Intensive Care UnitsLATANCT05465187
Withholding or Withdrawing of Life-sustaining Therapy in Great East French Region Intensive Care Units: a 1-month Survey
An observational study of Intensive Care Units and Family's Satisfaction, run by CHU de Reims at 1 site in France.
Trial summary
Intensive care has known an important scientists progress for the last twenty years, allowing to heal more and more severe patients. Throughout the time, population has been getting old more and more, making patients affected by several diseases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intensive Care Units, Family's Satisfaction, Therapy Decisions
- What is being tested?
- Non applicable
- How many people
- 78 participants
- Where
- 1 siteFrance
- Study dates
- 3 Apr 2023to 2 Nov 2023
- 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: Adults patients aged for more than 18 years old hospitalized in an intensive care unit in Grand-Est region in France during the month of study, for whom a decision of withholding or withdrawing of life-sustaining therapy is taken during the month of study. Contentment of the patient or their confident person must be collected to allow inclusion.
Who may be able to join
- Adults patients hospitalized in an intensive care unit in Grand-Est region in France
- For whom a decision of withholding or withdrawing of life-sustaining therapy is taken during the month of study
- Contentment of the patient or their support person collected.
Who cannot join
- Patients aged less than 18 years old
- Who already have a decision of withholding or withdrawing of life-sustaining therapy taken before the beginning of the study
Trial locations and contacts
1 site in 1 country.
About this study
Intensive care has known an important scientists progress for the last twenty years, allowing to heal more and more severe patients. Throughout the time, population has been getting old more and more, making patients affected by several diseases.
As any medical specialty, intensive care has been confronted to these both evolutions. Thus ethical issues subsist for many years concerning rationality of cares intensity given to the patients.
Read more
Withholding or withdrawing of life-sustaining therapy represents a non-negligible part of deaths in intensive care units in France. Throughout the years, it has been more and more leading French laws, as the Clayes-Leonetti law, one of the most important and recent one, which has governed ending life patients' rights since 2016.
Thus it appears interesting to propose this study to evaluate proportion of withholding or withdrawing of life-sustaining therapy and their conditions of setting up in a maximum of intensive care units in the Grand-Est region in France in 2022 ; and to collect family's feelings concerning these decisions.
Read the detailed description
Intensive care has known an important scientists progress for the last twenty years, allowing healing more and more severe patients. Throughout the time, population has been getting old more and more, making patients affected by several comorbidities.
As any medical specialty, intensive care has been confronted to these both evolutions. Thus ethical issues subsist for many years concerning rationality of cares intensity given to the patients. Depending on their age, and their comorbidities. Indeed, if cares are still possibles, disponibles and dispensables, they are not necessarily faithful.
Withholding or withdrawing of life-sustaining therapy represents a non-negligible part of deaths in intensive care units in France. In the literature, these decisions concern 8,5% to 14% of patients residents in an intensive care unit in France, with variations depending on age, so can reach 20% on patients aged more than 80 years old.
Among recent studies concerning withholding or withdrawing of life-sustaining therapy in French intensive care units, LATAREA is one of the first biggest (148 intensive care units, 7488 patients). It gives us important information about the subject. However, this study is an old one (1997), previous to Clayes-Leonetti law promulgation, which has governed ending life patients' rights since 2016. In LATAREA study, 11% of patients had measures of withholding or withdrawing of life-sustaining therapy; and mortality in intensive care units among these patients was at 78%. WLST conditions were described briefly.
A study from EPILAT group, even if more recent (2015), gives us interesting data too, but it is an ancillary study with recruitment on only 616 intensive care beds, which represented 10% of intensive care beds at the time approximately. In this study, 14% of the patients were undergoing withholding or withdrawing of life-sustaining therapy. Among notable data, we can read that an external opinion was given in less than 50% of the cases, and that less than 2% of the patients had named somebody as one's support person or had written advanced directives. It also showed that WLST percentage crossed from 8% to 30% of admissions depending on intensive care units participating.
By the way, it appears interesting to propose this study to know incidence and conditions of setting up withholding or withdrawing of life-sustaining therapy in a maximum of intensive care units in the Grand-Est region in France in 2022 ; and to collect family's feelings concerning these decisions.
- Being tested
- Non applicable
- Keywords
- Intensive care, family's feelings
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non applicableOther
Non applicable
| Study group | Role | What they receive |
|---|---|---|
| Patients | Adults patients aged for more than 18 years old, admitted in an intensive care unit in Grand-Est region in France, for whom a decision of withholding or withdrawing of life-sustaining therapy is taken during the month of study. Receives: Other: Non applicable |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of withholding or withdrawing of life-sustaining therapy
The primary outcome measure will consist in determine the part of withholding or withdrawing of life-sustaining therapy measures in Grand Est French ICU to learn about their importance. Thus we can compare it to data we know from previous studies first. Second, we can evaluate the evolution throughout the time if there is one and the impact of new laws for example.
Measured: Day 28
Secondary outcomes (3)
Conditions of setting up withholding or withdrawing of life-sustaining therapy
Conditions can be studied by screening many data, including : data related to the intensive care unit ; data related to generalities about withholding or withdrawing of life-sustaining therapy in the center ; data related to description of population studied ; data related to the period of study ; data concerning the characteristics of the patient and measure of withholding/withdrawing of life-sustaining therapy. All data will be collected via two CRF we elaborated.
Measured: during the month of study
Agreement of these decisions with currently French legislation (" Claeys-Leonetti " lay, 2016)
This secondary outcome measures rest on checking if the application of the measure studied in the intensive care unit is in accordance with the official law. Abuse could occur and had to be known to avoid misunderstandings and downward spiral.
Measured: at the inclusion of the patients in the study
Questionnaire Family Satisfaction with ICU - 24Revisited
This a validated questionary to evaluate family's patient satisfaction concerning the hospitalization of their relative in the intensive care unit. More precisely, this is a global evaluation in terms of quality of cares dispensed. It is divided in two parts, included satisfaction regarding cares and satisfaction with the decision concerning patient cares in severe illness status. It ends with some demographic informations. Finally it aims is to improve fonctionnement of intensive care units.
Measured: during the month of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2022
- Study start3 Apr 2023
- Primary completion2 Nov 2023
- Study completion2 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensive Care UnitsStudies of the same condition, open and under way.
- More trials run by CHU de ReimsThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05465187
- Sponsor's protocol ID
- PO22080
- Acronym
- LATA
- Status last verified
- Feb 2025
- First submitted
- 18 Jul 2022
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Withholding or Withdrawing of Life-sustaining Therapy in Great East French Region Intensive Care Units: a 1-month Survey
- ClinicalTrials.gov ID
- NCT05465187
- Acronym / sponsor ID
- LATA / PO22080
- Keywords
- Intensive care, family's feelings
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- 3 Apr 2023 (actual)
- Primary completion
- 2 Nov 2023 (actual)
- Study completion
- 2 Nov 2023 (actual)
- First posted
- 19 Jul 2022 (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.
Intensive care has known an important scientists progress for the last twenty years, allowing to heal more and more severe patients. Throughout the time, population has been getting old more and more, making patients affected by several diseases.
As any medical specialty, intensive care has been confronted to these both evolutions. Thus ethical issues subsist for many years concerning rationality of cares intensity given to the patients.
Withholding or withdrawing of life-sustaining therapy represents a non-negligible part of deaths in intensive care units in France. Throughout the years, it has been more and more leading French laws, as the Clayes-Leonetti law, one of the most important and recent one, which has governed ending life patients' rights since 2016.
Thus it appears interesting to propose this study to evaluate proportion of withholding or withdrawing of life-sustaining therapy and their conditions of setting up in a maximum of intensive care units in the Grand-Est region in France in 2022 ; and to collect family's feelings concerning these decisions.
Detailed description
Intensive care has known an important scientists progress for the last twenty years, allowing healing more and more severe patients. Throughout the time, population has been getting old more and more, making patients affected by several comorbidities.
As any medical specialty, intensive care has been confronted to these both evolutions. Thus ethical issues subsist for many years concerning rationality of cares intensity given to the patients. Depending on their age, and their comorbidities. Indeed, if cares are still possibles, disponibles and dispensables, they are not necessarily faithful.
Withholding or withdrawing of life-sustaining therapy represents a non-negligible part of deaths in intensive care units in France. In the literature, these decisions concern 8,5% to 14% of patients residents in an intensive care unit in France, with variations depending on age, so can reach 20% on patients aged more than 80 years old.
Among recent studies concerning withholding or withdrawing of life-sustaining therapy in French intensive care units, LATAREA is one of the first biggest (148 intensive care units, 7488 patients). It gives us important information about the subject. However, this study is an old one (1997), previous to Clayes-Leonetti law promulgation, which has governed ending life patients' rights since 2016. In LATAREA study, 11% of patients had measures of withholding or withdrawing of life-sustaining therapy; and mortality in intensive care units among these patients was at 78%. WLST conditions were described briefly.
A study from EPILAT group, even if more recent (2015), gives us interesting data too, but it is an ancillary study with recruitment on only 616 intensive care beds, which represented 10% of intensive care beds at the time approximately. In this study, 14% of the patients were undergoing withholding or withdrawing of life-sustaining therapy. Among notable data, we can read that an external opinion was given in less than 50% of the cases, and that less than 2% of the patients had named somebody as one's support person or had written advanced directives. It also showed that WLST percentage crossed from 8% to 30% of admissions depending on intensive care units participating.
By the way, it appears interesting to propose this study to know incidence and conditions of setting up withholding or withdrawing of life-sustaining therapy in a maximum of intensive care units in the Grand-Est region in France in 2022 ; and to collect family's feelings concerning these decisions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: Non applicableAdults patients aged for more than 18 years old, admitted in an intensive care unit in Grand-Est region in France, for whom a decision of withholding or withdrawing of life-sustaining therapy is taken during the month of study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults patients aged for more than 18 years old hospitalized in an intensive care unit in Grand-Est region in France during the month of study, for whom a decision of withholding or withdrawing of life-sustaining therapy is taken during the month of study. Contentment of the patient or their confident person must be collected to allow inclusion.
Key inclusion criteria (3 listed)
- Adults patients hospitalized in an intensive care unit in Grand-Est region in France
- For whom a decision of withholding or withdrawing of life-sustaining therapy is taken during the month of study
- Contentment of the patient or their support person collected.
Key exclusion criteria (2 listed)
- Patients aged less than 18 years old
- Who already have a decision of withholding or withdrawing of life-sustaining therapy taken before the beginning of the study
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 |
|---|---|---|
| Non applicableNon applicable | Other | Patients |
Primary outcome
Incidence of withholding or withdrawing of life-sustaining therapy
Time frame: Day 28
The primary outcome measure will consist in determine the part of withholding or withdrawing of life-sustaining therapy measures in Grand Est French ICU to learn about their importance. Thus we can compare it to data we know from previous studies first. Second, we can evaluate the evolution throughout the time if there is one and the impact of new laws for example.
3 secondary outcomes
Conditions of setting up withholding or withdrawing of life-sustaining therapy
Time frame: during the month of study
Agreement of these decisions with currently French legislation (" Claeys-Leonetti " lay, 2016)
Time frame: at the inclusion of the patients in the study
Questionnaire Family Satisfaction with ICU - 24Revisited
Time frame: during the month of study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intensive Care Units and Family's Satisfaction, run by CHU de Reims at 1 site 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 2 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: finished, as of the sponsor's last update on 7 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of withholding or withdrawing of life-sustaining therapy (time frame: Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Feb 2025.