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(DIS)AGreement of Relatives Regarding Ethical End-of-life Decisions in ICU. ((DIS)AGREE)

S

Société Française d'Anesthésie et de Réanimation

Status

Completed

Conditions

Cessation of Treatment
End of Life

Treatments

Other: observational

Study type

Observational

Funder types

Other

Identifiers

NCT05768906
(DIS)AGREE - 2022-02

Details and patient eligibility

About

In the ICU, the vast majority of patients die following a life-sustaining therapies (LST) limitation decision. Most often, the patient is not able to express himself and has not made his wishes known beforehand, for example in the form of advance directives. The "relatives" are then the only recourse to state the patient's wishes, without any guarantee that they are aware of them. In France, the final decision is made by the physician (or the medical team) who is responsible for it. In this context, disagreements and even real legal conflicts on LST limitation decisions between relatives and physicians seem to be more and more frequent. To our knowledge, few data exist on the frequency of these disagreements over LST limitation decisions.

The main objective of this study is to evaluate the frequency of disagreements between relatives and physicians over LST limitation decisions in adult intensive care.

Full description

Context In the ICU, the vast majority of patients die following a life-sustaining therapies (LST) limitation decision. Most often, the patient is not able to express himself and has not made his wishes known beforehand, for example in the form of advance directives. The "relatives" are then the only recourse to state the patient's wishes, without any guarantee that they are aware of them. In France, the final decision is made by the physician (or the medical team) who is responsible for it. In this context, disagreements and even real legal conflicts on LST limitation decisions between relatives and physicians seem to be more and more frequent. To our knowledge, few data exist on the frequency of these disagreements over LST limitation decisions.

Purpose The main objective of this study is to evaluate the frequency of disagreements between relatives and physicians over LST limitation decisions in adult intensive care.

The secondary objectives are:

  • To assess the level of agreement/disagreement between family members and physicians regarding LST limitation decisions
  • To assess the proportion of disagreements experienced as conflictual
  • To assess the impact of the disagreement on the LST limitation decision (implementation of the decision, time between the decision and its implementation, length of hospitalization...)
  • To describe possible factors that contribute to disagreement and conflict
  • To describe national LST limitation decision-making practices.

Enrollment

429 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Consecutive inclusion of all situations in which a life-sustaining therapies limitation decision was made
  • Patients hospitalized in a French intensive care unit
  • Age of the patient ≥ 18 years
  • If relatives are present, age of at least one of the relatives ≥ 18 years NB: situations of "non-re-admission" decisions in intensive care are not taken into account in the inclusion criteria.

Exclusion criteria

  • Minor patient
  • Patient under guardianship
  • Conscious patient, able to express himself/herself and able to decide jointly with the medical team
  • Patient for whom a life-sustaining therapies limitation decision was already made prior to ICU admission.

Trial design

429 participants in 1 patient group

Life-sustaining therapies limitation decision situations - observation only
Description:
For each participating center, consecutive inclusion of the first 10 life-sustaining therapies limitation decision situations from the study start date over a maximum of 12 months. Data collection for these patients especialy information concerning disagreements and even real legal conflicts on life-sustaining therapies limitation decisions between relatives and physicians.
Treatment:
Other: observational

Trial contacts and locations

23

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Central trial contact

Chafia Daoui; Mikhael Giabicani, MD

Data sourced from clinicaltrials.gov

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