<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/NCT03015584</url>
  </required_header>
  <id_info>
    <org_study_id>1040524</org_study_id>
    <nct_id>NCT03015584</nct_id>
  </id_info>
  <brief_title>Systems Biology Approach to Cognitive Impairment After SepsiS</brief_title>
  <acronym>CASS</acronym>
  <official_title>Systems Biology Approach to Cognitive Impairment After SepsiS (CASS)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Intermountain Health Care, Inc.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Utah</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Intermountain Health Care, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will use systems biology techniques, especially RNA-seq, to understand cognitive&#xD;
      impairment after sepsis requiring an intensive care unit (ICU) admission.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2015</start_date>
  <completion_date type="Actual">July 2017</completion_date>
  <primary_completion_date type="Actual">July 2017</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>Hayling Sentence Completion test</measure>
    <time_frame>6 months</time_frame>
    <description>Measures executive function. 6-month Hayling Sentence Completion test is the prespecified primary outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Wechsler Memory Scale Logical Memory 1 assessment</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wechsler Memory Scale Logical Memory 1 assessment</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wechsler Memory Scale Logical Memory 2 assessment</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wechsler Memory Scale Logical Memory 2 assessment</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Digit Span memory assessment</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Digit Span memory assessment</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Verbal Fluency test</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Verbal Fluency test</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wechsler Similarities assessment</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wechsler Similarities assessment</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EuroQol five dimensions questionnaire (EQ-5D-3L)</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EuroQol five dimensions questionnaire (EQ-5D-3L)</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>36-item short form survey (SF-36)</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>36-item short form survey (SF-36)</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital Anxiety and Depression Scale (HADS)</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital Anxiety and Depression Scale (HADS)</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of Event Scale-Revised (IES-R)</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact of Event Scale-Revised (IES-R)</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional Performance Inventory (FPI)</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional Performance Inventory (FPI)</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional Assessment of Chronic Illness Therapy (FACIT)</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional Assessment of Chronic Illness Therapy (FACIT)</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Activities of Daily Living/Instrumental Activities of Daily Living (ADL/IADL)</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Activities of Daily Living/Instrumental Activities of Daily Living (ADL/IADL)</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hayling Sentence Completion test</measure>
    <time_frame>3 months</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>90-day mortality</measure>
    <time_frame>90 days</time_frame>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">40</enrollment>
  <condition>Sepsis</condition>
  <condition>Cognitive Impairment</condition>
  <arm_group>
    <arm_group_label>Septic patients admitted to the ICU</arm_group_label>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood for RNA-seq and whole exome sequencing&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with sepsis or septic shock, admitted to the ICU.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
        - Either SEPSIS or SEPTIC SHOCK&#xD;
&#xD;
        A. SEPSIS:&#xD;
&#xD;
        PRESENCE OF&#xD;
&#xD;
          1. Suspected or confirmed infection AND&#xD;
&#xD;
          2. Organ dysfunction as defined by a SOFA &gt;= 2 above baseline (if no baseline data&#xD;
             available, SOFA assumed to be 0)&#xD;
&#xD;
        OR&#xD;
&#xD;
        B. SEPTIC SHOCK:&#xD;
&#xD;
        AFTER INTRAVENOUS INFUSION OF 20ML/KG CRYSTALLOID OR EQUIVALENT, PRESENCE OF&#xD;
&#xD;
          1. Suspected or confirmed infection AND&#xD;
&#xD;
          2. Lactate &gt; 2 mmol/L AND&#xD;
&#xD;
          3. Receiving vasopressors&#xD;
&#xD;
        Enrollment within 48 hours of ICU admission.&#xD;
&#xD;
        Must live within 200 miles of Intermountain Medical Center&#xD;
&#xD;
        Subject is at least 18 years of age or older&#xD;
&#xD;
        Must speak English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Onset of sepsis or septic shock &gt;24 hours after hospital admission&#xD;
&#xD;
          -  Patients transferred from another hospital except for directly from an emergency room&#xD;
&#xD;
          -  Patients transferred to the ICU &gt;48 hours after admission to Intermountain Medical&#xD;
             Center (must have been admitted with diagnosis of sepsis)&#xD;
&#xD;
          -  Prior traumatic brain injury, stroke, or intracranial hemorrhage&#xD;
&#xD;
          -  DNR/DNI order before study enrollment&#xD;
&#xD;
          -  Primary diagnosis of stroke or intracranial hemorrhage&#xD;
&#xD;
          -  Known preexisting dementia or substantial cognitive impairment of any cause&#xD;
             (established from both chart review, report and/or score ≥3 on IQ Code screening.&#xD;
&#xD;
          -  Prior cardiac surgery (coronary artery bypass grafting or surgical valve replacement&#xD;
             or repair)&#xD;
&#xD;
          -  Known schizophrenia or other psychotic thought disorder&#xD;
&#xD;
          -  Known pregnancy&#xD;
&#xD;
          -  Primary diagnosis of drug overdose&#xD;
&#xD;
          -  Attending physician deems aggressive care unsuitable&#xD;
&#xD;
          -  Enrolled in another study if that study involves drug interventions&#xD;
&#xD;
          -  Not expected to survive 48 hours&#xD;
&#xD;
          -  Has a terminal condition independent of the acute illness that is expected to lead to&#xD;
             death within 6 months&#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>Samuel Brown, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Intermountain Health Care, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Intermountain Medical Center</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>December 8, 2016</study_first_submitted>
  <study_first_submitted_qc>January 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 10, 2017</study_first_posted>
  <last_update_submitted>July 17, 2018</last_update_submitted>
  <last_update_submitted_qc>July 17, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 18, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Intermountain Health Care, Inc.</investigator_affiliation>
    <investigator_full_name>Samuel Brown</investigator_full_name>
    <investigator_title>Director of Center for Humanizing Critical Care; Assistant Director of Critical Care Echocardiography Service, Intermountain Medical Center</investigator_title>
  </responsible_party>
  <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>Cognitive Dysfunction</mesh_term>
  </condition_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/NCT03015584
org study id: 1040524
nct id: NCT03015584
lead sponsor: 
collaborator: 
has dmc: No
This study will use systems biology techniques, especially RNA-seq, to understand cognitive
      impairment after sepsis requiring an intensive care unit (ICU) admission.
observational model: Cohort
time perspective: Prospective
measure: Hayling Sentence Completion test
time frame: 6 months
description: Measures executive function. 6-month Hayling Sentence Completion test is the prespecified primary outcome.
measure: Wechsler Memory Scale Logical Memory 1 assessment
time frame: 3 months
measure: Wechsler Memory Scale Logical Memory 1 assessment
time frame: 6 months
measure: Wechsler Memory Scale Logical Memory 2 assessment
time frame: 3 months
measure: Wechsler Memory Scale Logical Memory 2 assessment
time frame: 6 months
measure: Digit Span memory assessment
time frame: 3 months
measure: Digit Span memory assessment
time frame: 6 months
measure: Verbal Fluency test
time frame: 3 months
measure: Verbal Fluency test
time frame: 6 months
measure: Wechsler Similarities assessment
time frame: 3 months
measure: Wechsler Similarities assessment
time frame: 6 months
measure: EuroQol five dimensions questionnaire (EQ-5D-3L)
time frame: 3 months
measure: EuroQol five dimensions questionnaire (EQ-5D-3L)
time frame: 6 months
measure: 36-item short form survey (SF-36)
time frame: 3 months
measure: 36-item short form survey (SF-36)
time frame: 6 months
measure: Hospital Anxiety and Depression Scale (HADS)
time frame: 3 months
measure: Hospital Anxiety and Depression Scale (HADS)
time frame: 6 months
measure: Impact of Event Scale-Revised (IES-R)
time frame: 3 months
measure: Impact of Event Scale-Revised (IES-R)
time frame: 6 months
measure: Functional Performance Inventory (FPI)
time frame: 3 months
measure: Functional Performance Inventory (FPI)
time frame: 6 months
measure: Functional Assessment of Chronic Illness Therapy (FACIT)
time frame: 3 months
measure: Functional Assessment of Chronic Illness Therapy (FACIT)
time frame: 6 months
measure: Activities of Daily Living/Instrumental Activities of Daily Living (ADL/IADL)
time frame: 3 months
measure: Activities of Daily Living/Instrumental Activities of Daily Living (ADL/IADL)
time frame: 6 months
measure: Hayling Sentence Completion test
time frame: 3 months
measure: 90-day mortality
time frame: 90 days
arm group label: Septic patients admitted to the ICU
Blood for RNA-seq and whole exome sequencing
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Samuel Brown, MD
role: Principal Investigator
affiliation: Intermountain Health Care, Inc.
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Intermountain Health Care, Inc.
investigator full name: Samuel Brown
investigator title: Director of Center for Humanizing Critical Care; Assistant Director of Critical Care Echocardiography Service, Intermountain Medical Center
mesh term: Sepsis
mesh term: Toxemia
mesh term: Cognitive Dysfunction
sharing ipd: No