<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/NCT02206880</url>
  </required_header>
  <id_info>
    <org_study_id>DELIRIUM CS-Canada</org_study_id>
    <nct_id>NCT02206880</nct_id>
  </id_info>
  <brief_title>The Delirium-CS Canada Study</brief_title>
  <acronym>DELIRIUM-CS</acronym>
  <official_title>Examining DELIRIUM in Postoperative Cardiac Surgery Patient in Canada: Providing a National &quot;Snapshot&quot; of an Increasingly Devastating Complication</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St. Boniface Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Foothills Medical Centre</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Mazankowski Alberta Heart Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>London Health Sciences Centre</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Southlake Regional Health Centre</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Toronto General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hamilton Health Sciences Corporation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ottawa Heart Institute Research Corporation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Royal Victoria Hospital, Canada</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Montreal Heart Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>New Brunswick Heart Centre</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Queen Elizabeth II Health Sciences Centre</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>St. Boniface Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Delirium is a prevalent complication following cardiac surgery that is under-recognized using&#xD;
      current methods of delirium detection and that may be better identified through a systematic&#xD;
      and standardized perioperative screening protocol.&#xD;
&#xD;
      The purpose of this study is to determine the incidence of postoperative delirium in the&#xD;
      current era of cardiac surgery using a validated delirium-screening tool.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Delirium is an acute confusional state characterized by fluctuating mental status,&#xD;
      inattention, and either disorganized thinking or altered level of consciousness. It has long&#xD;
      been recognized as a complication of cardiac surgery, a condition more likely to be&#xD;
      experienced among elderly patients and those with greater comorbid disease burden. In recent&#xD;
      years, increasing attention has been paid to the negative effect of delirium on&#xD;
      post-operative outcomes, including long-term survival, freedom from hospital readmission and&#xD;
      reduced cognitive and functional recovery. Despite this, little is still known about the true&#xD;
      incidence of delirium following cardiac surgery, with published rates of delirium&#xD;
      post-cardiac surgery ranging widely from 3% - 78%.&#xD;
&#xD;
      From September 1, 2014 to November 30, 2014, ALL patients undergoing cardiac surgery at each&#xD;
      of the participating centers will be screened for post-operative delirium. Patients will NOT&#xD;
      be excluded on the basis of urgency or procedure type. Delirium screening will be conducted&#xD;
      for either up to 7 days following their date of surgery or up until their date of initial&#xD;
      discharge from the intensive care unit, whichever comes first. Each center will be allowed to&#xD;
      employ the delirium-screening tool currently in use at their institution provided that the&#xD;
      tool is either the Intensive Care Delirium Screening Checklist (ICDSC) or Confusion&#xD;
      Assessment Method for the Intensive Care Unit (CAM-ICU). It is intended that either ICDSC or&#xD;
      CAM-ICU, paired with a Richmond Agitation and Sedation Scale (RASS) or the Riker Sedation and&#xD;
      Agitation Scale (SAS) be administered once per shift (i.e. with first assessment in the&#xD;
      morning and a second assessment with the beginning of the evening shift). In addition, data&#xD;
      regarding baseline demographic and clinical characteristics will be collected as well as data&#xD;
      regarding the procedure performed (see Case Report Form (CRF). Patients will be considered as&#xD;
      having had post-operative delirium if the results of at least one of the screening tests&#xD;
      administered yielded a positive finding of delirium. In addition to reporting an overall rate&#xD;
      of delirium, unadjusted and adjusted incidence rates of delirium will be reported by&#xD;
      institution and for the entire cohort. Risk-adjustment will be performed using multivariate&#xD;
      regression modeling techniques.&#xD;
&#xD;
      This study will be the first to report on incidence rates of delirium following cardiac&#xD;
      surgery across multiple centers employing standardized screening methodologies. The results&#xD;
      of this study will provide valuable insight into the true burden of delirium among patients&#xD;
      having undergone a cardiac surgical procedure in the current era. This is the first step in&#xD;
      creating a multifaceted delirium prevention/treatment clinical pathway for the cardiac&#xD;
      surgery patient.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2014</start_date>
  <completion_date type="Actual">July 2018</completion_date>
  <primary_completion_date type="Actual">January 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of Delirium following Cardiac Surgery</measure>
    <time_frame>Delirium screening will be conducted for either up to 7 days following their date of surgery or up until their date of initial discharge from the intensive care unit, whichever comes first.</time_frame>
    <description>Each center will be allowed to employ the delirium-screening tool currently in use at their institution provided that the tool is either the Intensive Care Delirium Screening Checklist (ICDSC) or Confusion Assessment Method for the Intensive Care Unit (CAM-ICU). It is intended that either ICDSC or CAM-ICU, paired with a Richmond Agitation and Sedation Scale (RASS) or the Riker Sedation and Agitation Scale (SAS) be administered once per shift (i.e. with first assessment in the morning and a second assessment with the beginning of the evening shift). In addition, data regarding baseline demographic and clinical characteristics will be collected as well as data regarding the procedure performed (see Case Report Form (CRF). Patients will be considered as having had post-operative delirium if the results of at least one of the screening tests administered yielded a positive finding of delirium.</description>
  </primary_outcome>
  <enrollment type="Actual">235</enrollment>
  <condition>Delirium</condition>
  <eligibility>
    <study_pop>
      <textblock>
        All patients undergoing cardiac surgery who are admitted to an ICU or CSRU following their&#xD;
        procedure at twelve Canadian tertiary cardiac surgery centers in which patients are managed&#xD;
        post-operatively in an intensive care unit (ICU) or cardiac surgery recovery unit (CSRU)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients undergoing cardiac surgery who are admitted to an ICU or CSRU following&#xD;
             their procedure&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients in whom delirium cannot be reliably identified (e.g., previous debilitating&#xD;
             stroke, cerebral palsy, severe dementia, severe hearing disabilities or inability to&#xD;
             understand English or French, active seizure disorder or Child-Pugh class B or C&#xD;
             cirrhosis)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rakesh C. Arora, MD, PhD, FRCSC</last_name>
    <role>Principal Investigator</role>
    <affiliation>St. Boniface General Hospital - Cardiac Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Foothills Medical Centre</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>T2N 2T9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mazankowski Alberta Heart Institute</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T6G 2B7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Boniface General Hospital</name>
      <address>
        <city>Winnipeg</city>
        <state>Manitoba</state>
        <zip>R3C 4J8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New Brunswick Heart Centre</name>
      <address>
        <city>Saint John</city>
        <state>New Brunswick</state>
        <zip>E2L 4L4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>QEII Health Sciences Centre</name>
      <address>
        <city>Halifax</city>
        <state>Nova Scotia</state>
        <zip>B3H 2Y9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hamilton General Hospital</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8L2X2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>London Health Sciences Centre</name>
      <address>
        <city>London</city>
        <state>Ontario</state>
        <zip>N6A 5A5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southlake Regional Health Centre</name>
      <address>
        <city>Newmarket</city>
        <state>Ontario</state>
        <zip>L3Y 2P9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Ottawa Heart Institute</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1Y 4W7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Toronto General Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 2C4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Montreal Heart Institute</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H1T 1C8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Victoria Hospital</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H3A 1A1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>July 30, 2014</study_first_submitted>
  <study_first_submitted_qc>July 31, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 1, 2014</study_first_posted>
  <last_update_submitted>August 15, 2018</last_update_submitted>
  <last_update_submitted_qc>August 15, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 16, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>St. Boniface Hospital</investigator_affiliation>
    <investigator_full_name>Dr. Rakesh C. Arora</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Thoracic Surgery</keyword>
  <keyword>Delirium</keyword>
  <keyword>Cardiopulmonary Bypass</keyword>
  <keyword>Intensive Care</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Delirium</mesh_term>
  </condition_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/NCT02206880
org study id: DELIRIUM CS-Canada
nct id: NCT02206880
lead sponsor: 
collaborator: 
collaborator: 
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collaborator: 
has dmc: No
Delirium is a prevalent complication following cardiac surgery that is under-recognized using
      current methods of delirium detection and that may be better identified through a systematic
      and standardized perioperative screening protocol.

      The purpose of this study is to determine the incidence of postoperative delirium in the
      current era of cardiac surgery using a validated delirium-screening tool.
Delirium is an acute confusional state characterized by fluctuating mental status,
      inattention, and either disorganized thinking or altered level of consciousness. It has long
      been recognized as a complication of cardiac surgery, a condition more likely to be
      experienced among elderly patients and those with greater comorbid disease burden. In recent
      years, increasing attention has been paid to the negative effect of delirium on
      post-operative outcomes, including long-term survival, freedom from hospital readmission and
      reduced cognitive and functional recovery. Despite this, little is still known about the true
      incidence of delirium following cardiac surgery, with published rates of delirium
      post-cardiac surgery ranging widely from 3% - 78%.

      From September 1, 2014 to November 30, 2014, ALL patients undergoing cardiac surgery at each
      of the participating centers will be screened for post-operative delirium. Patients will NOT
      be excluded on the basis of urgency or procedure type. Delirium screening will be conducted
      for either up to 7 days following their date of surgery or up until their date of initial
      discharge from the intensive care unit, whichever comes first. Each center will be allowed to
      employ the delirium-screening tool currently in use at their institution provided that the
      tool is either the Intensive Care Delirium Screening Checklist (ICDSC) or Confusion
      Assessment Method for the Intensive Care Unit (CAM-ICU). It is intended that either ICDSC or
      CAM-ICU, paired with a Richmond Agitation and Sedation Scale (RASS) or the Riker Sedation and
      Agitation Scale (SAS) be administered once per shift (i.e. with first assessment in the
      morning and a second assessment with the beginning of the evening shift). In addition, data
      regarding baseline demographic and clinical characteristics will be collected as well as data
      regarding the procedure performed (see Case Report Form (CRF). Patients will be considered as
      having had post-operative delirium if the results of at least one of the screening tests
      administered yielded a positive finding of delirium. In addition to reporting an overall rate
      of delirium, unadjusted and adjusted incidence rates of delirium will be reported by
      institution and for the entire cohort. Risk-adjustment will be performed using multivariate
      regression modeling techniques.

      This study will be the first to report on incidence rates of delirium following cardiac
      surgery across multiple centers employing standardized screening methodologies. The results
      of this study will provide valuable insight into the true burden of delirium among patients
      having undergone a cardiac surgical procedure in the current era. This is the first step in
      creating a multifaceted delirium prevention/treatment clinical pathway for the cardiac
      surgery patient.
observational model: Other
time perspective: Prospective
measure: Incidence of Delirium following Cardiac Surgery
time frame: Delirium screening will be conducted for either up to 7 days following their date of surgery or up until their date of initial discharge from the intensive care unit, whichever comes first.
description: Each center will be allowed to employ the delirium-screening tool currently in use at their institution provided that the tool is either the Intensive Care Delirium Screening Checklist (ICDSC) or Confusion Assessment Method for the Intensive Care Unit (CAM-ICU). It is intended that either ICDSC or CAM-ICU, paired with a Richmond Agitation and Sedation Scale (RASS) or the Riker Sedation and Agitation Scale (SAS) be administered once per shift (i.e. with first assessment in the morning and a second assessment with the beginning of the evening shift). In addition, data regarding baseline demographic and clinical characteristics will be collected as well as data regarding the procedure performed (see Case Report Form (CRF). Patients will be considered as having had post-operative delirium if the results of at least one of the screening tests administered yielded a positive finding of delirium.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Rakesh C. Arora, MD, PhD, FRCSC
role: Principal Investigator
affiliation: St. Boniface General Hospital - Cardiac Sciences
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
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country: Canada
responsible party type: Principal Investigator
investigator affiliation: St. Boniface Hospital
investigator full name: Dr. Rakesh C. Arora
investigator title: Principal Investigator
mesh term: Delirium