<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/NCT02241083</url>
  </required_header>
  <id_info>
    <org_study_id>R05114</org_study_id>
    <nct_id>NCT02241083</nct_id>
  </id_info>
  <brief_title>The Effect of Norepinephrine and Dopamine on Radial Forearm Free Flap Tissue Oxygen Pressure and Microdialysate Metabolite Measurements</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tampere University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tampere University Hospital</source>
  <brief_summary>
    <textblock>
      Vasopressors may be needed after head and neck microvascular reconstructions to maintain&#xD;
      sufficient mean arterial pressure. This is crucial for the flap survival. The study&#xD;
      hypothesis is that norepinephrine and dopamine used as vasopressors do not affect flap tissue&#xD;
      oxygen level and microdialysate metabolites.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2006</start_date>
  <primary_completion_date type="Actual">May 2014</primary_completion_date>
  <phase>Phase 4</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>Evidence of clinically definite ischemia in a flap confirmed by changes in tissue oxygen pressure level and microdialysates metabolites</measure>
    <time_frame>72 hours</time_frame>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Head and Neck Cancer</condition>
  <arm_group>
    <arm_group_label>dopamine group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>vasopressor dosage individually titred according to the mean arterial pressure</description>
  </arm_group>
  <arm_group>
    <arm_group_label>norepinephrine group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>vasopressor dosage individually titred according to the mean arterial pressure</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>no medication</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dopamine</intervention_name>
    <arm_group_label>dopamine group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Norepinephrine</intervention_name>
    <arm_group_label>norepinephrine group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>no medication</intervention_name>
    <arm_group_label>control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  head and neck cancer patients having tumor ablation surgery and reconstruction with&#xD;
             microvascular radial forearm flap&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients having contraindications for the operation.&#xD;
&#xD;
          -  Patient refusal to participate in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Tampere University Hospital</name>
      <address>
        <city>Tampere</city>
        <state>P.O. Box 2000</state>
        <zip>33521</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Finland</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 12, 2014</study_first_submitted>
  <study_first_submitted_qc>September 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 16, 2014</study_first_posted>
  <last_update_submitted>September 15, 2014</last_update_submitted>
  <last_update_submitted_qc>September 15, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 16, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tampere University Hospital</investigator_affiliation>
    <investigator_full_name>Minna Kääriäinen</investigator_full_name>
    <investigator_title>MD, PhD, Senior Consultant, Associate Chief</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Head and Neck Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dopamine</mesh_term>
    <mesh_term>Norepinephrine</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/NCT02241083
org study id: R05114
nct id: NCT02241083
lead sponsor: 
Vasopressors may be needed after head and neck microvascular reconstructions to maintain
      sufficient mean arterial pressure. This is crucial for the flap survival. The study
      hypothesis is that norepinephrine and dopamine used as vasopressors do not affect flap tissue
      oxygen level and microdialysate metabolites.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Evidence of clinically definite ischemia in a flap confirmed by changes in tissue oxygen pressure level and microdialysates metabolites
time frame: 72 hours
arm group label: dopamine group
arm group type: Active Comparator
description: vasopressor dosage individually titred according to the mean arterial pressure
arm group label: norepinephrine group
arm group type: Active Comparator
description: vasopressor dosage individually titred according to the mean arterial pressure
arm group label: control group
arm group type: Active Comparator
description: no medication
intervention type: Drug
intervention name: Dopamine
arm group label: dopamine group
intervention type: Drug
intervention name: Norepinephrine
arm group label: norepinephrine group
intervention type: Other
intervention name: no medication
arm group label: control group
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: Finland
responsible party type: Principal Investigator
investigator affiliation: Tampere University Hospital
investigator full name: Minna Kääriäinen
investigator title: MD, PhD, Senior Consultant, Associate Chief
mesh term: Head and Neck Neoplasms
mesh term: Dopamine
mesh term: Norepinephrine