<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/NCT01707953</url>
  </required_header>
  <id_info>
    <org_study_id>RH-4074-OJ1</org_study_id>
    <secondary_id>2012-002572-13</secondary_id>
    <nct_id>NCT01707953</nct_id>
  </id_info>
  <brief_title>Efficacy of Midodrine for the Prevention of Orthostatic Hypotension During Early Mobilization After Fast-track Hip Arthroplasty</brief_title>
  <official_title>Efficacy of Midodrine for the Prevention of Orthostatic Hypotension During Early Mobilization After Fast-track Hip Arthroplasty - a Randomized, Placebo Controlled Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rigshospitalet, Denmark</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rigshospitalet, Denmark</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to examine the efficacy of 5 mg Midodrine (Gutron) vs. placebo on&#xD;
      reducing the incidence of orthostatic hypotension during mobilization 6 h after a total hip&#xD;
      arthroplasty.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">September 2013</completion_date>
  <primary_completion_date type="Actual">September 2013</primary_completion_date>
  <phase>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>Prevention</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Orthostatic hypotension</measure>
    <time_frame>6 hours after surgery</time_frame>
    <description>Orthostatic hypotension (OH) during early mobilization 6 hours after end of surgery. OH is classified according to international consensus.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Orthostatic hypotension 24 hours after surgery</measure>
    <time_frame>24 hours after end of surgery.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Orthostatic Intolerance</measure>
    <time_frame>6 and 24 hours after end of surgery</time_frame>
    <description>Orthostatic intolerance is defined as subjective presyncopal symptoms (dizziness, nausea etc.) during mobilization after surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment side effects</measure>
    <time_frame>6 and 24 hours after end of surgery</time_frame>
    <description>The following side effects to Midodrine are evaluated:&#xD;
Pruritus&#xD;
Headache&#xD;
Supine hypertension&#xD;
Urinary retention</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Haemodynamic response to mobilization 6 and 24 hours after surgery</measure>
    <time_frame>6 and 24 hours after end of surgery</time_frame>
    <description>Haemodynamic response to mobilization (supine, sitting and standing):&#xD;
Response in systolic and diastolic blood pressure&#xD;
Response in heart rate.&#xD;
Response in calculated haemodynamic variables (stroke volume, peripheral resistance)</description>
  </other_outcome>
  <other_outcome>
    <measure>Heart rate variability</measure>
    <time_frame>before surgery, 6- and 24 hours after surgery</time_frame>
    <description>Heart rate variability measures including spectral analysis and LF/HF ratio at rest and during mobilization.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Postoperative Orthostatic Hypotension</condition>
  <condition>Postoperative Orthostatic Intolerance</condition>
  <arm_group>
    <arm_group_label>Midodrine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Midodrine Hydrochloride (5mg) administered as capsule 5 and 23 hours after end of surgery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo administered as capsule 5- and 23 hours after end of surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Midodrine</intervention_name>
    <description>Midodrine 5mg as capsule, administered twice (5 and 23 hours after end of surgery).</description>
    <arm_group_label>Midodrine</arm_group_label>
    <other_name>Gutron</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo capsule to mimic midodrine</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Scheduled for primary unilateral hip arthroplasty&#xD;
&#xD;
          -  Age &gt;= 18 years&#xD;
&#xD;
          -  Able to give informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  General anaesthesia for the current procedure&#xD;
&#xD;
          -  Digoxin treatment.&#xD;
&#xD;
          -  history of renal or hepatic failure&#xD;
&#xD;
          -  history of glaucoma&#xD;
&#xD;
          -  history chronic urinary retention requiring treatment&#xD;
&#xD;
          -  history of orthostatic intolerance / hypotension&#xD;
&#xD;
          -  other autonomous nervous system disease&#xD;
&#xD;
          -  alcohol or drug abuse&#xD;
&#xD;
          -  current malignant disease&#xD;
&#xD;
          -  females in the fertile age (possible pregnancy or breast feeding)&#xD;
&#xD;
          -  Treatment with anticoagulants&#xD;
&#xD;
          -  BMI &gt; 40 kg/m2&#xD;
&#xD;
          -  Dementia or cognitive dysfunction (investigators evaluation)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Henrik Kehlet, Proffessor</last_name>
    <role>Study Chair</role>
    <affiliation>Rigshospitalet, Section for Surgical Pathophysiology</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Oeivind Jans, M.D.</last_name>
    <role>Study Director</role>
    <affiliation>Rigshospitalet, Section for Surgical Pathophysiology</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Gentofte Hospital, Department of orthopaedic surgery</name>
      <address>
        <city>Hellerup</city>
        <zip>2900</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hvidovre Hospital, Department of orthopaedic surgery</name>
      <address>
        <city>Hvidovre</city>
        <zip>2650</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vejle Sygehus, Department of orthopedic surgery</name>
      <address>
        <city>Vejle</city>
        <zip>7100</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>January 2014</verification_date>
  <study_first_submitted>October 10, 2012</study_first_submitted>
  <study_first_submitted_qc>October 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 16, 2012</study_first_posted>
  <last_update_submitted>January 17, 2014</last_update_submitted>
  <last_update_submitted_qc>January 17, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 20, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rigshospitalet, Denmark</investigator_affiliation>
    <investigator_full_name>Oeivind Jans</investigator_full_name>
    <investigator_title>M.D, Research Fellow</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypotension, Orthostatic</mesh_term>
    <mesh_term>Orthostatic Intolerance</mesh_term>
    <mesh_term>Hypotension</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Midodrine</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/NCT01707953
org study id: RH-4074-OJ1
secondary id: 2012-002572-13
nct id: NCT01707953
lead sponsor: 
has dmc: Yes
The aim of this study is to examine the efficacy of 5 mg Midodrine (Gutron) vs. placebo on
      reducing the incidence of orthostatic hypotension during mobilization 6 h after a total hip
      arthroplasty.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Orthostatic hypotension
time frame: 6 hours after surgery
description: Orthostatic hypotension (OH) during early mobilization 6 hours after end of surgery. OH is classified according to international consensus.
measure: Orthostatic hypotension 24 hours after surgery
time frame: 24 hours after end of surgery.
measure: Orthostatic Intolerance
time frame: 6 and 24 hours after end of surgery
description: Orthostatic intolerance is defined as subjective presyncopal symptoms (dizziness, nausea etc.) during mobilization after surgery
measure: Treatment side effects
time frame: 6 and 24 hours after end of surgery
description: The following side effects to Midodrine are evaluated:
Pruritus
Headache
Supine hypertension
Urinary retention
measure: Haemodynamic response to mobilization 6 and 24 hours after surgery
time frame: 6 and 24 hours after end of surgery
description: Haemodynamic response to mobilization (supine, sitting and standing):
Response in systolic and diastolic blood pressure
Response in heart rate.
Response in calculated haemodynamic variables (stroke volume, peripheral resistance)
measure: Heart rate variability
time frame: before surgery, 6- and 24 hours after surgery
description: Heart rate variability measures including spectral analysis and LF/HF ratio at rest and during mobilization.
arm group label: Midodrine
arm group type: Experimental
description: Midodrine Hydrochloride (5mg) administered as capsule 5 and 23 hours after end of surgery.
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo administered as capsule 5- and 23 hours after end of surgery.
intervention type: Drug
intervention name: Midodrine
description: Midodrine 5mg as capsule, administered twice (5 and 23 hours after end of surgery).
arm group label: Midodrine
other name: Gutron
intervention type: Drug
intervention name: Placebo
description: Placebo capsule to mimic midodrine
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Henrik Kehlet, Proffessor
role: Study Chair
affiliation: Rigshospitalet, Section for Surgical Pathophysiology
last name: Oeivind Jans, M.D.
role: Study Director
affiliation: Rigshospitalet, Section for Surgical Pathophysiology
facility: 
facility: 
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Rigshospitalet, Denmark
investigator full name: Oeivind Jans
investigator title: M.D, Research Fellow
mesh term: Hypotension, Orthostatic
mesh term: Orthostatic Intolerance
mesh term: Hypotension
mesh term: Midodrine