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.
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
- Are there results?
- None posted in the registry
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.
France3 sites, 3 recruiting
- Recruiting
CHU de Clermont-Ferrand
Clermont-Ferrand, 63000
Lise Laclautre, +33473754963, promo_interne_drci@chu-clermontferrand.fr
Viginie Guastella
- Not yet 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
About this study
Official title: Study of the Consequences of Infection on Compliance of Modalities of Decisions of Limitations and Stops of Treatments
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 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 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.
- 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.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- 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)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Virginie Guastella, Principal investigator, University Hospital, Clermont-Ferrand
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
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Consequences of Infection on Compliance of Modalities of Decisions of Limitations and Stops of Treatments
- ClinicalTrials.gov ID
- NCT04452487
- Acronym / sponsor ID
- COVID-19-LAT / 2020_GUASTELLA_COVID-19-LAT
- 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
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 30 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patient 2019 | – | Behavioral: decisions of limitations and stop processingPatients hospitalized in selected centers during march and june 2019 |
| Patient 2020 | – | Behavioral: decisions of limitations and stop processingPatients hospitalized in selected centers during march and june 2020 (during COVID-19 pandemia) |
| Patient 2021 | – | Behavioral: decisions of limitations and stop processingPatients hospitalized in selected centers during march and june 2021 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| decisions of limitations and stop processingCompliance of the modalities of decisions of limitations and stop processing | Behavioural | Patient 2019, Patient 2020, Patient 2021 |
Primary outcome
decisions of limitations and therapeutic stops
Time frame: at the end of patient's hospitalization, an average of one month
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
17 secondary outcomes
Characteristics of the notification of LAT procedure
Time frame: at the end of patient's hospitalization, an average of one month
Characteristics of the LAT procedure (persons who participated to the collegial discussion)
Time frame: at the end of patient's hospitalization, an average of one month
Characteristics of consultant's reasoned opinion for the LAT procedure
Time frame: at the end of patient's hospitalization, an average of one month
Characteristics of the LAT procedure
Time frame: at the end of patient's hospitalization, an average of one month
Characteristics of units
Time frame: day 0
Age of physicians
Time frame: Day 0
gendrer of physicians
Time frame: Day 0
Exparience of physicians
Time frame: Day 0
Characteristics of physicians
Time frame: Day 0
Age of patients
Time frame: day 0
patient's history
Time frame: day 0
COVID-19 patient's status
Time frame: day 0
Characteristics of hospitalization's patients
Time frame: day 0
Characteristics of affected organ
Time frame: day 0
Characteristics of patients
Time frame: day 0
final patient status
Time frame: day 0
patient's environnement
Time frame: day 0
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2020.
- Derived from this study: PubMed 37536752Guastella 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Virginie Guastella principal investigator
University Hospital, Clermont-Ferrand
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lise LACLAUTRE (+33473754963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
decisions of limitations and therapeutic stops (time frame: at the end of patient's hospitalization, an average of one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04452487, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2020.