Clinical trial NCT04452487: Study of the Consequences of Infection on Compliance of Modalities of Decisions of Limitations and Stops of Treatments (COVID-19-LAT)
Official title: Study of the Consequences of Infection on Compliance of Modalities of Decisions of Limitations and Stops of Treatments
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Patient Hospitalized in Disease Infectious Unit
Patient Hospitalized in Intensive Reanimation Unit
Patient Hopsitalized in Internal Medicine Unit
Keywords: COVID 19
Limitations and stops of processing Active Therapeutic
ethics
Sanitary Crisis
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2020-06-30
Enrollment: 2500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient hospitalized in disease infectious Unit, or Patient hospitalized in intensive reanimation Unit, or Patient hopsitalized in Internal medicine Unit.

Brief summary: 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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Hospitalized major patient
* Infected or not with Covid-19
* having a management with a LAT defined by an anticipated or factual restriction of a therapeutic resource ( organ replacement, specific treatment) while his or her state of health requires or may require it, leading or not a death. The patient's death occurs either after a cariac massagewhich corresponds to a maximum management with therapeutic failure or within the framework or in the context of brain death, in these cases there is no LAT ; either without cardiac massage and in this case there is de facto a LAT wether or not it is performed according to legisltaive procedures. All patients who die will beclassified according to this diagram for the inclusion criterion. For surviving patients, an analysis of the record in search of LAT elments will be performed. In the absence of LAT elment in the record, i twill be considered that the patient did not have LAT and therfore will not be included.

Exclusion Criteria:

None

Primary outcomes:
measure: decisions of limitations and therapeutic stops
timeFrame: at the end of patient's hospitalization, an average of one month
Secondary outcomes:
measure: Characteristics of the notification of LAT procedure
timeFrame: at the end of patient's hospitalization, an average of one month
measure: Characteristics of the LAT procedure (persons who participated to the collegial discussion)
timeFrame: at the end of patient's hospitalization, an average of one month
measure: Characteristics of consultant's reasoned opinion for the LAT procedure
timeFrame: at the end of patient's hospitalization, an average of one month
measure: Characteristics of the LAT procedure
timeFrame: at the end of patient's hospitalization, an average of one month
measure: Characteristics of units
timeFrame: day 0
measure: Age of physicians
timeFrame: Day 0
measure: gendrer of physicians
timeFrame: Day 0
measure: Exparience of physicians
timeFrame: Day 0
measure: Characteristics of physicians
timeFrame: Day 0
measure: Age of patients
timeFrame: day 0
measure: patient's history
timeFrame: day 0
measure: COVID-19 patient's status
timeFrame: day 0
measure: Characteristics of hospitalization's patients
timeFrame: day 0
measure: Characteristics of affected organ
timeFrame: day 0
measure: Characteristics of patients
timeFrame: day 0
measure: final patient status
timeFrame: day 0
measure: patient's environnement
timeFrame: day 0
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
city: Lyon
country: France
facility: Hospices Civiles de Lyon
city: Vichy
country: France
facility: CH de Vichy
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Virginie Guastella
role: PRINCIPAL_INVESTIGATOR
References: