<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/NCT03246165</url>
  </required_header>
  <id_info>
    <org_study_id>825/11</org_study_id>
    <nct_id>NCT03246165</nct_id>
  </id_info>
  <brief_title>Predictive Factors and Complications of Delirium</brief_title>
  <official_title>Incidence, Predictive Factors and Complications of Delirium in Postoperative Cardiac Surgery Elderly Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Sao Paulo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hospital de Messejana</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Sao Paulo</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>
      The objective of this research was to determine the incidence, predisposing and triggering&#xD;
      factors of delirium following cardiac surgery and its consequences within 30 days of surgery&#xD;
      and during a 12-18-month follow-up in older adult patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Delirium is a transient and fluctuating course syndrome of acute onset that is characterized&#xD;
      by reduced level of consciousness, global cognitive dysfunction, and disorder in the&#xD;
      sleep-wake cycle. In patients undergoing cardiac surgery, delirium is a complication that&#xD;
      affects 2-57% of the patients, reaching as high as 73% in older subjects.&#xD;
&#xD;
      The identification of patients at high risk for delirium is important to deliver proper care&#xD;
      and avoid the consequences of this complication. However, previous studies published on the&#xD;
      subject have not delivered definitive results in the cardiac surgery setting. Low educational&#xD;
      level has also been studied as a risk factor for delirium after surgery but never in a group&#xD;
      of cardiac surgery patients that includes a significant rate of illiteracy.&#xD;
&#xD;
      The objective of this research was to determine the incidence, predisposing and triggering&#xD;
      factors of delirium following cardiac surgery and its consequences within 30 days of surgery&#xD;
      and during a 12-18-month follow-up in older adult patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2011</start_date>
  <completion_date type="Actual">June 30, 2015</completion_date>
  <primary_completion_date type="Actual">December 30, 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Delirium</measure>
    <time_frame>Until hospital discharge or 30 days after surgery, and for up to 18 months.</time_frame>
    <description>Delirium was assessed using the Confusion Assessment Method for the Intensive Care Unit</description>
  </primary_outcome>
  <enrollment type="Actual">173</enrollment>
  <condition>Delirium</condition>
  <condition>Surgery--Complications</condition>
  <condition>Age Problem</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Cardiac surgery</intervention_name>
    <description>Coronary bypass, heart valve replacement</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients submitted to perioperative evaluation for elective cardiac surgery at the hospital&#xD;
        de Messejana in Fortaleza, Ceara.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Elective cardiovascular surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Blindness,&#xD;
&#xD;
          -  deafness,&#xD;
&#xD;
          -  previous stroke&#xD;
&#xD;
          -  dementia&#xD;
&#xD;
          -  delirium at inclusion, preoperatively&#xD;
&#xD;
          -  creatinine clearance &lt; 30 ml/min&#xD;
&#xD;
          -  emergency surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>August 7, 2017</study_first_submitted>
  <study_first_submitted_qc>August 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 11, 2017</study_first_posted>
  <last_update_submitted>March 23, 2019</last_update_submitted>
  <last_update_submitted_qc>March 23, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 26, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Sao Paulo</investigator_affiliation>
    <investigator_full_name>Bruno Caramelli</investigator_full_name>
    <investigator_title>Associate Professor of Cardiology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Delirium</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/NCT03246165
org study id: 825/11
nct id: NCT03246165
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The objective of this research was to determine the incidence, predisposing and triggering
      factors of delirium following cardiac surgery and its consequences within 30 days of surgery
      and during a 12-18-month follow-up in older adult patients.
Delirium is a transient and fluctuating course syndrome of acute onset that is characterized
      by reduced level of consciousness, global cognitive dysfunction, and disorder in the
      sleep-wake cycle. In patients undergoing cardiac surgery, delirium is a complication that
      affects 2-57% of the patients, reaching as high as 73% in older subjects.

      The identification of patients at high risk for delirium is important to deliver proper care
      and avoid the consequences of this complication. However, previous studies published on the
      subject have not delivered definitive results in the cardiac surgery setting. Low educational
      level has also been studied as a risk factor for delirium after surgery but never in a group
      of cardiac surgery patients that includes a significant rate of illiteracy.

      The objective of this research was to determine the incidence, predisposing and triggering
      factors of delirium following cardiac surgery and its consequences within 30 days of surgery
      and during a 12-18-month follow-up in older adult patients.
observational model: Case-Control
time perspective: Prospective
measure: Delirium
time frame: Until hospital discharge or 30 days after surgery, and for up to 18 months.
description: Delirium was assessed using the Confusion Assessment Method for the Intensive Care Unit
intervention type: Procedure
intervention name: Cardiac surgery
description: Coronary bypass, heart valve replacement
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: University of Sao Paulo
investigator full name: Bruno Caramelli
investigator title: Associate Professor of Cardiology
mesh term: Delirium
sharing ipd: No