<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/NCT03296891</url>
  </required_header>
  <id_info>
    <org_study_id>109038</org_study_id>
    <nct_id>NCT03296891</nct_id>
  </id_info>
  <brief_title>Point of Care Ultrasonography In The Management of Shock: A Pilot Study</brief_title>
  <official_title>Randomized Point of Care Ultrasound Guided Resuscitation and Usual Care Comparison in the Management of Undifferentiated Shock: a Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Western University, Canada</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Western University, Canada</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This project aims to determine the feasibility of conducting a randomized controlled trial&#xD;
      investigating point of care ultrasound guided resuscitation compared with usual care in the&#xD;
      management of shock at the Critical Care Trauma Centre (CCTC) in London Health Science Centre&#xD;
      (LHSC).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 10, 2017</start_date>
  <completion_date type="Actual">November 7, 2020</completion_date>
  <primary_completion_date type="Actual">November 7, 2020</primary_completion_date>
  <phase>N/A</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>Recruitment rate</measure>
    <time_frame>averaged over 48 week period (active recruitment taking place in 48 of those 52 weeks)</time_frame>
    <description>Number of patients who were successfully enrolled in the study per given week.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>28 days</time_frame>
    <description>proportion of patients who are deceased for any reason at 28 days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Successful randomization rate</measure>
    <time_frame>28 days</time_frame>
    <description>proportion of eligible patients who were randomized within the window for enrolment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Protocol adherence rate</measure>
    <time_frame>28 days</time_frame>
    <description>Proportion of participants in the intervention arm that received the intended intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Contamination rate</measure>
    <time_frame>28 days</time_frame>
    <description>Proportion of participants who were randomized to the control arm and inadvertently received the intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Revoked deferred consent rate</measure>
    <time_frame>28 days</time_frame>
    <description>Proportion of participants whose consent was revoked</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ICU length of stay</measure>
    <time_frame>28 days</time_frame>
    <description>total days spent in ICU from time of admission to time of patient discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ventilator free days</measure>
    <time_frame>28 days</time_frame>
    <description>Days alive and free of mechanical ventilation at 28 days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Continuous renal replacement therapy free days</measure>
    <time_frame>28 days</time_frame>
    <description>Days alive and free of vasoactive medications at 28 days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vasoactive medication free days</measure>
    <time_frame>28 days</time_frame>
    <description>Days alive and free of vasoactive medications at 28 days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cumulative fluid balance</measure>
    <time_frame>7 days</time_frame>
    <description>Fluid balance at 7 days post ICU admission or at time of discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acute Kidney Injury (AKIN) stage</measure>
    <time_frame>7 days</time_frame>
    <description>AKIN stage at 7 days post ICU admission or at time of discharge</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Shock</condition>
  <condition>Hypotension</condition>
  <arm_group>
    <arm_group_label>PoCUS Guided Resuscitation of Shock</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants randomized to this arm of the study will undergo PoCUS guided resuscitation of shock.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants randomized to the 'usual care' arm of the study will be suggested to have the following guide resuscitation: 1) Pulse pressure variation (PPV), stroke volume variation (SVV) and/or systolic pressure variation (SPV) on their arterial line, 2) central venous pressure (CVP) and oxygen saturation(ScvO2) measurement, 3) Passive leg raise (PLR) maneuver, and/or 4) pulmonary artery catheter</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>PoCUS Guided Resuscitation of Shock</intervention_name>
    <description>Point-of-care ultrasound (PoCUS) will be used to guide resuscitation of the participant with shock. A PoCUS study will consist of limited echocardiography (LE) and thoracic ultrasound (TUS).</description>
    <arm_group_label>PoCUS Guided Resuscitation of Shock</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients deemed by the clinician to be in shock for any reason and has 3 out of 4 of the&#xD;
        following:&#xD;
&#xD;
          1. Lactate greater than or equal to 2.2 mmol/L&#xD;
&#xD;
          2. AKIN stage I or greater or Urine output less than 0.5 cc/hr&#xD;
&#xD;
          3. Altered level of consciousness due to shock or requiring invasive mechanical&#xD;
             ventilation as a result of shock&#xD;
&#xD;
          4. Vasoactive agents required to maintain a mean arterial pressure greater than 65 mmHg.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnant patients&#xD;
&#xD;
          2. Participants who have already undergone a PoCUS study (as defined in the protocol for&#xD;
             this study) within the past 48 hours&#xD;
&#xD;
          3. Participants who have restrictions on their goals of care at the time of ICU admission&#xD;
             (including patients refusing blood products).&#xD;
&#xD;
          4. Patients post cardiac arrest who are not obeying commands&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>London Health Science Center - Critical Care Trauma Center</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A5W9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 25, 2017</study_first_submitted>
  <study_first_submitted_qc>September 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 28, 2017</study_first_posted>
  <last_update_submitted>December 16, 2020</last_update_submitted>
  <last_update_submitted_qc>December 16, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Ultrasonography</keyword>
  <keyword>Point-of-care ultrasound</keyword>
  <keyword>Resuscitation</keyword>
  <keyword>Critical Care</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypotension</mesh_term>
    <mesh_term>Shock</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No plan for now to share individual participant data (IPD), but sharing anonymized data could be considered in the future.</ipd_description>
  </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/NCT03296891
org study id: 109038
nct id: NCT03296891
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This project aims to determine the feasibility of conducting a randomized controlled trial
      investigating point of care ultrasound guided resuscitation compared with usual care in the
      management of shock at the Critical Care Trauma Centre (CCTC) in London Health Science Centre
      (LHSC).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Recruitment rate
time frame: averaged over 48 week period (active recruitment taking place in 48 of those 52 weeks)
description: Number of patients who were successfully enrolled in the study per given week.
measure: Mortality
time frame: 28 days
description: proportion of patients who are deceased for any reason at 28 days
measure: Successful randomization rate
time frame: 28 days
description: proportion of eligible patients who were randomized within the window for enrolment
measure: Protocol adherence rate
time frame: 28 days
description: Proportion of participants in the intervention arm that received the intended intervention
measure: Contamination rate
time frame: 28 days
description: Proportion of participants who were randomized to the control arm and inadvertently received the intervention
measure: Revoked deferred consent rate
time frame: 28 days
description: Proportion of participants whose consent was revoked
measure: ICU length of stay
time frame: 28 days
description: total days spent in ICU from time of admission to time of patient discharge
measure: Ventilator free days
time frame: 28 days
description: Days alive and free of mechanical ventilation at 28 days
measure: Continuous renal replacement therapy free days
time frame: 28 days
description: Days alive and free of vasoactive medications at 28 days
measure: Vasoactive medication free days
time frame: 28 days
description: Days alive and free of vasoactive medications at 28 days
measure: Cumulative fluid balance
time frame: 7 days
description: Fluid balance at 7 days post ICU admission or at time of discharge
measure: Acute Kidney Injury (AKIN) stage
time frame: 7 days
description: AKIN stage at 7 days post ICU admission or at time of discharge
arm group label: PoCUS Guided Resuscitation of Shock
arm group type: Active Comparator
description: Participants randomized to this arm of the study will undergo PoCUS guided resuscitation of shock.
arm group label: Usual Care
arm group type: No Intervention
description: Participants randomized to the 'usual care' arm of the study will be suggested to have the following guide resuscitation: 1) Pulse pressure variation (PPV), stroke volume variation (SVV) and/or systolic pressure variation (SPV) on their arterial line, 2) central venous pressure (CVP) and oxygen saturation(ScvO2) measurement, 3) Passive leg raise (PLR) maneuver, and/or 4) pulmonary artery catheter
intervention type: Other
intervention name: PoCUS Guided Resuscitation of Shock
description: Point-of-care ultrasound (PoCUS) will be used to guide resuscitation of the participant with shock. A PoCUS study will consist of limited echocardiography (LE) and thoracic ultrasound (TUS).
arm group label: PoCUS Guided Resuscitation of Shock
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Hypotension
mesh term: Shock
sharing ipd: No
ipd description: No plan for now to share individual participant data (IPD), but sharing anonymized data could be considered in the future.