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Study of the Consequences of Infection on Compliance of Modalities of Decisions of Limitations and Stops of Treatments (COVID-19-LAT)

U

University Hospital, Clermont-Ferrand

Status

Unknown

Conditions

Patient Hopsitalized in Internal Medicine Unit
Patient Hospitalized in Intensive Reanimation Unit
Patient Hospitalized in Disease Infectious Unit

Treatments

Behavioral: decisions of limitations and stop processing

Study type

Observational

Funder types

Other

Identifiers

NCT04452487
2020_GUASTELLA_COVID-19-LAT

Details and patient eligibility

About

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

Full 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.

Enrollment

2,500 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

2,500 participants in 3 patient groups

Patient 2019
Description:
Patients hospitalized in selected centers during march and june 2019
Treatment:
Behavioral: decisions of limitations and stop processing
Patient 2020
Description:
Patients hospitalized in selected centers during march and june 2020 (during COVID-19 pandemia)
Treatment:
Behavioral: decisions of limitations and stop processing
Patient 2021
Description:
Patients hospitalized in selected centers during march and june 2021
Treatment:
Behavioral: decisions of limitations and stop processing

Trial contacts and locations

3

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Central trial contact

Lise LACLAUTRE

Data sourced from clinicaltrials.gov

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