<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/NCT03021564</url>
  </required_header>
  <id_info>
    <org_study_id>2015/P04/049</org_study_id>
    <nct_id>NCT03021564</nct_id>
  </id_info>
  <brief_title>Unexpected Cardiac Arrest in Intensive Care Unit</brief_title>
  <acronym>ACIR</acronym>
  <official_title>Prospective Multi-centre Observational Study on the Epidemiology, Risk Factors and Consequences of Unexpected Cardiac Arrest in Intensive Care Units.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Groupe Hospitalier de la Rochelle Ré Aunis</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Groupe Hospitalier de la Rochelle Ré Aunis</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Unexpected cardiac arrest involves approximately 0.5 to 5% of patients admitted in Intensive&#xD;
      Care Unit (ICU). Even if they have a technical environment conducive to prompt diagnosis and&#xD;
      prompt treatment, patients hospitalized in ICU suffer from chronic illnesses and organ&#xD;
      failure(s) that obscure the prognosis of cardiac arrest. Although extra cardiac arrhythmias&#xD;
      or intra-hospital arrests are the subject of numerous publications, few studies specifically&#xD;
      focus on unexpected cardiac arrest in ICU (none in France). The objective of our work is to&#xD;
      produce a prospective epidemiological description of unexpected cardiac arrest in in French&#xD;
      ICUs.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Unexpected cardiac arrest in ICU corresponds to cardiovascular arrest leading to at least one&#xD;
      cardiopulmonary resuscitation technique (external cardiac massage and / or electric shock).&#xD;
      They account for about 0.5 to 5% of admissions to intensive care units. Even if they benefit&#xD;
      from a technical environment conducive to prompt diagnosis and rapid management, Resuscitated&#xD;
      patients suffer from chronic diseases and organ failure (s) that darken the prognosis.&#xD;
      Etiologies of unexpected cardiac arrest in ICU are rarely described in the literature. Their&#xD;
      specificity comes from the fact that they can be related to patient's medical&#xD;
      characteristics, but also to deleterious effects of supportive techniques in place at the&#xD;
      time of circulatory arrest (respiratory assistance, vasopressor drugs, extracorporeal&#xD;
      circulation ...). These same techniques may also reduce the effectiveness of cardiopulmonary&#xD;
      resuscitation (cardiorespiratory interactions of respiratory assistance, pro-arrhythmogenic&#xD;
      effect of vasopressor drugs, haemodynamic repercussion of extracorporeal circulation).&#xD;
      Although cardiac arrests have been published extensively out of or in-hospital, there are few&#xD;
      studies specifically concerning unexpected cardiac arrest in ICU (none in France). The&#xD;
      prognosis is different: after an unexpected cardiac arrest in ICU, 50% of the patients&#xD;
      recover a spontaneous cardiac activity but only 15% leave alive from the hospital (3 to 4%&#xD;
      with a good functional autonomy). A prospective description of risk factors, circumstances&#xD;
      and consequences in the medium term would identify (and prevent) risky situations and&#xD;
      identify, among those at risk for unexpected cardiac arrest, those for whom a cardiopulmonary&#xD;
      resuscitation is justified.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">June 2018</completion_date>
  <primary_completion_date type="Actual">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>Number of Patients With Unexpected Cardiac Arrest</measure>
    <time_frame>1 year</time_frame>
    <description>Number of patients with at least one cardiac arrest in intensive care with attempted cardiopulmonary resuscitation as a proportion of total admissions.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Patients Per Reason for ICU Admission</measure>
    <time_frame>1 year</time_frame>
    <description>Number of patients admitted to ICU with either Medical (vs surgical) reason for admission, circulatory failure, respiratory failure, cardiac arrest, cardiac surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>History, Comorbidities Before Unexpected Cardiac Arrest</measure>
    <time_frame>1 year</time_frame>
    <description>High blood pressure, Diabetes, Dyslipidemia, Tobacco, Ischemic heart disease, Heart disease from another cause, Malignancy, Alcohol, Renal disease, Respiratory disease, Cardiac arrest, Neurological disease, Liver disease</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mc Cabe Score Before Unexpected Cardiac Arrest</measure>
    <time_frame>1 year</time_frame>
    <description>0- absence of underlying disease or non-life-threatening disease&#xD;
underlying life-threatening disease over a period of 5 years&#xD;
underlying disease estimated fatal within 1 year</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Knaus Score Before Unexpected Cardiac Arrest</measure>
    <time_frame>1 year</time_frame>
    <description>A- No activity limitation B- Moderate restriction of activity (limited professional activities) C- Major activity restriction but not total D- Major activity restriction, bedridden condition, long-term hospitalization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Organ Failure Score Before Unexpected Cardiac Arrest</measure>
    <time_frame>1 year</time_frame>
    <description>sequential organ failure assessment (SOFA) sub-score ≥ 3&#xD;
Respiratory failure: &lt; 200 fraction of inspired oxygen inspired oxygen fraction (26.7 mmHg [kilopascal]) and mechanically ventilated,&#xD;
Neurological impairment : Glasgow coma scale &lt;10,&#xD;
Circulatory failure: dopamine &gt; 5 μg/kg/min OR epinephrine ≤ 0.1 μg/kg/min OR norepinephrine ≤ 0.1 μg/kg/min,&#xD;
Hepatic failure: ≥ 6.0-11.9 mg/dl [102-204 μmol/L] Bilirubin,&#xD;
Haematological failure: &lt; 50 Platelets×103/μl,&#xD;
Renal failure: ≥ 3.5-4.9 mg/dl [300-44 0μmol/L] (or &lt; 500 ml/d) Creatinine</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Unexpected Cardiac Arrest Etiologies</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Patients With Resumption of Spontaneous Cardiac Activity After Cardiopulmonary Resuscitation</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cerebral Performance Category Scale at Hospital Discharge</measure>
    <time_frame>at Hospital Discharge</time_frame>
    <description>Cerebral performance category score (CPC)&#xD;
Conscious without neurological deficit or minor deficit&#xD;
Conscious with moderate deficit&#xD;
Conscious with severe deficit&#xD;
Deep Coma or Vegetative State&#xD;
Deceased</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cerebral Performance Category Scale at 6 Months</measure>
    <time_frame>at 6 months after inclusion (unexpected cardiac arrest)</time_frame>
    <description>Cerebral performance category score (CPC)&#xD;
Conscious without neurological deficit or minor deficit&#xD;
Conscious with moderate deficit&#xD;
Conscious with severe deficit&#xD;
Deep Coma or Vegetative State&#xD;
Deceased</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Patients With Unexpected Cardiac Arrest, Resuscitated Despite Previous Decision Not to Resuscitate</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">677</enrollment>
  <condition>Heart Arrest</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>cardiopulmonary resuscitation</intervention_name>
    <description>Basic cardiopulmonary resuscitation : external electric shock, external cardiac massage, adrenaline injection ...</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients admitted in intensive care unit during the study period and presenting an&#xD;
        unexpected cardiac arrest will be included&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient with unexpected cardiac arrest during his / her hospitalization in the ICU&#xD;
&#xD;
          -  Patients who have benefited from at least one basic cardiopulmonary resuscitation&#xD;
             technique by the ICU team to treat this circulatory arrest (external electric shock,&#xD;
             external cardiac massage, adrenaline injection ...)&#xD;
&#xD;
          -  Patients with multiple unexpected cardiac arrest during hospitalization will be&#xD;
             included only for the first circulatory arrest.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with unexpected cardiac that have not been resuscitated.&#xD;
&#xD;
          -  Patients in cardiac arrest at admission to ICU&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Maxime Leloup, MD</last_name>
    <role>Study Director</role>
    <affiliation>Groupe Hospitalier de la Rochelle Ré Aunis</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CH Agen</name>
      <address>
        <city>Agen</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Angers</name>
      <address>
        <city>Angers</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH Angouleme</name>
      <address>
        <city>Angouleme</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH Angoulême</name>
      <address>
        <city>Angouleme</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH Arras</name>
      <address>
        <city>Arras</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GH Carnelle Portes de l'Oise</name>
      <address>
        <city>Beaumont</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH Béthune</name>
      <address>
        <city>Bethune</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH Blois</name>
      <address>
        <city>Blois</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>APHP</name>
      <address>
        <city>Bobigny</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH Bourg en Bresse</name>
      <address>
        <city>Bourg en Bresse</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Brest</name>
      <address>
        <city>Brest</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Caen</name>
      <address>
        <city>Caen</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH Cahors</name>
      <address>
        <city>Cahors</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH Chartres</name>
      <address>
        <city>Chartres</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH Cholet</name>
      <address>
        <city>Cholet</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH Colmar</name>
      <address>
        <city>Colmar</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH Dieppe</name>
      <address>
        <city>Dieppe</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Dijon</name>
      <address>
        <city>Dijon</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH Sud Essonnes</name>
      <address>
        <city>Etampes</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>APHP</name>
      <address>
        <city>Garches</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Grenoble</name>
      <address>
        <city>Grenoble</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH Gueret</name>
      <address>
        <city>Gueret</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHD Vendée</name>
      <address>
        <city>La Roche sur Yon</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GH La Rochelle Ré Aunis</name>
      <address>
        <city>La Rochelle</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU La Réunion</name>
      <address>
        <city>La Réunion</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH Lens</name>
      <address>
        <city>Lens</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GH de l'Institut Catholique de Lille</name>
      <address>
        <city>Lille</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Limoges</name>
      <address>
        <city>Limoges</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Lyon</name>
      <address>
        <city>Lyon</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH Meaux</name>
      <address>
        <city>Meaux</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH Melun</name>
      <address>
        <city>Melun</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Nantes</name>
      <address>
        <city>Nantes</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH Niort</name>
      <address>
        <city>Niort</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Nîmes</name>
      <address>
        <city>Nîmes</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHR Orleans</name>
      <address>
        <city>Orleans</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>APHP Cochin</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>APHP Saint Louis</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Paris Saint Joseph</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH Pau</name>
      <address>
        <city>Pau</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Poitiers</name>
      <address>
        <city>Poitiers</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH Pontoise</name>
      <address>
        <city>Pontoise</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH Cornouaille</name>
      <address>
        <city>Quimper</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH Roanne</name>
      <address>
        <city>Roanne</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Rouen</name>
      <address>
        <city>Rouen</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CH Versailles</name>
      <address>
        <city>Versailles</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
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  </reference>
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    <citation>Efendijev I, Raj R, Reinikainen M, Hoppu S, Skrifvars MB. Temporal trends in cardiac arrest incidence and outcome in Finnish intensive care units from 2003 to 2013. Intensive Care Med. 2014 Dec;40(12):1853-61. doi: 10.1007/s00134-014-3509-z. Epub 2014 Nov 12.</citation>
    <PMID>25387815</PMID>
  </reference>
  <reference>
    <citation>Vincent JL, Moreno R, Takala J, Willatts S, De Mendonca A, Bruining H, Reinhart CK, Suter PM, Thijs LG. The SOFA (Sepsis-related Organ Failure Assessment) score to describe organ dysfunction/failure. On behalf of the Working Group on Sepsis-Related Problems of the European Society of Intensive Care Medicine. Intensive Care Med. 1996 Jul;22(7):707-10. doi: 10.1007/BF01709751. No abstract available.</citation>
    <PMID>8844239</PMID>
  </reference>
  <reference>
    <citation>Lesieur O, Leloup M, Gonzalez F, Mamzer MF; EPILAT study group. Withholding or withdrawal of treatment under French rules: a study performed in 43 intensive care units. Ann Intensive Care. 2015 Dec;5(1):56. doi: 10.1186/s13613-015-0056-x. Epub 2015 Jun 19.</citation>
    <PMID>26092498</PMID>
  </reference>
  <results_reference>
    <citation>Leloup M, Briatte I, Langlois A, Cariou A, Lesieur O; ACIR study group. Unexpected cardiac arrests occurring inside the ICU: outcomes of a French prospective multicenter study. Intensive Care Med. 2020 May;46(5):1005-1015. doi: 10.1007/s00134-020-05992-w. Epub 2020 Mar 9.</citation>
    <PMID>32152653</PMID>
  </results_reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>January 10, 2017</study_first_submitted>
  <study_first_submitted_qc>January 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 16, 2017</study_first_posted>
  <results_first_submitted>July 7, 2020</results_first_submitted>
  <results_first_submitted_qc>July 31, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">August 17, 2020</results_first_posted>
  <last_update_submitted>July 31, 2020</last_update_submitted>
  <last_update_submitted_qc>July 31, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 17, 2020</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>Heart Arrest</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol, Statistical Analysis Plan, and Informed Consent Form</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>January 11, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/64/NCT03021564/Prot_SAP_ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>31,399 patients were admitted to intensive care unit (ICU), 24,245 were discharged alive without in-ICU cardiac arrest, 6,477 died in the ICU with no cardiopulmonary resuscitation (CPR) attempt, 677 had cardiac arrest with CPR attempt.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Shockable Rhythms</title>
          <description>Patients with documented shockable rhythms during cardiac arrest</description>
        </group>
        <group group_id="P2">
          <title>Non-shockable Rhythms</title>
          <description>Patients with documented non-shockable rhythms during cardiac arrest</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="120"/>
                <participants group_id="P2" count="557"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="36"/>
                <participants group_id="P2" count="89"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="84"/>
                <participants group_id="P2" count="468"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="84"/>
                <participants group_id="P2" count="466"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Shockable Rhythms</title>
          <description>Patients with documented shockable rhythms during cardiac arrest</description>
        </group>
        <group group_id="B2">
          <title>Non-shockable Rhythms</title>
          <description>Patients with documented non-shockable rhythms during cardiac arrest</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="120"/>
            <count group_id="B2" value="557"/>
            <count group_id="B3" value="677"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <title>Age</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="120"/>
                    <count group_id="B2" value="557"/>
                    <count group_id="B3" value="677"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="71" lower_limit="60" upper_limit="78"/>
                    <measurement group_id="B2" value="69" lower_limit="60" upper_limit="78"/>
                    <measurement group_id="B3" value="69" lower_limit="60" upper_limit="77"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="120"/>
                    <count group_id="B2" value="557"/>
                    <count group_id="B3" value="677"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                    <measurement group_id="B2" value="175"/>
                    <measurement group_id="B3" value="210"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="85"/>
                    <measurement group_id="B2" value="382"/>
                    <measurement group_id="B3" value="467"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>France</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="120"/>
                    <count group_id="B2" value="557"/>
                    <count group_id="B3" value="677"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="120"/>
                    <measurement group_id="B2" value="557"/>
                    <measurement group_id="B3" value="677"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Patients With Unexpected Cardiac Arrest</title>
        <description>Number of patients with at least one cardiac arrest in intensive care with attempted cardiopulmonary resuscitation as a proportion of total admissions.</description>
        <time_frame>1 year</time_frame>
        <population>Screening of all inpatients in the ICU during the study period. Only in-ICU cardiac arrest with attempted CPR are included in the study</population>
        <group_list>
          <group group_id="O1">
            <title>In-ICU Admissions</title>
            <description>Patients admitted in 45 participating intensive care unit (ICU) over one year</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients With Unexpected Cardiac Arrest</title>
          <description>Number of patients with at least one cardiac arrest in intensive care with attempted cardiopulmonary resuscitation as a proportion of total admissions.</description>
          <population>Screening of all inpatients in the ICU during the study period. Only in-ICU cardiac arrest with attempted CPR are included in the study</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31,399"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>in-ICU cardiac arrest with attempted CPR</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="677"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No attempted CPR</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30,722"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Patients Per Reason for ICU Admission</title>
        <description>Number of patients admitted to ICU with either Medical (vs surgical) reason for admission, circulatory failure, respiratory failure, cardiac arrest, cardiac surgery</description>
        <time_frame>1 year</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Shockable Rhythms</title>
            <description>Patients with documented shockable rhythms during cardiac arrest</description>
          </group>
          <group group_id="O2">
            <title>Non-shockable Rhythms</title>
            <description>Patients with documented non-shockable rhythms during cardiac arrest</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients Per Reason for ICU Admission</title>
          <description>Number of patients admitted to ICU with either Medical (vs surgical) reason for admission, circulatory failure, respiratory failure, cardiac arrest, cardiac surgery</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="120"/>
                <count group_id="O2" value="557"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Medical (vs surgical) reason for admission</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="100"/>
                    <measurement group_id="O2" value="487"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Circulatory failure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37"/>
                    <measurement group_id="O2" value="210"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Respiratory failure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22"/>
                    <measurement group_id="O2" value="149"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cardiac arrest</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31"/>
                    <measurement group_id="O2" value="69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cardiac surgery</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>History, Comorbidities Before Unexpected Cardiac Arrest</title>
        <description>High blood pressure, Diabetes, Dyslipidemia, Tobacco, Ischemic heart disease, Heart disease from another cause, Malignancy, Alcohol, Renal disease, Respiratory disease, Cardiac arrest, Neurological disease, Liver disease</description>
        <time_frame>1 year</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Shockable Rhythms</title>
            <description>Patients with documented shockable rhythms during cardiac arrest</description>
          </group>
          <group group_id="O2">
            <title>Non-shockable Rhythms</title>
            <description>Patients with documented non-shockable rhythms during cardiac arrest</description>
          </group>
        </group_list>
        <measure>
          <title>History, Comorbidities Before Unexpected Cardiac Arrest</title>
          <description>High blood pressure, Diabetes, Dyslipidemia, Tobacco, Ischemic heart disease, Heart disease from another cause, Malignancy, Alcohol, Renal disease, Respiratory disease, Cardiac arrest, Neurological disease, Liver disease</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="120"/>
                <count group_id="O2" value="557"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>High blood pressure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75"/>
                    <measurement group_id="O2" value="322"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Diabetes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37"/>
                    <measurement group_id="O2" value="182"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dyslipidemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47"/>
                    <measurement group_id="O2" value="156"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Tobacco</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="37"/>
                    <measurement group_id="O2" value="164"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ischemic heart disease</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52"/>
                    <measurement group_id="O2" value="137"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Heart disease from another cause</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35"/>
                    <measurement group_id="O2" value="106"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Malignancy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="153"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Alcohol</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="105"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Renal disease</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="105"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Respiratory disease</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="103"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cardiac arrest</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="41"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neurological disease</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Liver disease</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mc Cabe Score Before Unexpected Cardiac Arrest</title>
        <description>0- absence of underlying disease or non-life-threatening disease&#xD;
underlying life-threatening disease over a period of 5 years&#xD;
underlying disease estimated fatal within 1 year</description>
        <time_frame>1 year</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Shockable Rhythms</title>
            <description>Patients with documented shockable rhythms during cardiac arrest</description>
          </group>
          <group group_id="O2">
            <title>Non-shockable Rhythms</title>
            <description>Patients with documented non-shockable rhythms during cardiac arrest</description>
          </group>
        </group_list>
        <measure>
          <title>Mc Cabe Score Before Unexpected Cardiac Arrest</title>
          <description>0- absence of underlying disease or non-life-threatening disease&#xD;
underlying life-threatening disease over a period of 5 years&#xD;
underlying disease estimated fatal within 1 year</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="120"/>
                <count group_id="O2" value="557"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>McCabe 0 (no fatal disease)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="63"/>
                    <measurement group_id="O2" value="269"/>
                  </measurement_list>
                </category>
                <category>
                  <title>McCabe 1 or 2</title>
                  <measurement_list>
                    <measurement group_id="O1" value="57"/>
                    <measurement group_id="O2" value="288"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Knaus Score Before Unexpected Cardiac Arrest</title>
        <description>A- No activity limitation B- Moderate restriction of activity (limited professional activities) C- Major activity restriction but not total D- Major activity restriction, bedridden condition, long-term hospitalization</description>
        <time_frame>1 year</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Shockable Rhythms</title>
            <description>Patients with documented shockable rhythms during cardiac arrest</description>
          </group>
          <group group_id="O2">
            <title>Non-shockable Rhythms</title>
            <description>Patients with documented non-shockable rhythms during cardiac arrest</description>
          </group>
        </group_list>
        <measure>
          <title>Knaus Score Before Unexpected Cardiac Arrest</title>
          <description>A- No activity limitation B- Moderate restriction of activity (limited professional activities) C- Major activity restriction but not total D- Major activity restriction, bedridden condition, long-term hospitalization</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="120"/>
                <count group_id="O2" value="557"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Knaus A or B (no or moderate limitation)</title>
                  <measurement_list>
                    <measurement group_id="O1" value="92"/>
                    <measurement group_id="O2" value="392"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Knaus C or D</title>
                  <measurement_list>
                    <measurement group_id="O1" value="28"/>
                    <measurement group_id="O2" value="165"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Organ Failure Score Before Unexpected Cardiac Arrest</title>
        <description>sequential organ failure assessment (SOFA) sub-score ≥ 3&#xD;
Respiratory failure: &lt; 200 fraction of inspired oxygen inspired oxygen fraction (26.7 mmHg [kilopascal]) and mechanically ventilated,&#xD;
Neurological impairment : Glasgow coma scale &lt;10,&#xD;
Circulatory failure: dopamine &gt; 5 μg/kg/min OR epinephrine ≤ 0.1 μg/kg/min OR norepinephrine ≤ 0.1 μg/kg/min,&#xD;
Hepatic failure: ≥ 6.0-11.9 mg/dl [102-204 μmol/L] Bilirubin,&#xD;
Haematological failure: &lt; 50 Platelets×103/μl,&#xD;
Renal failure: ≥ 3.5-4.9 mg/dl [300-44 0μmol/L] (or &lt; 500 ml/d) Creatinine</description>
        <time_frame>1 year</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Shockable Rhythms</title>
            <description>Patients with documented shockable rhythms during cardiac arrest</description>
          </group>
          <group group_id="O2">
            <title>Non-shockable Rhythms</title>
            <description>Patients with documented non-shockable rhythms during cardiac arrest</description>
          </group>
        </group_list>
        <measure>
          <title>Organ Failure Score Before Unexpected Cardiac Arrest</title>
          <description>sequential organ failure assessment (SOFA) sub-score ≥ 3&#xD;
Respiratory failure: &lt; 200 fraction of inspired oxygen inspired oxygen fraction (26.7 mmHg [kilopascal]) and mechanically ventilated,&#xD;
Neurological impairment : Glasgow coma scale &lt;10,&#xD;
Circulatory failure: dopamine &gt; 5 μg/kg/min OR epinephrine ≤ 0.1 μg/kg/min OR norepinephrine ≤ 0.1 μg/kg/min,&#xD;
Hepatic failure: ≥ 6.0-11.9 mg/dl [102-204 μmol/L] Bilirubin,&#xD;
Haematological failure: &lt; 50 Platelets×103/μl,&#xD;
Renal failure: ≥ 3.5-4.9 mg/dl [300-44 0μmol/L] (or &lt; 500 ml/d) Creatinine</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="120"/>
                <count group_id="O2" value="557"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Respiratory failure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42"/>
                    <measurement group_id="O2" value="195"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Neurological impairment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48"/>
                    <measurement group_id="O2" value="177"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Circulatory failure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="68"/>
                    <measurement group_id="O2" value="269"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hepatic failure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26"/>
                    <measurement group_id="O2" value="168"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Haematological failure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Renal failure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Unexpected Cardiac Arrest Etiologies</title>
        <time_frame>1 year</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Shockable Rhythms</title>
            <description>Patients with documented shockable rhythms during cardiac arrest</description>
          </group>
          <group group_id="O2">
            <title>Non-shockable Rhythms</title>
            <description>Patients with documented non-shockable rhythms during cardiac arrest</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Unexpected Cardiac Arrest Etiologies</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="120"/>
                <count group_id="O2" value="557"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>At least one cause ultimately identified</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="91"/>
                    <measurement group_id="O2" value="445"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypoxia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="164"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Metabolic disorder</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30"/>
                    <measurement group_id="O2" value="92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypovolemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Attributed to the life-sustaining device(s)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11"/>
                    <measurement group_id="O2" value="87"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Respiratory support</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Circulatory assistance</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Medications</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3"/>
                    <measurement group_id="O2" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Patients With Resumption of Spontaneous Cardiac Activity After Cardiopulmonary Resuscitation</title>
        <time_frame>1 year</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Shockable Rhythms</title>
            <description>Patients with documented shockable rhythms during cardiac arrest</description>
          </group>
          <group group_id="O2">
            <title>Non-shockable Rhythms</title>
            <description>Patients with documented non-shockable rhythms during cardiac arrest</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients With Resumption of Spontaneous Cardiac Activity After Cardiopulmonary Resuscitation</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="120"/>
                <count group_id="O2" value="557"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>return of spontaneous circulation ≥ 20 min</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="97"/>
                    <measurement group_id="O2" value="381"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>return of spontaneous circulation ≥ 24 h</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="73"/>
                    <measurement group_id="O2" value="223"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cerebral Performance Category Scale at Hospital Discharge</title>
        <description>Cerebral performance category score (CPC)&#xD;
Conscious without neurological deficit or minor deficit&#xD;
Conscious with moderate deficit&#xD;
Conscious with severe deficit&#xD;
Deep Coma or Vegetative State&#xD;
Deceased</description>
        <time_frame>at Hospital Discharge</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Shockable Rhythms and Alive at Hospital Discharge</title>
            <description>Patients with documented shockable rhythms during cardiac arrest and alive at hospital discharge</description>
          </group>
          <group group_id="O2">
            <title>Non-shockable Rhythms and Alive at Hospital Discharge</title>
            <description>Patients with documented non-shockable rhythms during cardiac arrest and alive at hospital discharge</description>
          </group>
        </group_list>
        <measure>
          <title>Cerebral Performance Category Scale at Hospital Discharge</title>
          <description>Cerebral performance category score (CPC)&#xD;
Conscious without neurological deficit or minor deficit&#xD;
Conscious with moderate deficit&#xD;
Conscious with severe deficit&#xD;
Deep Coma or Vegetative State&#xD;
Deceased</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="44"/>
                <count group_id="O2" value="102"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>CPC 1 or 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43"/>
                    <measurement group_id="O2" value="92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CPC 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CPC 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cerebral Performance Category Scale at 6 Months</title>
        <description>Cerebral performance category score (CPC)&#xD;
Conscious without neurological deficit or minor deficit&#xD;
Conscious with moderate deficit&#xD;
Conscious with severe deficit&#xD;
Deep Coma or Vegetative State&#xD;
Deceased</description>
        <time_frame>at 6 months after inclusion (unexpected cardiac arrest)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Shockable Rhythms and Alive at 6-month Follow-up</title>
            <description>Patients with documented shockable rhythms during cardiac arrest and alive at 6-month follow-up</description>
          </group>
          <group group_id="O2">
            <title>Non-shockable Rhythms and Alive at 6-month Follow-up</title>
            <description>Patients with documented non-shockable rhythms during cardiac arrest and alive at 6-month follow-up</description>
          </group>
        </group_list>
        <measure>
          <title>Cerebral Performance Category Scale at 6 Months</title>
          <description>Cerebral performance category score (CPC)&#xD;
Conscious without neurological deficit or minor deficit&#xD;
Conscious with moderate deficit&#xD;
Conscious with severe deficit&#xD;
Deep Coma or Vegetative State&#xD;
Deceased</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="36"/>
                <count group_id="O2" value="89"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>CPC 1 or 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36"/>
                    <measurement group_id="O2" value="82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CPC 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>CPC 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Patients With Unexpected Cardiac Arrest, Resuscitated Despite Previous Decision Not to Resuscitate</title>
        <time_frame>1 year</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Shockable Rhythms</title>
            <description>Patients with documented shockable rhythms during cardiac arrest</description>
          </group>
          <group group_id="O2">
            <title>Non-shockable Rhythms</title>
            <description>Patients with documented non-shockable rhythms during cardiac arrest</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients With Unexpected Cardiac Arrest, Resuscitated Despite Previous Decision Not to Resuscitate</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="120"/>
                <count group_id="O2" value="557"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>6-month follow up</time_frame>
      <group_list>
        <group group_id="E1">
          <title>In-ICU Admissions</title>
          <description>Patients admitted in 45 participating intensive care unit (ICU) over one year</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 10.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="550" subjects_at_risk="677"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="677"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Conscious with severe deficit</sub_title>
                <counts group_id="E1" events="20" subjects_affected="7" subjects_at_risk="677"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA 10.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="118" subjects_at_risk="677"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Conscious without neurological deficit, minor or moderate deficit</sub_title>
                <counts group_id="E1" events="143" subjects_affected="118" subjects_at_risk="677"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr Maxime Leloup</name_or_title>
      <organization>Groupe Hospitalier de la Rochelle Ré Aunis</organization>
      <phone>+33 (0)5 46 45 66 09</phone>
      <email>maxime.leloup@ght-atlantique17.fr</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03021564
org study id: 2015/P04/049
nct id: NCT03021564
lead sponsor: 
has dmc: No
Unexpected cardiac arrest involves approximately 0.5 to 5% of patients admitted in Intensive
      Care Unit (ICU). Even if they have a technical environment conducive to prompt diagnosis and
      prompt treatment, patients hospitalized in ICU suffer from chronic illnesses and organ
      failure(s) that obscure the prognosis of cardiac arrest. Although extra cardiac arrhythmias
      or intra-hospital arrests are the subject of numerous publications, few studies specifically
      focus on unexpected cardiac arrest in ICU (none in France). The objective of our work is to
      produce a prospective epidemiological description of unexpected cardiac arrest in in French
      ICUs.
Unexpected cardiac arrest in ICU corresponds to cardiovascular arrest leading to at least one
      cardiopulmonary resuscitation technique (external cardiac massage and / or electric shock).
      They account for about 0.5 to 5% of admissions to intensive care units. Even if they benefit
      from a technical environment conducive to prompt diagnosis and rapid management, Resuscitated
      patients suffer from chronic diseases and organ failure (s) that darken the prognosis.
      Etiologies of unexpected cardiac arrest in ICU are rarely described in the literature. Their
      specificity comes from the fact that they can be related to patient's medical
      characteristics, but also to deleterious effects of supportive techniques in place at the
      time of circulatory arrest (respiratory assistance, vasopressor drugs, extracorporeal
      circulation ...). These same techniques may also reduce the effectiveness of cardiopulmonary
      resuscitation (cardiorespiratory interactions of respiratory assistance, pro-arrhythmogenic
      effect of vasopressor drugs, haemodynamic repercussion of extracorporeal circulation).
      Although cardiac arrests have been published extensively out of or in-hospital, there are few
      studies specifically concerning unexpected cardiac arrest in ICU (none in France). The
      prognosis is different: after an unexpected cardiac arrest in ICU, 50% of the patients
      recover a spontaneous cardiac activity but only 15% leave alive from the hospital (3 to 4%
      with a good functional autonomy). A prospective description of risk factors, circumstances
      and consequences in the medium term would identify (and prevent) risky situations and
      identify, among those at risk for unexpected cardiac arrest, those for whom a cardiopulmonary
      resuscitation is justified.
observational model: Cohort
time perspective: Prospective
measure: Number of Patients With Unexpected Cardiac Arrest
time frame: 1 year
description: Number of patients with at least one cardiac arrest in intensive care with attempted cardiopulmonary resuscitation as a proportion of total admissions.
measure: Number of Patients Per Reason for ICU Admission
time frame: 1 year
description: Number of patients admitted to ICU with either Medical (vs surgical) reason for admission, circulatory failure, respiratory failure, cardiac arrest, cardiac surgery
measure: History, Comorbidities Before Unexpected Cardiac Arrest
time frame: 1 year
description: High blood pressure, Diabetes, Dyslipidemia, Tobacco, Ischemic heart disease, Heart disease from another cause, Malignancy, Alcohol, Renal disease, Respiratory disease, Cardiac arrest, Neurological disease, Liver disease
measure: Mc Cabe Score Before Unexpected Cardiac Arrest
time frame: 1 year
description: 0- absence of underlying disease or non-life-threatening disease
underlying life-threatening disease over a period of 5 years
underlying disease estimated fatal within 1 year
measure: Knaus Score Before Unexpected Cardiac Arrest
time frame: 1 year
description: A- No activity limitation B- Moderate restriction of activity (limited professional activities) C- Major activity restriction but not total D- Major activity restriction, bedridden condition, long-term hospitalization
measure: Organ Failure Score Before Unexpected Cardiac Arrest
time frame: 1 year
description: sequential organ failure assessment (SOFA) sub-score ≥ 3
Respiratory failure: < 200 fraction of inspired oxygen inspired oxygen fraction (26.7 mmHg [kilopascal]) and mechanically ventilated,
Neurological impairment : Glasgow coma scale <10,
Circulatory failure: dopamine > 5 μg/kg/min OR epinephrine ≤ 0.1 μg/kg/min OR norepinephrine ≤ 0.1 μg/kg/min,
Hepatic failure: ≥ 6.0-11.9 mg/dl [102-204 μmol/L] Bilirubin,
Haematological failure: < 50 Platelets×103/μl,
Renal failure: ≥ 3.5-4.9 mg/dl [300-44 0μmol/L] (or < 500 ml/d) Creatinine
measure: Number of Participants With Unexpected Cardiac Arrest Etiologies
time frame: 1 year
measure: Number of Patients With Resumption of Spontaneous Cardiac Activity After Cardiopulmonary Resuscitation
time frame: 1 year
measure: Cerebral Performance Category Scale at Hospital Discharge
time frame: at Hospital Discharge
description: Cerebral performance category score (CPC)
Conscious without neurological deficit or minor deficit
Conscious with moderate deficit
Conscious with severe deficit
Deep Coma or Vegetative State
Deceased
measure: Cerebral Performance Category Scale at 6 Months
time frame: at 6 months after inclusion (unexpected cardiac arrest)
description: Cerebral performance category score (CPC)
Conscious without neurological deficit or minor deficit
Conscious with moderate deficit
Conscious with severe deficit
Deep Coma or Vegetative State
Deceased
measure: Number of Patients With Unexpected Cardiac Arrest, Resuscitated Despite Previous Decision Not to Resuscitate
time frame: 1 year
intervention type: Other
intervention name: cardiopulmonary resuscitation
description: Basic cardiopulmonary resuscitation : external electric shock, external cardiac massage, adrenaline injection ...
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Maxime Leloup, MD
role: Study Director
affiliation: Groupe Hospitalier de la Rochelle Ré Aunis
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country: France
citation: Rozen TH, Mullane S, Kaufman M, Hsiao YF, Warrillow S, Bellomo R, Jones DA. Antecedents to cardiac arrests in a teaching hospital intensive care unit. Resuscitation. 2014 Mar;85(3):411-7. doi: 10.1016/j.resuscitation.2013.11.018. Epub 2013 Dec 8.
PMID: 24326274
citation: Knaus WA, Zimmerman JE, Wagner DP, Draper EA, Lawrence DE. APACHE-acute physiology and chronic health evaluation: a physiologically based classification system. Crit Care Med. 1981 Aug;9(8):591-7. doi: 10.1097/00003246-198108000-00008.
PMID: 7261642
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responsible party type: Sponsor
mesh term: Heart Arrest
sharing ipd: Undecided
provided document: 
participant flow: 
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outcome list: 
reported events: 
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