame>
    <description>Autoregulation is assessed using transcranial doppler (TCD) and ICP amplitude analysis. ICP and cerebral oxygenation are part of standard multimodal monitoring and these are continuously monitored and recorded.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Subarachnoid Hemorrhage</condition>
  <condition>Aneurysm</condition>
  <arm_group>
    <arm_group_label>Dexmedetomine infusion</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexmedetomidine infusion</intervention_name>
    <description>Both static and dynamic autoregulation are assessed first during propofol infusion, before commencement of dexmedetomidine infusion. Dexmedetomidine infusion is commenced with a dose of 0.7 μg/kg/h and propofol infusion is stopped concomitantly. After 2 hours dexmedetomidine infusion, the static and dynamic autoregulation are assessed. If there are no signs of worsening of autoregulation, then the dexmedetomidine infusion is increased to 1 μg/kg/h and after 2 hours the static and dynamic autoregulation are assessed again. However, if autoregulation worsens during dexmedetomidine infusion, it will be stopped and further testing with dexmedetomidine will not be carried out. If autoregulation does not worsen with the 1 μg/kg/h dose then the dose will be increased to 1.4 μg/kg/h. After 2 hours infusion the dynamic and static autoregulation are assessed again.&#xD;
Blood samples for determining dexmedetomidine plasma concentration are collected alongside with the autoregulation assessments</description>
    <arm_group_label>Dexmedetomine infusion</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aneurysmal SAH&#xD;
&#xD;
          -  Aneurysm treated with coil(s) or clip(s)&#xD;
&#xD;
          -  Age 18-80 years&#xD;
&#xD;
          -  Written informed consent from the next of kin&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Nursing woman&#xD;
&#xD;
          -  Sick sinus syndrome&#xD;
&#xD;
          -  Carotid stenosis&#xD;
&#xD;
          -  Heart rate less than 50 beats / minute&#xD;
&#xD;
          -  Mean arterial pressure less than 50 mmHg&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Riikka SK Takala, MD PhD</last_name>
    <role>Study Director</role>
    <affiliation>Turku University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Turku University Hospital</name>
      <address>
        <city>Turku</city>
        <zip>20520</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Finland</country>
  </location_countries>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>August 4, 2012</study_first_submitted>
  <study_first_submitted_qc>August 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 14, 2012</study_first_posted>
  <last_update_submitted>February 3, 2017</last_update_submitted>
  <last_update_submitted_qc>February 3, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Turku University Hospital</investigator_affiliation>
    <investigator_full_name>Riikka Takala</investigator_full_name>
    <investigator_title>MD, PhD Senior Staff Anaesthesiologist</investigator_title>
  </responsible_party>
  <keyword>Subarachnoid hemorrhage</keyword>
  <keyword>Dexmedetomidine</keyword>
  <keyword>Autoregulation</keyword>
  <keyword>Intracranial pressure</keyword>
  <keyword>Cerebral oxygenation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Subarachnoid Hemorrhage</mesh_term>
    <mesh_term>Aneurysm</mesh_term>
    <mesh_term>Hemorrhage</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT01664520
org study id: Turku University Hospital
secondary id: 2012-000068-11
secondary id: KLNRO 45/2012
nct id: NCT01664520
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to investigate how dexmedetomidine affects static and dynamic
      autoregulation, intracranial pressure (ICP) and cerebral oxygenation in aneurysmal
      subarachnoid haemorrhage (SAH) patients.
Dexmedetomidine is a selective α2-agonist which induces sedation, anxiolysis and analgesia
      without respiratory depression. These effects, as well as neuroprotective properties in
      experimental studies would be ideal in neuroanaesthesia and in neurocritical care. Poor grade
      SAH patients are treated in intensive care units (ICU). These patients are sedated often with
      propofol. However, to assess the patient's neurology, the propofol sedation must be stopped
      and the wakening of the patient may take time. Dexmedetomidine would be more advantageous,
      allowing wakening during the infusion. However, the effects of dexmedetomidine on cerebral
      autoregulation are unknown in SAH patients.

      15 SAH patients requiring sedation, mechanical ventilation and ICP monitoring will be rolled
      in to the study.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Change in autoregulation, ICP and cerebral oxygenation
time frame: 2, 4 and 6 hours
description: Autoregulation is assessed using transcranial doppler (TCD) and ICP amplitude analysis. ICP and cerebral oxygenation are part of standard multimodal monitoring and these are continuously monitored and recorded.
arm group label: Dexmedetomine infusion
arm group type: Experimental
intervention type: Drug
intervention name: Dexmedetomidine infusion
description: Both static and dynamic autoregulation are assessed first during propofol infusion, before commencement of dexmedetomidine infusion. Dexmedetomidine infusion is commenced with a dose of 0.7 μg/kg/h and propofol infusion is stopped concomitantly. After 2 hours dexmedetomidine infusion, the static and dynamic autoregulation are assessed. If there are no signs of worsening of autoregulation, then the dexmedetomidine infusion is increased to 1 μg/kg/h and after 2 hours the static and dynamic autoregulation are assessed again. However, if autoregulation worsens during dexmedetomidine infusion, it will be stopped and further testing with dexmedetomidine will not be carried out. If autoregulation does not worsen with the 1 μg/kg/h dose then the dose will be increased to 1.4 μg/kg/h. After 2 hours infusion the dynamic and static autoregulation are assessed again.
Blood samples for determining dexmedetomidine plasma concentration are collected alongside with the autoregulation assessments
arm group label: Dexmedetomine infusion
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Riikka SK Takala, MD PhD
role: Study Director
affiliation: Turku University Hospital
facility: 
country: Finland
responsible party type: Principal Investigator
investigator affiliation: Turku University Hospital
investigator full name: Riikka Takala
investigator title: MD, PhD Senior Staff Anaesthesiologist
mesh term: Subarachnoid Hemorrhage
mesh term: Aneurysm
mesh term: Hemorrhage
mesh term: Dexmedetomidine