跳至主要内容
临床试验/NCT05465187
NCT05465187已完成不适用

Withholding or Withdrawing of Life-sustaining Therapy in Great East French Region Intensive Care Units: a 1-month Survey

CHU de Reims1 个研究点 分布在 1 个国家目标入组 78 人开始时间: 2023年4月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
CHU de Reims
入组人数
78
试验地点
1
主要终点
Incidence of withholding or withdrawing of life-sustaining therapy

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Incidence of withholding or withdrawing of life-sustaining therapy

时间窗: 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.

次要结局

  • Conditions of setting up withholding or withdrawing of life-sustaining therapy(during the month of study)
  • Questionnaire Family Satisfaction with ICU - 24Revisited(during the month of study)
  • Agreement of these decisions with currently French legislation (" Claeys-Leonetti " lay, 2016)(at the inclusion of the patients in the study)

研究者

发起方
CHU de Reims
申办方类型
Other
责任方
Sponsor

研究点 (1)

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