<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/NCT02990546</url>
  </required_header>
  <id_info>
    <org_study_id>19198</org_study_id>
    <nct_id>NCT02990546</nct_id>
  </id_info>
  <brief_title>Midodrine in the Recovery Phase of Septic Shock</brief_title>
  <official_title>Midodrine Use in the Recovery Phase of Septic Shock</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Virginia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Virginia</source>
  <oversight_info>
    <has_dmc>Yes</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 aim of this study is to investigate the role of oral midodrine in the recovery of septic&#xD;
      shock. The investigators hypothesize that the oral drug can reduce central line days and ICU&#xD;
      length of stay.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators aim to investigate the use of midodrine in the recovery phase of septic&#xD;
      shock in a randomized control trial. The investigators hypothesize that midodrine use&#xD;
      initiated after stabilization or improving intravenous vasopressor requirement will lead to&#xD;
      decreased length of ICU stay and length of time that intravenous vasopressors are required.&#xD;
&#xD;
      The investigators plan to enroll and consent patients at the onset of septic shock. Once IV&#xD;
      vasopressor requirement is stabilized or decreasing, males and females will be randomized in&#xD;
      1:1 fashion to receive either standard clinical care or standard clinical care plus oral&#xD;
      midodrine. The investigators will analyze length of stay in the ICU, time on vasopressors,&#xD;
      time needing a central line, and hospital length of stay.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Unable to meet enrollment goals&#xD;
  </why_stopped>
  <start_date type="Actual">March 1, 2017</start_date>
  <completion_date type="Actual">May 2, 2018</completion_date>
  <primary_completion_date type="Actual">May 2, 2018</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>ICU free days</measure>
    <time_frame>28 days</time_frame>
    <description>ICU free days from first 28 days</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Central venous catheter free days</measure>
    <time_frame>28 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IV vasopressor free days</measure>
    <time_frame>28 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital length of stay</measure>
    <time_frame>up to 90 days</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">4</enrollment>
  <condition>Septic Shock</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In the intervention arm 10 mg of midodrine will be given orally three times daily starting at the time of stable or decreasing intravenous vasopressor support</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The control arm will receive standard of care for septic shock with IV vasopressor support as needed to maintain MAP goal &gt; 65 mmHg</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>midodrine</intervention_name>
    <description>Midodrine will be given to treatment arm as enteral medication</description>
    <arm_group_label>Intervention</arm_group_label>
    <other_name>Midodrine Hydrochloride; Proamatine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard of Care</intervention_name>
    <description>Patients in the control arm will receive standard of care for septic shock</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  • Patients aged 18-99 years old&#xD;
&#xD;
               -  Admitted to UVA medical ICU with diagnosis of septic shock.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant females, patients with childbearing potential will have urine pregnancy&#xD;
             testing after consent&#xD;
&#xD;
          -  Patients &lt; 18 years&#xD;
&#xD;
          -  Prisoners&#xD;
&#xD;
          -  Patients already taking midodrine&#xD;
&#xD;
          -  Patients with cirrhosis and Child-Pugh Class C (Child-Pugh score &gt; 9)_&#xD;
&#xD;
          -  Patients with Increased intraocular pressure and glaucoma&#xD;
&#xD;
          -  Patients with allergy to midodrine&#xD;
&#xD;
          -  Non-English speaking patients&#xD;
&#xD;
          -  Patients without enteral access&#xD;
&#xD;
          -  Patients where the attending physician does not feel MAP goal of &gt; 65 mmHg is&#xD;
             physiologically acceptable.&#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>Robert M Jones, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Virginia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Virginia</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22908</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>November 16, 2016</study_first_submitted>
  <study_first_submitted_qc>December 12, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 13, 2016</study_first_posted>
  <last_update_submitted>May 2, 2018</last_update_submitted>
  <last_update_submitted_qc>May 2, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 8, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Virginia</investigator_affiliation>
    <investigator_full_name>Robert Jones, MD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Shock, Septic</mesh_term>
    <mesh_term>Shock</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Midodrine</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/NCT02990546
org study id: 19198
nct id: NCT02990546
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
The aim of this study is to investigate the role of oral midodrine in the recovery of septic
      shock. The investigators hypothesize that the oral drug can reduce central line days and ICU
      length of stay.
The investigators aim to investigate the use of midodrine in the recovery phase of septic
      shock in a randomized control trial. The investigators hypothesize that midodrine use
      initiated after stabilization or improving intravenous vasopressor requirement will lead to
      decreased length of ICU stay and length of time that intravenous vasopressors are required.

      The investigators plan to enroll and consent patients at the onset of septic shock. Once IV
      vasopressor requirement is stabilized or decreasing, males and females will be randomized in
      1:1 fashion to receive either standard clinical care or standard clinical care plus oral
      midodrine. The investigators will analyze length of stay in the ICU, time on vasopressors,
      time needing a central line, and hospital length of stay.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: ICU free days
time frame: 28 days
description: ICU free days from first 28 days
measure: Central venous catheter free days
time frame: 28 days
measure: IV vasopressor free days
time frame: 28 days
measure: Hospital length of stay
time frame: up to 90 days
arm group label: Intervention
arm group type: Experimental
description: In the intervention arm 10 mg of midodrine will be given orally three times daily starting at the time of stable or decreasing intravenous vasopressor support
arm group label: Control
arm group type: Other
description: The control arm will receive standard of care for septic shock with IV vasopressor support as needed to maintain MAP goal > 65 mmHg
intervention type: Drug
intervention name: midodrine
description: Midodrine will be given to treatment arm as enteral medication
arm group label: Intervention
other name: Midodrine Hydrochloride; Proamatine
intervention type: Other
intervention name: Standard of Care
description: Patients in the control arm will receive standard of care for septic shock
arm group label: Control
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Robert M Jones, MD
role: Principal Investigator
affiliation: University of Virginia
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Virginia
investigator full name: Robert Jones, MD
investigator title: Principal Investigator
mesh term: Shock, Septic
mesh term: Shock
mesh term: Midodrine
sharing ipd: No