NCT07368010

Brief 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

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
720

participants targeted

Target at P75+ for not_applicable

Timeline
33mo left

Started Jan 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress11%
Jan 2026Jan 2029

First Submitted

Initial submission to the registry

December 19, 2025

Completed
22 days until next milestone

Study Start

First participant enrolled

January 10, 2026

Completed
16 days until next milestone

First Posted

Study publicly available on registry

January 26, 2026

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2028

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2029

Last Updated

January 26, 2026

Status Verified

January 1, 2026

Enrollment Period

2 years

First QC Date

December 19, 2025

Last Update Submit

January 20, 2026

Conditions

Palliative CareWithdrawal of Life SupportIntensive Care MedicineSedationDying Process

Keywords

End of lifeintensive care medicinemechanical ventilationorgan supportwithdrawallife supportsedationpalliative care

Outcome Measures

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

    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 (31)

  • Evaluation of Sedation

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

  • Evaluation of Sedation

    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 Medications Other Than Sedatives

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

  • Administration of neuromuscular blocking agents

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

  • Administration of scopolamine

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

  • +26 more secondary outcomes

Study Arms (2)

Palliative care protocol

EXPERIMENTAL

Protocol for life-support withdrawal and palliative care during the withdrawal process

Other: Protocol for palliative care and life-support withdrawal

Usual Care

NO INTERVENTION

Withdrawal of life support at the end of life will be performed according to the usual practices of the participating ICUs

Interventions

Protocol for palliative care and life-support withdrawalOTHER

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.

Palliative care protocol

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Nantes

Nantes, 44, France

Location

MeSH Terms

Conditions

Death

Interventions

Clinical ProtocolsPalliative Care

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

TherapeuticsEpidemiologic Study CharacteristicsHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPatient CareHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Amélie SEGUIN, MD

    Nantes University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Amélie SEGUIN, MD

CONTACT

02 53 48 22 40amelie.seguin@chu-nantes.fr

Jean REIGNIER, MD Professor

CONTACT

jean.reignier@chu-nantes.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Cluster randomized controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2025

First Posted

January 26, 2026

Study Start

January 10, 2026

Primary Completion (Estimated)

January 10, 2028

Study Completion (Estimated)

January 10, 2029

Last Updated

January 26, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL
Time Frame
2027
Access Criteria
Open access

Locations

FR(1)