<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/NCT04452487</url>
  </required_header>
  <id_info>
    <org_study_id>2020_GUASTELLA_COVID-19-LAT</org_study_id>
    <nct_id>NCT04452487</nct_id>
  </id_info>
  <brief_title>Study of the Consequences of Infection on Compliance of Modalities of Decisions of Limitations and Stops of Treatments (COVID-19-LAT)</brief_title>
  <acronym>COVID-19-LAT</acronym>
  <official_title>Study of the Consequences of Infection on Compliance of Modalities of Decisions of Limitations and Stops of Treatments</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Clermont-Ferrand</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Clermont-Ferrand</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>
      This survey is performed to examine if during the Covid's crisis, the practitionner's have&#xD;
      respected the modalities of the law about the end of life, in particular concerning&#xD;
      limitations and stop of therapeutics&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In the current legislativ context notably the Clayes Leonetti law, a very large majority of&#xD;
      ICU (Intensive Care Unit) patients die with the establishement of a procedure for the&#xD;
      limitation and cessation of therapeutics (LAT). During a viral pandemic, medical resources&#xD;
      can be saturated, limiting reflexive abilities in favour of binary decisions. This sorting of&#xD;
      patients leads to LAT that could be performed without the elementary modalities stated by the&#xD;
      law. Thus, arbitrary medical decisions made alone could expose patients to unjustified &quot; loss&#xD;
      of luck &quot;. Increasing the resources mobilized during a pandemic must not make us forget the&#xD;
      quality of care provided for the benefit of quantity. In therefore seems legitimate to keep&#xD;
      the LAT modalities to ensure our ethical principles. No work in the literature based on&#xD;
      actual facts explores the impact of a pandemic on compliance with and maintenance of ethical&#xD;
      principles and the legisltaive framework, in particular as regards the procedures of the&#xD;
      application of LAT.&#xD;
&#xD;
      The purpose of this study is to assess whether the terms of the LAT are being complied during&#xD;
      a pandemic for patients with or without Covid.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 1, 2020</start_date>
  <completion_date type="Anticipated">June 2021</completion_date>
  <primary_completion_date type="Anticipated">June 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>decisions of limitations and therapeutic stops</measure>
    <time_frame>at the end of patient's hospitalization, an average of one month</time_frame>
    <description>The conformity of the modalities of the decisions of limitations and therapeutic stops will be evaluated by a composite criterion defined by the simultaneous presence of the 3 main modalities imposed by the Clayes-Leonetti law to achieve a limitation that are : An outside consultant's opinion ( required if no advance directives), the caregiver collegial discussion or adherence to patient advance directives, notification of decision in the medical record</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Characteristics of the notification of LAT procedure</measure>
    <time_frame>at the end of patient's hospitalization, an average of one month</time_frame>
    <description>notification of the decision, the conclusions of the discussions, the opinion of the consultant and the arguments given to justify the LAT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Characteristics of the LAT procedure (persons who participated to the collegial discussion)</measure>
    <time_frame>at the end of patient's hospitalization, an average of one month</time_frame>
    <description>number and status of caregivers who participated to the collegial discussion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Characteristics of consultant's reasoned opinion for the LAT procedure</measure>
    <time_frame>at the end of patient's hospitalization, an average of one month</time_frame>
    <description>formal elements of the consultant's reasoned opinion ( legal term) in the file</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Characteristics of the LAT procedure</measure>
    <time_frame>at the end of patient's hospitalization, an average of one month</time_frame>
    <description>formal elements of advance directives</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Characteristics of units</measure>
    <time_frame>day 0</time_frame>
    <description>number of beds, number of caregivers (medical, paramedical, internal external), number of admissions during periods of study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Age of physicians</measure>
    <time_frame>Day 0</time_frame>
    <description>measured in year</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>gendrer of physicians</measure>
    <time_frame>Day 0</time_frame>
    <description>male or female</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Exparience of physicians</measure>
    <time_frame>Day 0</time_frame>
    <description>Measured in year of experience</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Characteristics of physicians</measure>
    <time_frame>Day 0</time_frame>
    <description>professional status</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Age of patients</measure>
    <time_frame>day 0</time_frame>
    <description>measured in year</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>patient's history</measure>
    <time_frame>day 0</time_frame>
    <description>comorbidities</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>COVID-19 patient's status</measure>
    <time_frame>day 0</time_frame>
    <description>COVID19 infection (yes or no)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Characteristics of hospitalization's patients</measure>
    <time_frame>day 0</time_frame>
    <description>hospitalization reason</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Characteristics of affected organ</measure>
    <time_frame>day 0</time_frame>
    <description>organ failure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Characteristics of patients</measure>
    <time_frame>day 0</time_frame>
    <description>severity score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>final patient status</measure>
    <time_frame>day 0</time_frame>
    <description>fate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>patient's environnement</measure>
    <time_frame>day 0</time_frame>
    <description>family presence or relatives</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">2500</enrollment>
  <condition>Patient Hospitalized in Disease Infectious Unit</condition>
  <condition>Patient Hospitalized in Intensive Reanimation Unit</condition>
  <condition>Patient Hopsitalized in Internal Medicine Unit</condition>
  <arm_group>
    <arm_group_label>Patient 2019</arm_group_label>
    <description>Patients hospitalized in selected centers during march and june 2019</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Patient 2020</arm_group_label>
    <description>Patients hospitalized in selected centers during march and june 2020 (during COVID-19 pandemia)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Patient 2021</arm_group_label>
    <description>Patients hospitalized in selected centers during march and june 2021</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>decisions of limitations and stop processing</intervention_name>
    <description>Compliance of the modalities of decisions of limitations and stop processing</description>
    <arm_group_label>Patient 2019</arm_group_label>
    <arm_group_label>Patient 2020</arm_group_label>
    <arm_group_label>Patient 2021</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patient hospitalized in disease infectious Unit, or Patient hospitalized in intensive&#xD;
        reanimation Unit, or Patient hopsitalized in Internal medicine Unit.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Hospitalized major patient&#xD;
&#xD;
          -  Infected or not with Covid-19&#xD;
&#xD;
          -  having a management with a LAT defined by an anticipated or factual restriction of a&#xD;
             therapeutic resource ( organ replacement, specific treatment) while his or her state&#xD;
             of health requires or may require it, leading or not a death. The patient's death&#xD;
             occurs either after a cariac massagewhich corresponds to a maximum management with&#xD;
             therapeutic failure or within the framework or in the context of brain death, in these&#xD;
             cases there is no LAT ; either without cardiac massage and in this case there is de&#xD;
             facto a LAT wether or not it is performed according to legisltaive procedures. All&#xD;
             patients who die will beclassified according to this diagram for the inclusion&#xD;
             criterion. For surviving patients, an analysis of the record in search of LAT elments&#xD;
             will be performed. In the absence of LAT elment in the record, i twill be considered&#xD;
             that the patient did not have LAT and therfore will not be included.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        None&#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>Virginie Guastella</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Clermont-Ferrand</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Lise LACLAUTRE</last_name>
    <phone>+33473754963</phone>
    <email>promo_interne_drci@chu-clermontferrand.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>CHU de Clermont-Ferrand</name>
      <address>
        <city>Clermont-Ferrand</city>
        <zip>63000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lise Laclautre</last_name>
      <phone>+33473754963</phone>
      <email>promo_interne_drci@chu-clermontferrand.fr</email>
    </contact>
    <investigator>
      <last_name>Viginie Guastella</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospices Civiles de Lyon</name>
      <address>
        <city>Lyon</city>
        <zip>69000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Jean-Christophe Richard</last_name>
      <email>j-christophe.richard@chu-lyon.fr</email>
    </contact>
    <investigator>
      <last_name>Jean-Christophe RICHARD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Pascal SEVE</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Laurent ARGAUD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Arnaud HOT</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>André BOIBIEUX</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CH de Vichy</name>
      <address>
        <city>Vichy</city>
        <zip>03000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 23, 2020</study_first_submitted>
  <study_first_submitted_qc>June 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <last_update_submitted>June 26, 2020</last_update_submitted>
  <last_update_submitted_qc>June 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>COVID 19</keyword>
  <keyword>Limitations and stops of processing Active Therapeutic</keyword>
  <keyword>ethics</keyword>
  <keyword>Sanitary Crisis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04452487
org study id: 2020_GUASTELLA_COVID-19-LAT
nct id: NCT04452487
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This survey is performed to examine if during the Covid's crisis, the practitionner's have
      respected the modalities of the law about the end of life, in particular concerning
      limitations and stop of therapeutics
In the current legislativ context notably the Clayes Leonetti law, a very large majority of
      ICU (Intensive Care Unit) patients die with the establishement of a procedure for the
      limitation and cessation of therapeutics (LAT). During a viral pandemic, medical resources
      can be saturated, limiting reflexive abilities in favour of binary decisions. This sorting of
      patients leads to LAT that could be performed without the elementary modalities stated by the
      law. Thus, arbitrary medical decisions made alone could expose patients to unjustified " loss
      of luck ". Increasing the resources mobilized during a pandemic must not make us forget the
      quality of care provided for the benefit of quantity. In therefore seems legitimate to keep
      the LAT modalities to ensure our ethical principles. No work in the literature based on
      actual facts explores the impact of a pandemic on compliance with and maintenance of ethical
      principles and the legisltaive framework, in particular as regards the procedures of the
      application of LAT.

      The purpose of this study is to assess whether the terms of the LAT are being complied during
      a pandemic for patients with or without Covid.
observational model: Case-Control
time perspective: Prospective
measure: decisions of limitations and therapeutic stops
time frame: at the end of patient's hospitalization, an average of one month
description: The conformity of the modalities of the decisions of limitations and therapeutic stops will be evaluated by a composite criterion defined by the simultaneous presence of the 3 main modalities imposed by the Clayes-Leonetti law to achieve a limitation that are : An outside consultant's opinion ( required if no advance directives), the caregiver collegial discussion or adherence to patient advance directives, notification of decision in the medical record
measure: Characteristics of the notification of LAT procedure
time frame: at the end of patient's hospitalization, an average of one month
description: notification of the decision, the conclusions of the discussions, the opinion of the consultant and the arguments given to justify the LAT
measure: Characteristics of the LAT procedure (persons who participated to the collegial discussion)
time frame: at the end of patient's hospitalization, an average of one month
description: number and status of caregivers who participated to the collegial discussion
measure: Characteristics of consultant's reasoned opinion for the LAT procedure
time frame: at the end of patient's hospitalization, an average of one month
description: formal elements of the consultant's reasoned opinion ( legal term) in the file
measure: Characteristics of the LAT procedure
time frame: at the end of patient's hospitalization, an average of one month
description: formal elements of advance directives
measure: Characteristics of units
time frame: day 0
description: number of beds, number of caregivers (medical, paramedical, internal external), number of admissions during periods of study
measure: Age of physicians
time frame: Day 0
description: measured in year
measure: gendrer of physicians
time frame: Day 0
description: male or female
measure: Exparience of physicians
time frame: Day 0
description: Measured in year of experience
measure: Characteristics of physicians
time frame: Day 0
description: professional status
measure: Age of patients
time frame: day 0
description: measured in year
measure: patient's history
time frame: day 0
description: comorbidities
measure: COVID-19 patient's status
time frame: day 0
description: COVID19 infection (yes or no)
measure: Characteristics of hospitalization's patients
time frame: day 0
description: hospitalization reason
measure: Characteristics of affected organ
time frame: day 0
description: organ failure
measure: Characteristics of patients
time frame: day 0
description: severity score
measure: final patient status
time frame: day 0
description: fate
measure: patient's environnement
time frame: day 0
description: family presence or relatives
arm group label: Patient 2019
description: Patients hospitalized in selected centers during march and june 2019
arm group label: Patient 2020
description: Patients hospitalized in selected centers during march and june 2020 (during COVID-19 pandemia)
arm group label: Patient 2021
description: Patients hospitalized in selected centers during march and june 2021
intervention type: Behavioral
intervention name: decisions of limitations and stop processing
description: Compliance of the modalities of decisions of limitations and stop processing
arm group label: Patient 2019
arm group label: Patient 2020
arm group label: Patient 2021
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Virginie Guastella
role: Principal Investigator
affiliation: University Hospital, Clermont-Ferrand
last name: Lise LACLAUTRE
phone: +33473754963
email: promo_interne_drci@chu-clermontferrand.fr
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
facility: 
status: Not yet recruiting
country: France
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases