Palliative CareWithdrawal of Life SupportIntensive Care MedicineSedationDying Process
Investigational drug(s) / intervention(s)
Protocol for palliative care and life-support withdrawal
Protocol for palliative care and life-support withdrawal: In the intervention group, end-of-life care will be provided in accordance with the study protocol, which specifies pharmacological management, nursing care, management of life-sustaining organ support, procedures for the assessment of comfort and pain, and support for relatives. Medical and nursing staff in intervention centers will receive on-site, face-to-face training on the care protocol within each ICU. An instructional video detailing the protocol will also be available.
Study summary
The ARREVE-3 trial will evaluate whether a structured palliative care protocol can improve end-of-life management for mechanically ventilated ICU patients in whom a decision to withdraw life-sustaining therapies has been made. This cluster-randomized controlled trial compares protocol-based care with usual practice across participating centers. The intervention includes comprehensive guidance on symptom management, sedation, nursing care, withdrawal procedures, and family support, supported by standardized staff training. The primary endpoint is adherence to recommended end-of-life practices, while secondary outcomes assess patient comfort, communication with relatives, and the impact on families and healthcare professionals
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Patient:
* Age ≥ 18 years
* ICU admission for more than 48 hours
* Receiving invasive mechanical ventilation
* A documented decision to withdraw life-sustaining therapies, made through a multidisciplinary collegial process and communicated to the designated surrogate decision-maker, family, or relatives
* At least one visit from a relative prior to the decision to withdraw life-sustaining therapies
* Provision of informed consent for study participation, or, if the patient lacks decision-making capacity, consent obtained from a relative or legally authorized representative
* Relative:
* Age ≥ 18 years
* Has received at least one medical update regarding the patient's clinical status from an ICU physician prior to the decision to withdraw life-sustaining therapies
* Has provided informed consent for study participation
Exclusion Criteria:
* Patient:
* Presence of a tracheostomy
* Brain death or involvement in an organ donation procedure
* Absence of any visit from a relative
* Subject to legal guardianship or other legal protection measures
* Incarcerated patient
* Participation in another interventional research study focused on end-of-life care
* Pregnant or breastfeeding woman
* Relative:
* Inability to understand or speak French
* Subject to legal guardianship or other legal protection measures
Primary outcome measure(s)
To assess whether, compared with usual care, the implementation of a palliative care protocol for mechanically ventilated patients-combined with dedicated staff training-improves adherence to guidelines. — From 1h before the date of life-support withdrawal to date of ICU discharge or death, whichever came first, assessed up to 28 days Proportion of patients receiving adequate sedation (RASS-5 within one hour before withdrawal of life-sustaining therapies) and withdrawal of mechanical ventilation
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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