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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)

NCT ID: NCT04452487

Last Updated: 2020-06-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

2500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-01

Study Completion Date

2021-06-30

Brief Summary

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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

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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.

Conditions

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

Keywords

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COVID 19 Limitations and stops of processing Active Therapeutic ethics Sanitary Crisis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Patient 2019

Patients hospitalized in selected centers during march and june 2019

decisions of limitations and stop processing

Intervention Type BEHAVIORAL

Compliance of the modalities of decisions of limitations and stop processing

Patient 2020

Patients hospitalized in selected centers during march and june 2020 (during COVID-19 pandemia)

decisions of limitations and stop processing

Intervention Type BEHAVIORAL

Compliance of the modalities of decisions of limitations and stop processing

Patient 2021

Patients hospitalized in selected centers during march and june 2021

decisions of limitations and stop processing

Intervention Type BEHAVIORAL

Compliance of the modalities of decisions of limitations and stop processing

Interventions

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decisions of limitations and stop processing

Compliance of the modalities of decisions of limitations and stop processing

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Clermont-Ferrand

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Virginie Guastella

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

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CHU de Clermont-Ferrand

Clermont-Ferrand, , France

Site Status RECRUITING

Hospices Civiles de Lyon

Lyon, , France

Site Status NOT_YET_RECRUITING

CH de Vichy

Vichy, , France

Site Status NOT_YET_RECRUITING

Countries

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France

Central Contacts

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Lise LACLAUTRE

Role: CONTACT

Phone: +33473754963

Email: [email protected]

Facility Contacts

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Lise Laclautre

Role: primary

Jean-Christophe Richard

Role: primary

References

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Guastella V, Lambert C, Lafforgue A, Metretin P, Verstreate A, Watelet S, Perceau-Chambard E, Lautrette A. Withholding or withdrawing life-sustaining treatments in the COVID-19 pandemic: adherence to legal standards. BMJ Support Palliat Care. 2023 Aug 3:spcare-2023-004504. doi: 10.1136/spcare-2023-004504. Online ahead of print.

Reference Type DERIVED
PMID: 37536752 (View on PubMed)

Other Identifiers

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2020_GUASTELLA_COVID-19-LAT

Identifier Type: -

Identifier Source: org_study_id