<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/NCT02212509</url>
  </required_header>
  <id_info>
    <org_study_id>201203074RIC</org_study_id>
    <nct_id>NCT02212509</nct_id>
  </id_info>
  <brief_title>Functional Recovery After Cardiac Surgery : Does Delirium and Calorie Intake Matter?</brief_title>
  <official_title>Functional Recovery After Cardiac Surgery : Does Delirium and Calorie Intake Matter?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Taiwan University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aims of the cohort study is to describe the rates of 30-day surgical complication,&#xD;
      functional decline, frailty and one-year mortality for patients experienced cardiac surgery&#xD;
      and to delineate the trajectory of functional capacity 1 year after surgery for the patients.&#xD;
      It also will test whether the trajectory of functional varied significantly according to&#xD;
      delirium status and its type over the follow-up period and examine the patients' postsurgical&#xD;
      actual caloric/protein/fluid intake in relation to the functional capacity within 3 months&#xD;
      after surgery as well as evaluate whether activity levels, dietary diversity, and depressive&#xD;
      symptoms at 3,6, and 12 months affect patient outcome.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In Taiwan, 54.2% of cardiac surgical procedures in 2010 were performed on older patients (≧65&#xD;
      years) with higher rates of surgical complications, functional decline, and even death&#xD;
      reported. Despite the large number of older patients undergoing cardiac surgery with the goal&#xD;
      of improving functional capacity, the literature in this area is limited. Specifically, there&#xD;
      is little information about the functional outcomes 1 year after cardiac surgery for older&#xD;
      patients.&#xD;
&#xD;
      A prospective, longitudinal cohort study will be conducted to assess and follow patients aged&#xD;
      65 years and older who undergoing elective or non-elective cardiac surgery for one year after&#xD;
      surgery. All patients on the cardio-surgical wards of 5A, 5B, and 5CVI at National Taiwan&#xD;
      University Hospital will be screened for eligibility. Every patient ≧65 years admitted for&#xD;
      cardiac surgery will be approached and invited to participate. This cohort study aims to&#xD;
      1)describe the rates of 30-day surgical complication, functional decline, frailty, and&#xD;
      one-year mortality for older patients underwent cardiac surgery; 2) delineate the rajectory&#xD;
      of functional capacity 1 year after surgery for these patients; 3) test whether the&#xD;
      trajectory of functional capacity varied significantly according to delirium status and its&#xD;
      type over the one-year follow-up period; 4)examine patients' postsurgical actual&#xD;
      caloric/protein/fluid intake in relation to the functional capacity within 3 months after&#xD;
      surgery; and 5) evaluate hether activity levels, dietary diversity, and depressive symptoms&#xD;
      at 3, 6, and 12 months affect patient outcomes. Estimated 236 participants will be enrolled&#xD;
      to ensure the power of study.&#xD;
&#xD;
      Data will be analyzed using the SAS package. The Generalized Estimating Equation (GEE) will&#xD;
      be performed to identify the risk factors and to delineate the trajectory of functional&#xD;
      capacity 1 year after cardiac surgery for older patients. The findings will add to the&#xD;
      development of nursing intervention program to promote functional recovery for older patients&#xD;
      after cardiac surgery&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2013</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Anticipated">December 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>physical activity function</measure>
    <time_frame>admission and 1 year after surgery</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>mortality</measure>
    <time_frame>1 year after surgery</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>30 days surgical complication</measure>
    <time_frame>30 days after surgery</time_frame>
  </other_outcome>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Disorder; Heart, Functional, Postoperative, Cardiac Surgery</condition>
  <eligibility>
    <study_pop>
      <textblock>
        patients on the cardio-surgical wards&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients over 20 years old&#xD;
&#xD;
          -  admitted for elective or non-elective cardiac surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  incapable of verbal communication&#xD;
&#xD;
          -  sensory impairment&#xD;
&#xD;
          -  intubation or respiratory isolation&#xD;
&#xD;
          -  patients with critical condition or coma&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>National Taiwan University Hospital</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Cheryl Chia-Hui Chen, RN, PHD</last_name>
      <phone>8862-23123456</phone>
      <phone_ext>88438</phone_ext>
      <email>cherylchen@ntu.edu.tw</email>
    </contact>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 6, 2014</study_first_submitted>
  <study_first_submitted_qc>August 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 8, 2014</study_first_posted>
  <last_update_submitted>August 6, 2014</last_update_submitted>
  <last_update_submitted_qc>August 6, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 8, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT02212509
org study id: 201203074RIC
nct id: NCT02212509
lead sponsor: 
has dmc: No
The aims of the cohort study is to describe the rates of 30-day surgical complication,
      functional decline, frailty and one-year mortality for patients experienced cardiac surgery
      and to delineate the trajectory of functional capacity 1 year after surgery for the patients.
      It also will test whether the trajectory of functional varied significantly according to
      delirium status and its type over the follow-up period and examine the patients' postsurgical
      actual caloric/protein/fluid intake in relation to the functional capacity within 3 months
      after surgery as well as evaluate whether activity levels, dietary diversity, and depressive
      symptoms at 3,6, and 12 months affect patient outcome.
In Taiwan, 54.2% of cardiac surgical procedures in 2010 were performed on older patients (≧65
      years) with higher rates of surgical complications, functional decline, and even death
      reported. Despite the large number of older patients undergoing cardiac surgery with the goal
      of improving functional capacity, the literature in this area is limited. Specifically, there
      is little information about the functional outcomes 1 year after cardiac surgery for older
      patients.

      A prospective, longitudinal cohort study will be conducted to assess and follow patients aged
      65 years and older who undergoing elective or non-elective cardiac surgery for one year after
      surgery. All patients on the cardio-surgical wards of 5A, 5B, and 5CVI at National Taiwan
      University Hospital will be screened for eligibility. Every patient ≧65 years admitted for
      cardiac surgery will be approached and invited to participate. This cohort study aims to
      1)describe the rates of 30-day surgical complication, functional decline, frailty, and
      one-year mortality for older patients underwent cardiac surgery; 2) delineate the rajectory
      of functional capacity 1 year after surgery for these patients; 3) test whether the
      trajectory of functional capacity varied significantly according to delirium status and its
      type over the one-year follow-up period; 4)examine patients' postsurgical actual
      caloric/protein/fluid intake in relation to the functional capacity within 3 months after
      surgery; and 5) evaluate hether activity levels, dietary diversity, and depressive symptoms
      at 3, 6, and 12 months affect patient outcomes. Estimated 236 participants will be enrolled
      to ensure the power of study.

      Data will be analyzed using the SAS package. The Generalized Estimating Equation (GEE) will
      be performed to identify the risk factors and to delineate the trajectory of functional
      capacity 1 year after cardiac surgery for older patients. The findings will add to the
      development of nursing intervention program to promote functional recovery for older patients
      after cardiac surgery
observational model: Cohort
time perspective: Prospective
measure: physical activity function
time frame: admission and 1 year after surgery
measure: mortality
time frame: 1 year after surgery
measure: 30 days surgical complication
time frame: 30 days after surgery
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
facility: 
status: Recruiting
contact: 
country: Taiwan
responsible party type: Sponsor
mesh term: Delirium