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End-of-life Care in Mechanically Ventilated Patients: Impact of a Comprehensive Palliative Care Protocol in the Intensive Care Setting

ConditionsPalliative CareWithdrawal of Life SupportIntensive Care MedicineSedationDying Process
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNantes University Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Protocol for palliative care and life-support withdrawal

    Other intervention

    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.

Treatment groups

720 Participants
are divided into 2 treatment groups
Group A: Palliative care protocolExperimental treatment 1 intervention
Group B: Usual CareNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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.

Proportion of patients receiving adequate sedation (RASS-5 within one hour before withdrawal of life-sustaining therapies) and withdrawal of mechanical ventilation

Time frame
From 1h before the date of life-support withdrawal to date of ICU discharge or death, whichever came first, assessed up to 28 days

Secondary outcomes

1

Evaluation of Sedation

Maximum rate of continuous infusion of each sedative agent administered (within 1 hour before the first withdrawal of life sustaining therapies and death)

Time frame
From 1h before the date of life-support withdrawal to date of ICU discharge or death, whichever came first, assessed up to 28 days
2

Evaluation of Sedation

Number of sedative boluses and number of dose escalations of continuous sedation between inclusion and death

Time frame
From 1h before the date of life-support withdrawal to date of ICU discharge or death, whichever came first, assessed up to 28 days
3

Proportion of Patients Receiving Medications Other Than Sedatives

Proportion of patients receiving neuromuscular blocking agents, scopolamine, paracetamol (acetaminophen), or antiemetic agents.

Time frame
From 1h before the date of life-support withdrawal to date of ICU discharge or death, whichever came first, assessed up to 28 days
4

Administration of neuromuscular blocking agents

Proportion of patients receiving neuromuscular blocking agents

Time frame
From 1h before the date of life-support withdrawal to date of ICU discharge or death, whichever came first, assessed up to 28 days

Other outcomes

Sponsors and contacts

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Nantes University Hospital

Lead sponsor

University of Burgundy

Collaborator

Centre Hospitalier Universitaire de Saint Louis APHP

Collaborator

University Hospital, Tours

Collaborator

Source ClinicalTrials.gov

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