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

NCT05465187 | Completed

• 1 other identifier: PO22080
• Study Type: observational
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Intensive Care Units; Family's Satisfaction; Therapy Decisions

Keywords

Intensive care; family's feelings

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Conditions of setting up withholding or withdrawing of life-sustaining therapy

  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

• Questionnaire Family Satisfaction with ICU - 24Revisited

  during the month of study

Study Arms (1)

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

Interventions

Non applicable OTHER

Non applicable

Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• CHU de Reims: lead

Study Sites (1)

Damien JOLLY

Reims, France

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2022
• First Posted: July 19, 2022
• Study Start: April 3, 2023
• Primary Completion: November 2, 2023
• Study Completion: November 2, 2023
• Last Updated: February 7, 2025

Record last verified: 2025-02

Locations

FR (1)