<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/NCT03276650</url>
  </required_header>
  <id_info>
    <org_study_id>PSS2017/Still-ICU-LEMARIE/VS</org_study_id>
    <nct_id>NCT03276650</nct_id>
  </id_info>
  <brief_title>Admission of Adult-onset Still Disease Patients in the ICU</brief_title>
  <acronym>Still-ICU</acronym>
  <official_title>Admission of Adult-onset Still Disease Patients in the ICU: a French Retrospective Multicentric Study</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>
      Since its first description in 1971, diagnosing adult-onset Still's disease (AOSD), a rare&#xD;
      multisystemic disorder considered as a multigenic autoinflammatory syndrome, remains&#xD;
      challenging. Rarely, AOSD may present severe systemic manifestations and require intensive&#xD;
      care. The main purpose of the Stil ICU study is to make the first description of the&#xD;
      epidemiology of critically ill AOSD patients. The investigators will use a retrospective&#xD;
      cohort study design with dual recruitment strategies: (1) via the AOSD referral centres&#xD;
      network and (2) via a French academic medical ICU network.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Actual">August 1, 2018</completion_date>
  <primary_completion_date type="Actual">June 1, 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>number of patients</measure>
    <time_frame>At inclusion</time_frame>
    <description>Number of patients fulfilling the inclusion criteria</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>APACHE II</measure>
    <time_frame>24hour after ICU admission</time_frame>
    <description>Acute Physiologic Assessment and Chronic Health Evaluation II</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>through study completion, maximum 17,5 years after admission</time_frame>
    <description>Kaplan Meier</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of rehospitalisation in ICU</measure>
    <time_frame>through study completion, maximum 17,5 years after admission</time_frame>
    <description>need for critical care after the first hospitalisation in ICU</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>number of hospitalisation in internal medicine ward</measure>
    <time_frame>through study completion, maximum 17,5 years after admission</time_frame>
    <description>number of hospitalisation in internal medicine ward after the first ICU stay</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>recurrent relapses</measure>
    <time_frame>through study completion, maximum 17,5 years after admission</time_frame>
    <description>number of recurrent flares after the first hospitalisation in ICU</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">45</enrollment>
  <condition>Adult-Onset Still Disease</condition>
  <condition>Critically Ill</condition>
  <arm_group>
    <arm_group_label>critically ill AOSD patients</arm_group_label>
    <description>no intervention Data collection from hospitalisation reports (administrative, biological, clinical, outcome)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>data collection</intervention_name>
    <description>biological, administrative, clinical, outcome date</description>
    <arm_group_label>critically ill AOSD patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adult AOSD patients admitted to ICU&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  AOSD (history of newly diagnosed)&#xD;
&#xD;
          -  ICU admission between January 2001 and June 2017&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  adults under protection&#xD;
&#xD;
          -  admission in step-down unit&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>CHRU</name>
      <address>
        <city>Nancy</city>
        <zip>54000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>August 25, 2017</study_first_submitted>
  <study_first_submitted_qc>September 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 8, 2017</study_first_posted>
  <last_update_submitted>September 19, 2018</last_update_submitted>
  <last_update_submitted_qc>September 19, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 20, 2018</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>Arthritis, Juvenile</mesh_term>
    <mesh_term>Still's Disease, Adult-Onset</mesh_term>
    <mesh_term>Critical Illness</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/NCT03276650
org study id: PSS2017/Still-ICU-LEMARIE/VS
nct id: NCT03276650
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Since its first description in 1971, diagnosing adult-onset Still's disease (AOSD), a rare
      multisystemic disorder considered as a multigenic autoinflammatory syndrome, remains
      challenging. Rarely, AOSD may present severe systemic manifestations and require intensive
      care. The main purpose of the Stil ICU study is to make the first description of the
      epidemiology of critically ill AOSD patients. The investigators will use a retrospective
      cohort study design with dual recruitment strategies: (1) via the AOSD referral centres
      network and (2) via a French academic medical ICU network.
observational model: Cohort
time perspective: Retrospective
measure: number of patients
time frame: At inclusion
description: Number of patients fulfilling the inclusion criteria
measure: APACHE II
time frame: 24hour after ICU admission
description: Acute Physiologic Assessment and Chronic Health Evaluation II
measure: Mortality
time frame: through study completion, maximum 17,5 years after admission
description: Kaplan Meier
measure: Number of rehospitalisation in ICU
time frame: through study completion, maximum 17,5 years after admission
description: need for critical care after the first hospitalisation in ICU
measure: number of hospitalisation in internal medicine ward
time frame: through study completion, maximum 17,5 years after admission
description: number of hospitalisation in internal medicine ward after the first ICU stay
measure: recurrent relapses
time frame: through study completion, maximum 17,5 years after admission
description: number of recurrent flares after the first hospitalisation in ICU
arm group label: critically ill AOSD patients
description: no intervention Data collection from hospitalisation reports (administrative, biological, clinical, outcome)
intervention type: Other
intervention name: data collection
description: biological, administrative, clinical, outcome date
arm group label: critically ill AOSD patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Arthritis, Juvenile
mesh term: Still's Disease, Adult-Onset
mesh term: Critical Illness
sharing ipd: No