Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT05465187 |
| Other study ID # |
PO22080 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 2022 |
| Est. completion date |
November 2022 |
Study information
| Verified date |
July 2022 |
| Source |
CHU de Reims |
| Contact |
Vincent LEGROS |
| Phone |
03 26 78 30 21 |
| Email |
vlegros[@]chu-reims.fr |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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.
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.
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.
