<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/NCT01679171</url>
  </required_header>
  <id_info>
    <org_study_id>PHRC-2012-01</org_study_id>
    <secondary_id>B120579-30</secondary_id>
    <nct_id>NCT01679171</nct_id>
  </id_info>
  <brief_title>One Year Outcome of Elderly Patients Admitted to an ICU and Mechanically Ventilated</brief_title>
  <acronym>SENIOREA</acronym>
  <official_title>One Year Outcome of Elderly Patients Admitted to an ICU and Mechanically Ventilated</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Angers</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Angers</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Elderly patients are increasingly admitted in the Intensive Care Unit. Short-term outcome&#xD;
      (e.g. hospital survival) of an ICU stay is improving in this population but little data have&#xD;
      been published on long-term outcome. Beyond survival, outcome assessment in the elderly&#xD;
      requires to evaluate several aspects of health: mental status, activity of daily living,&#xD;
      pain, depression, frailty… referred by geriatrician as &quot;comprehensive geriatric assessment'&#xD;
      (CGA).&#xD;
&#xD;
      The purpose of the SENIOREA study is to evaluate one year outcome of elderly patients&#xD;
      mechanically ventilated in the ICU by performing CGA one year after ICU admission. CGA will&#xD;
      be performed on the patients' site of living.&#xD;
&#xD;
      This prospective multicentric trial will be conducted over 8 medico-surgical ICUs.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 19, 2012</start_date>
  <completion_date type="Actual">July 10, 2015</completion_date>
  <primary_completion_date type="Actual">July 10, 2015</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>One year outcome</measure>
    <time_frame>1 year</time_frame>
    <description>Survival and health status will be assessed using comprehensive geriatric assessment (CGA)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Predictors of one-year outcome</measure>
    <time_frame>one year</time_frame>
    <description>The secondary assessment criteria as predictors of one year outcome will be researched among:&#xD;
CGA on ICU entry (based on family interview)&#xD;
Vitamin D blood concentration on ICU entry&#xD;
SOFA and SAPSII score on ICU entry&#xD;
Duration of organ dysfunction (ventilator support, renal replacement therapy, vasopressor)&#xD;
ICU length of stay</description>
  </secondary_outcome>
  <enrollment type="Actual">489</enrollment>
  <condition>Elderly Care</condition>
  <eligibility>
    <study_pop>
      <textblock>
        All patients aged 75 and over admitted in one of the participating ICU and requiring&#xD;
        mechanical ventilation will be recruited for this study&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients aged 75 or over&#xD;
&#xD;
          2. Admitted in a participating ICU&#xD;
&#xD;
          3. Requiring mechanical ventilation (invasive or non invasive), initiated before ICU&#xD;
             admission or during the 48 first hours after admission.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Non French-speaking person&#xD;
&#xD;
          2. Failure to obtain a consent by persons authorized to do so.&#xD;
&#xD;
          3. Person non-beneficiary of a social security system.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>75 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nicolas Lerolle</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU Angers France</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Intensive care unit - CHU Angers</name>
      <address>
        <city>Angers</city>
        <zip>49933</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>August 28, 2012</study_first_submitted>
  <study_first_submitted_qc>August 30, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 5, 2012</study_first_posted>
  <last_update_submitted>May 11, 2017</last_update_submitted>
  <last_update_submitted_qc>May 11, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 12, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Elderly</keyword>
  <keyword>Intensive care unit</keyword>
  <keyword>Outcome</keyword>
  <keyword>Comprehensive geriatric assessment</keyword>
  <!-- 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/NCT01679171
org study id: PHRC-2012-01
secondary id: B120579-30
nct id: NCT01679171
lead sponsor: 
has dmc: Yes
Elderly patients are increasingly admitted in the Intensive Care Unit. Short-term outcome
      (e.g. hospital survival) of an ICU stay is improving in this population but little data have
      been published on long-term outcome. Beyond survival, outcome assessment in the elderly
      requires to evaluate several aspects of health: mental status, activity of daily living,
      pain, depression, frailty… referred by geriatrician as "comprehensive geriatric assessment'
      (CGA).

      The purpose of the SENIOREA study is to evaluate one year outcome of elderly patients
      mechanically ventilated in the ICU by performing CGA one year after ICU admission. CGA will
      be performed on the patients' site of living.

      This prospective multicentric trial will be conducted over 8 medico-surgical ICUs.
observational model: Cohort
time perspective: Prospective
measure: One year outcome
time frame: 1 year
description: Survival and health status will be assessed using comprehensive geriatric assessment (CGA)
measure: Predictors of one-year outcome
time frame: one year
description: The secondary assessment criteria as predictors of one year outcome will be researched among:
CGA on ICU entry (based on family interview)
Vitamin D blood concentration on ICU entry
SOFA and SAPSII score on ICU entry
Duration of organ dysfunction (ventilator support, renal replacement therapy, vasopressor)
ICU length of stay
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 75 Years
maximum age: N/A
healthy volunteers: No
last name: Nicolas Lerolle
role: Principal Investigator
affiliation: CHU Angers France
facility: 
country: France
responsible party type: Sponsor