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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Intensive Care Units; Family's Satisfaction; Therapy Decisions
• Intervention / Treatment: Other: Non applicable

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 Type: Observational
• Enrollment (Anticipated): 250

Contacts and Locations

• Study Contact: Name: Vincent LEGROS; Phone Number: 0033 03 26 78 30 21; Email: vlegros@chu-reims.fr

Study Locations

• France
  • Reims, France
    • Damien JOLLY
    • Contact: Vincent LEGROS; Phone Number: 0033 03 26 78 30 21; Email: vlegros@chu-reims.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: Non applicable; Non applicable

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Day 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	during the month of study

Collaborators and Investigators

• Sponsor: CHU de Reims

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2022
• Primary Completion (Anticipated): October 1, 2022
• Study Completion (Anticipated): November 1, 2022

Study Registration Dates

• First Submitted: July 18, 2022
• First Submitted That Met QC Criteria: July 18, 2022
• First Posted (Actual): July 19, 2022

Study Record Updates

• Last Update Posted (Actual): July 19, 2022
• Last Update Submitted That Met QC Criteria: July 18, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Intensive care; family's feelings
• Other Study ID Numbers: PO22080

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No