<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/NCT03831529</url>
  </required_header>
  <id_info>
    <org_study_id>PSS2017/ANGIOCHOLREA-NOVY/NK</org_study_id>
    <nct_id>NCT03831529</nct_id>
  </id_info>
  <brief_title>Outcomes of Elderly Patients Admitted to the Intensive Care Unit With Severe Acute Cholangitis</brief_title>
  <acronym>ANGIOCHOLREA</acronym>
  <official_title>Prognostic Factors Associated With Mortality Within 6 Months Among Critically Ill Elderly Patients Admitted to the Intensive Care Unit With Severe Acute Cholangitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Central Hospital, Nancy, France</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Central Hospital, Nancy, France</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 aging of the population goes along with an increased demand for intensive care among very&#xD;
      elderly patients (above 75-80 years old). At the same time, there is a decline in the supply&#xD;
      of intensive care units (ICU). The 1-year mortality of patients above 80 years old in ICU&#xD;
      ranged from 40 to 70%. Moreover, many survivors suffer from long-term sequelae as poor&#xD;
      quality of life, cognitive impairment and functional disability.&#xD;
&#xD;
      It is unclear under what conditions older patients may benefit from ICU admission.&#xD;
      Cholangitis frequently occured in older patient. Moreover, severe acute cholangitis is a&#xD;
      potentially life threatening disease characterized by a biliary obstruction and an infection&#xD;
      of the bile possibly evolving towards systemic infection, shock and death. Because of its&#xD;
      potential rapid reversibility of symptom thanks to early intravenous antibiotics and biliary&#xD;
      decompression with drainage, old patients suffering from acute cholangitis are easily&#xD;
      admitted to intensive care unit.&#xD;
&#xD;
      To date, there is a lack of data about the outcome in this population admitted to the&#xD;
      intensive care unit with acute cholangitis.&#xD;
&#xD;
      The aim of the current study is to describe the outcomes in elderly patients (&gt; 75 years old)&#xD;
      admitted to the ICU with acute cholangitis and to identify prognostics factors associated&#xD;
      with long term mortality (6 months).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 18, 2018</start_date>
  <completion_date type="Actual">January 15, 2019</completion_date>
  <primary_completion_date type="Actual">November 14, 2018</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>mortality</measure>
    <time_frame>180 days</time_frame>
    <description>rate of survivors and non survivors</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>mortality</measure>
    <time_frame>90 days</time_frame>
    <description>rate of survivors and non survivors</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>mortality</measure>
    <time_frame>28 days</time_frame>
    <description>rate of survivors and non survivors</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>factors associated with 6 months mortality (underlying condition)</measure>
    <time_frame>Day 1</time_frame>
    <description>Functional status : presence or absence of denutrition defined by a BMI &lt; 19 kg/m2 and/or albuminemia &lt; 30 g/l and/or loss of weight &gt; 5% during the last month (or &gt; 10% during the last three months)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>factors associated with 6 months mortality (severity score)</measure>
    <time_frame>Day 1</time_frame>
    <description>Simplified Acute Physiology Score 2 Minimum value : 0 / Maximun value 163</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>factors associated with 6 months mortality (Presence of hemodynamic failure)</measure>
    <time_frame>Up to 7 days</time_frame>
    <description>infusion of catecholamine (ie norepinephrine) during the ICU stay, yes or not</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>factors associated with 6 months mortality (Presence of respiratory failure)</measure>
    <time_frame>Up to 7 days</time_frame>
    <description>number of day(s) under mechanical ventilation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>factors associated with 6 months mortality (Presence of renal failure)</measure>
    <time_frame>Up to 7 days</time_frame>
    <description>number od day(s) under renal replacement therapy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical evolution</measure>
    <time_frame>Day 3</time_frame>
    <description>Change in Sequential Organ Failure score between Day 1 and Day 3. We measured the Sepsis-related Organ Failure Assessment (SOFA) score at day and day 3 and then made the difference between the two scores the SOFA score could range between 0 and 24 We calculated the score at day 1 and day 3 and made the difference An absence or a small difference between the 2 days is associated with a worse outcome</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">204</enrollment>
  <condition>Cholangitis Infective</condition>
  <condition>Elderly Person</condition>
  <arm_group>
    <arm_group_label>ICU older patient</arm_group_label>
    <description>Older patient (&gt; 65 years old) admitted to ICU with severe acute cholangitis</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients &gt; 65 years old admitted to the ICU for acute severe cholangitis&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  &gt; 65 years old&#xD;
&#xD;
          -  ICU admission for acute cholangitis&#xD;
&#xD;
          -  follow up in the same center after the ICU stay&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  none&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>CHR Mercy</name>
      <address>
        <city>Metz</city>
        <state>Lorraine</state>
        <zip>57000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emmanuel NOVY</name>
      <address>
        <city>Vandoeuvre Les Nancy</city>
        <state>Lorraine</state>
        <zip>54500</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>January 18, 2019</study_first_submitted>
  <study_first_submitted_qc>February 4, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 6, 2019</study_first_posted>
  <last_update_submitted>February 4, 2019</last_update_submitted>
  <last_update_submitted_qc>February 4, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 6, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>critically ill</keyword>
  <keyword>mortality</keyword>
  <keyword>outcome</keyword>
  <keyword>treatment intensity level</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cholangitis</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/NCT03831529
org study id: PSS2017/ANGIOCHOLREA-NOVY/NK
nct id: NCT03831529
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aging of the population goes along with an increased demand for intensive care among very
      elderly patients (above 75-80 years old). At the same time, there is a decline in the supply
      of intensive care units (ICU). The 1-year mortality of patients above 80 years old in ICU
      ranged from 40 to 70%. Moreover, many survivors suffer from long-term sequelae as poor
      quality of life, cognitive impairment and functional disability.

      It is unclear under what conditions older patients may benefit from ICU admission.
      Cholangitis frequently occured in older patient. Moreover, severe acute cholangitis is a
      potentially life threatening disease characterized by a biliary obstruction and an infection
      of the bile possibly evolving towards systemic infection, shock and death. Because of its
      potential rapid reversibility of symptom thanks to early intravenous antibiotics and biliary
      decompression with drainage, old patients suffering from acute cholangitis are easily
      admitted to intensive care unit.

      To date, there is a lack of data about the outcome in this population admitted to the
      intensive care unit with acute cholangitis.

      The aim of the current study is to describe the outcomes in elderly patients (> 75 years old)
      admitted to the ICU with acute cholangitis and to identify prognostics factors associated
      with long term mortality (6 months).
observational model: Cohort
time perspective: Retrospective
measure: mortality
time frame: 180 days
description: rate of survivors and non survivors
measure: mortality
time frame: 90 days
description: rate of survivors and non survivors
measure: mortality
time frame: 28 days
description: rate of survivors and non survivors
measure: factors associated with 6 months mortality (underlying condition)
time frame: Day 1
description: Functional status : presence or absence of denutrition defined by a BMI < 19 kg/m2 and/or albuminemia < 30 g/l and/or loss of weight > 5% during the last month (or > 10% during the last three months)
measure: factors associated with 6 months mortality (severity score)
time frame: Day 1
description: Simplified Acute Physiology Score 2 Minimum value : 0 / Maximun value 163
measure: factors associated with 6 months mortality (Presence of hemodynamic failure)
time frame: Up to 7 days
description: infusion of catecholamine (ie norepinephrine) during the ICU stay, yes or not
measure: factors associated with 6 months mortality (Presence of respiratory failure)
time frame: Up to 7 days
description: number of day(s) under mechanical ventilation
measure: factors associated with 6 months mortality (Presence of renal failure)
time frame: Up to 7 days
description: number od day(s) under renal replacement therapy
measure: Clinical evolution
time frame: Day 3
description: Change in Sequential Organ Failure score between Day 1 and Day 3. We measured the Sepsis-related Organ Failure Assessment (SOFA) score at day and day 3 and then made the difference between the two scores the SOFA score could range between 0 and 24 We calculated the score at day 1 and day 3 and made the difference An absence or a small difference between the 2 days is associated with a worse outcome
arm group label: ICU older patient
description: Older patient (> 65 years old) admitted to ICU with severe acute cholangitis
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 65 Years
maximum age: N/A
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Cholangitis
sharing ipd: No