Patient Hospitalized in Disease Infectious UnitCOVID-19-LATNCT04452487

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

An observational study of Patient Hospitalized in Disease Infectious Unit and Patient Hospitalized in Intensive Reanimation Unit, run by University Hospital, Clermont-Ferrand at 3 sites in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial 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 Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Patient Hospitalized in Disease Infectious Unit, Patient Hospitalized in Intensive Reanimation Unit, Patient Hopsitalized in Internal Medicine Unit
What is being tested?: decisions of limitations and stop processing
Type of treatment: Lifestyle or therapy programme
How many people: 2,500 participants
Where: 3 sitesFrance
Study dates: 1 Jun 2020to Jun 2021
Phase: Observational

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Patient hospitalized in disease infectious Unit, or Patient hospitalized in intensive reanimation Unit, or Patient hopsitalized in Internal medicine Unit.

Who may be able to join

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.

Who cannot join

None

Trial locations and contacts

3 sites in 1 country.

Lise LACLAUTRE contact

+33473754963

promo_interne_drci@chu-clermontferrand.fr

France3 sites, 3 recruiting

CHU de Clermont-Ferrand
Clermont-Ferrand, 63000
Lise Laclautre, +33473754963, promo_interne_drci@chu-clermontferrand.fr
Viginie Guastella
Recruiting
Hospices Civiles de Lyon
Lyon, 69000
Jean-Christophe Richard, j-christophe.richard@chu-lyon.fr
Jean-Christophe RICHARD
Not yet recruiting
CH de Vichy
Vichy, 03000
Not yet recruiting

Other trials in France

About this study

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

Read the 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.

Conditions: Patient Hospitalized in Disease Infectious Unit, Patient Hospitalized in Intensive Reanimation Unit, Patient Hopsitalized in Internal Medicine Unit
Being tested: decisions of limitations and stop processing
Keywords: COVID 19, Limitations and stops of processing Active Therapeutic, ethics, Sanitary Crisis
Medical subject headings: COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

decisions of limitations and stop processingBehavioural
Compliance of the modalities of decisions of limitations and stop processing

Study groups in NCT04452487
Study group	Role	What they receive
Patient 2019		Patients hospitalized in selected centers during march and june 2019 Receives: Behavioral: decisions of limitations and stop processing
Patient 2020		Patients hospitalized in selected centers during march and june 2020 (during COVID-19 pandemia) Receives: Behavioral: decisions of limitations and stop processing
Patient 2021		Patients hospitalized in selected centers during march and june 2021 Receives: Behavioral: decisions of limitations and stop processing

What is being measured

The primary outcome is the main question the study is designed to answer.

decisions of limitations and therapeutic stops
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
Measured: at the end of patient's hospitalization, an average of one month

Secondary outcomes (17)

Characteristics of the notification of LAT procedure
notification of the decision, the conclusions of the discussions, the opinion of the consultant and the arguments given to justify the LAT
Measured: at the end of patient's hospitalization, an average of one month
Characteristics of the LAT procedure (persons who participated to the collegial discussion)
number and status of caregivers who participated to the collegial discussion
Measured: at the end of patient's hospitalization, an average of one month
Characteristics of consultant's reasoned opinion for the LAT procedure
formal elements of the consultant's reasoned opinion ( legal term) in the file
Measured: at the end of patient's hospitalization, an average of one month
Characteristics of the LAT procedure
formal elements of advance directives
Measured: at the end of patient's hospitalization, an average of one month
Characteristics of units
number of beds, number of caregivers (medical, paramedical, internal external), number of admissions during periods of study
Measured: day 0
Age of physicians
measured in year
Measured: Day 0
gendrer of physicians
male or female
Measured: Day 0
Exparience of physicians
Measured in year of experience
Measured: Day 0
Characteristics of physicians
professional status
Measured: Day 0
Age of patients
measured in year
Measured: day 0
patient's history
comorbidities
Measured: day 0
COVID-19 patient's status
COVID19 infection (yes or no)
Measured: day 0
Characteristics of hospitalization's patients
hospitalization reason
Measured: day 0
Characteristics of affected organ
organ failure
Measured: day 0
Characteristics of patients
severity score
Measured: day 0
final patient status
fate
Measured: day 0
patient's environnement
family presence or relatives
Measured: day 0

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jun 2020Jun 2021

First posted30 Jun 2020
Study start1 Jun 2020
Primary completionJun 2021 (estimated)
Study completionJun 2021 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Patient Hospitalized in Disease Infectious UnitStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case-control
Time perspective: Prospective
Enrolment: 2,500 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04452487
Sponsor's protocol ID: 2020_GUASTELLA_COVID-19-LAT
Acronym: COVID-19-LAT
Status last verified: Jun 2020
First submitted: 23 Jun 2020
Last updated: 30 Jun 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

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.
PubMed 37536752