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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)

Study of the Consequences of Infection on Compliance of Modalities of Decisions of Limitations and Stops of Treatments

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04452487
Acronym
COVID-19-LAT
Enrollment
2500
Registered
2020-06-30
Start date
2020-06-01
Completion date
2021-06-30
Last updated
2020-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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.

Interventions

BEHAVIORALdecisions of limitations and stop processing

Compliance of the modalities of decisions of limitations and stop processing

Sponsors

University Hospital, Clermont-Ferrand
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
decisions of limitations and therapeutic stopsat the end of patient's hospitalization, an average of one monthThe 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

Secondary

MeasureTime frameDescription
Characteristics of the LAT procedure (persons who participated to the collegial discussion)at the end of patient's hospitalization, an average of one monthnumber and status of caregivers who participated to the collegial discussion
Characteristics of consultant's reasoned opinion for the LAT procedureat the end of patient's hospitalization, an average of one monthformal elements of the consultant's reasoned opinion ( legal term) in the file
Characteristics of the LAT procedureat the end of patient's hospitalization, an average of one monthformal elements of advance directives
Characteristics of unitsday 0number of beds, number of caregivers (medical, paramedical, internal external), number of admissions during periods of study
Age of physiciansDay 0measured in year
gendrer of physiciansDay 0male or female
Exparience of physiciansDay 0Measured in year of experience
Characteristics of physiciansDay 0professional status
Characteristics of the notification of LAT procedureat the end of patient's hospitalization, an average of one monthnotification of the decision, the conclusions of the discussions, the opinion of the consultant and the arguments given to justify the LAT
patient's historyday 0comorbidities
COVID-19 patient's statusday 0COVID19 infection (yes or no)
Characteristics of hospitalization's patientsday 0hospitalization reason
Characteristics of affected organday 0organ failure
Characteristics of patientsday 0severity score
final patient statusday 0fate
patient's environnementday 0family presence or relatives
Age of patientsday 0measured in year

Countries

France

Contacts

Primary ContactLise LACLAUTRE
promo_interne_drci@chu-clermontferrand.fr+33473754963

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026