Clinical trial NCT05465187: Withholding or Withdrawing of Life-sustaining Therapy in Great East French Region Intensive Care Units: a 1-month Survey
Official title: Withholding or Withdrawing of Life-sustaining Therapy in Great East French Region Intensive Care Units: a 1-month Survey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intensive Care Units
Family's Satisfaction
Therapy Decisions
Keywords: Intensive care
family's feelings
Lead sponsor: CHU de Reims
Sponsor class: OTHER
First posted: 2022-07-19
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: Inclusion criteria :

* 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.

Exclusion criteria :

* 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

Primary outcomes:
measure: Incidence of withholding or withdrawing of life-sustaining therapy
timeFrame: Day 28
Secondary outcomes:
measure: Conditions of setting up withholding or withdrawing of life-sustaining therapy
timeFrame: during the month of study
measure: Agreement of these decisions with currently French legislation (" Claeys-Leonetti " lay, 2016)
timeFrame: at the inclusion of the patients in the study
measure: Questionnaire Family Satisfaction with ICU - 24Revisited
timeFrame: during the month of study
Other outcomes:
Locations:
city: Reims
country: France
facility: Damien JOLLY
Study officials:
References: