xml: <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/NCT05985525</url>
    </required_header>
    <id_info>
      <org_study_id>HS25043</org_study_id>
      <nct_id>NCT05985525</nct_id>
    </id_info>
    <brief_title>Microvascular Monitoring in Circulatory Shock and Sepsis (MiMICSS)</brief_title>
    <acronym>MiMICSS</acronym>
    <official_title>Microvascular Monitoring in Circulatory Shock and Sepsis (MiMICSS): Prospective Observational Cohort Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Manitoba</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Manitoba</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>
        Investigation of the feasibility of using near-infrared spectroscopy (NIRS) to monitor&#xD;
        microvascular function in critically ill patients.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a prospective observational study using non-invasive NIRS for microvascular&#xD;
        monitoring in the ICU. The study involves no interventions above standard of care other than&#xD;
        the application of the NIRS monitors.&#xD;
  &#xD;
        NIRS will be applied to skeletal muscle and the brain longitudinally throughout ICU&#xD;
        admission. Vital signs are extracted continuously from the ICU monitor and clinical data are&#xD;
        recorded from patient records.&#xD;
  &#xD;
        The broad goals of the study are:&#xD;
  &#xD;
          1. Determine the feasibility of longitudinal NIRS monitoring in ICU patients&#xD;
  &#xD;
          2. Determine the ability to derive patient-specific microvascular metrics using NIRS&#xD;
  &#xD;
          3. Explore the relationship between microvascular metrics and ICU mortality&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">May 27, 2022</start_date>
    <completion_date type="Anticipated">May 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">May 31, 2025</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Recruitment</measure>
      <time_frame>30 days</time_frame>
      <description>Recruitment of two patients per month from each study site</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>protocol adherence</measure>
      <time_frame>14 days</time_frame>
      <description>collection of NIRS and clinical data for each monitoring session</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>NIRS and vital sign data quality</measure>
      <time_frame>14 days</time_frame>
      <description>NIRS and vital sign data is &gt;50% free of artifacts for &gt;80% of recording sessions to enable further analysis</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Optimal Map (MAPopt) derivation</measure>
      <time_frame>14 days</time_frame>
      <description>when MAP and NIRS data available together, ability to derive MAPopt from &gt;80% of recording sessions using correlation analysis</description>
    </secondary_outcome>
    <other_outcome>
      <measure>ICU mortality</measure>
      <time_frame>30 days</time_frame>
      <description>ICU mortality status</description>
    </other_outcome>
    <other_outcome>
      <measure>Hospital mortality</measure>
      <time_frame>100 days</time_frame>
      <description>Hospital mortality</description>
    </other_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Sepsis</condition>
    <condition>Shock</condition>
    <condition>Critical Illness</condition>
    <arm_group>
      <arm_group_label>Observational</arm_group_label>
      <description>All patients</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Skeletal muscle and cerebral NIRS (research device)</intervention_name>
      <description>NIRS applied on skeletal muscle and brain on days 1, 3, and 8 of ICU admission. Monitoring applied for up to 24hrs on each day.</description>
      <arm_group_label>Observational</arm_group_label>
      <other_name>PortaMon (Artinis Inc, Netherlands)</other_name>
      <other_name>PortaLite (Artinis Inc, Netherlands)</other_name>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Adults admitted to the ICU receiving invasive mechanical ventilation&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Admitted to ICU&#xD;
  &#xD;
            -  Receiving invasive mechanical ventilation&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Body Mass Index &gt;40&#xD;
  &#xD;
            -  More than 24 hours has elapsed since ICU admission&#xD;
  &#xD;
            -  Death is deemed to be imminent and inevitable during the next 24 hours&#xD;
  &#xD;
            -  Known allergy to the textile components of the device&#xD;
  &#xD;
            -  Significant clinical jaundice, ecchymosis&#xD;
  &#xD;
            -  COVID positive microbiological result&#xD;
  &#xD;
            -  The treating clinician believes that participation in the domain would not be in the&#xD;
               best interests of the patient&#xD;
  &#xD;
            -  Consent declined from patient or authorized third party&#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>Asher Mendelson, MD, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Manitoba</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Asher Mendelson, MD, PhD</last_name>
      <phone>2047871634</phone>
      <email>asher.mendelson@umanitoba.ca</email>
    </overall_contact>
    <location>
      <facility>
        <name>Health Sciences Centre Winnipeg</name>
        <address>
          <city>Winnipeg</city>
          <state>Manitoba</state>
          <zip>R3A 1R9</zip>
          <country>Canada</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Asher Mendelson, MD PhD</last_name>
        <phone>2047871634</phone>
        <email>asher.mendelson@umanitoba.ca</email>
      </contact>
      <investigator>
        <last_name>Frederick Zeiler, MD PhD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Ryan Zarychanski, MD MSc</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Canada</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 2, 2023</study_first_submitted>
    <study_first_submitted_qc>August 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 2, 2023</last_update_submitted>
    <last_update_submitted_qc>August 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Manitoba</investigator_affiliation>
      <investigator_full_name>Asher Mendelson</investigator_full_name>
      <investigator_title>Assistant Professor</investigator_title>
    </responsible_party>
    <keyword>Near-Infrared Spectroscopy</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Sepsis</mesh_term>
      <mesh_term>Toxemia</mesh_term>
      <mesh_term>Shock</mesh_term>
      <mesh_term>Critical Illness</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05985525
  org study id: HS25043
  nct id: NCT05985525
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Investigation of the feasibility of using near-infrared spectroscopy (NIRS) to monitor
        microvascular function in critically ill patients.
  This is a prospective observational study using non-invasive NIRS for microvascular
        monitoring in the ICU. The study involves no interventions above standard of care other than
        the application of the NIRS monitors.
  
        NIRS will be applied to skeletal muscle and the brain longitudinally throughout ICU
        admission. Vital signs are extracted continuously from the ICU monitor and clinical data are
        recorded from patient records.
  
        The broad goals of the study are:
  
          1. Determine the feasibility of longitudinal NIRS monitoring in ICU patients
  
          2. Determine the ability to derive patient-specific microvascular metrics using NIRS
  
          3. Explore the relationship between microvascular metrics and ICU mortality
  observational model: Cohort
  time perspective: Prospective
  measure: Recruitment
  time frame: 30 days
  description: Recruitment of two patients per month from each study site
  measure: protocol adherence
  time frame: 14 days
  description: collection of NIRS and clinical data for each monitoring session
  measure: NIRS and vital sign data quality
  time frame: 14 days
  description: NIRS and vital sign data is >50% free of artifacts for >80% of recording sessions to enable further analysis
  measure: Optimal Map (MAPopt) derivation
  time frame: 14 days
  description: when MAP and NIRS data available together, ability to derive MAPopt from >80% of recording sessions using correlation analysis
  measure: ICU mortality
  time frame: 30 days
  description: ICU mortality status
  measure: Hospital mortality
  time frame: 100 days
  description: Hospital mortality
  arm group label: Observational
  description: All patients
  intervention type: Device
  intervention name: Skeletal muscle and cerebral NIRS (research device)
  description: NIRS applied on skeletal muscle and brain on days 1, 3, and 8 of ICU admission. Monitoring applied for up to 24hrs on each day.
  arm group label: Observational
  other name: PortaMon (Artinis Inc, Netherlands)
  other name: PortaLite (Artinis Inc, Netherlands)
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Asher Mendelson, MD, PhD
  role: Principal Investigator
  affiliation: University of Manitoba
  last name: Asher Mendelson, MD, PhD
  phone: 2047871634
  email: asher.mendelson@umanitoba.ca
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  investigator: 
  country: Canada
  responsible party type: Principal Investigator
  investigator affiliation: University of Manitoba
  investigator full name: Asher Mendelson
  investigator title: Assistant Professor
  mesh term: Sepsis
  mesh term: Toxemia
  mesh term: Shock
  mesh term: Critical Illness
  sharing ipd: No