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| Name | Class |
|---|---|
| University of Burgundy | OTHER |
| Centre Hospitalier Universitaire de Saint Louis APHP | UNKNOWN |
| University Hospital, Tours | OTHER |
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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
Among ICU patients who die after a decision to withdraw life-sustaining therapies, most are receiving mechanical ventilation (MV). Withdrawal of MV may cause discomfort, and end-of-life practices can have a lasting impact on both families and healthcare professionals. Despite international guidelines and recent legislative changes in France, end-of-life practices in the ICU remain highly variable, indicating substantial opportunities for improvement in patient comfort-focused management.
The ARREVE-3 trial aimes to determine whether a structured palliative care protocol for mechanically ventilated patients undergoing withdrawal of life-sustaining therapies improves the quality of the dying process. Developed in collaboration with palliative care specialists, a psychologist, and a sociologist, the protocol provides standardized guidance on pharmacological and non-pharmacological interventions, including symptom assessment tools, sedation strategies, nursing care, and procedures for withdrawal of life-sustaining treatment. Structured recommendations for support of relatives are also included.
ARREVE-3 is a pragmatic, interventional, cluster-randomized controlled trial, with participating ICUs being unit of randomization to minimize contamination between study arms. ICUs randomized to the intervention arm will apply the palliative care protocol, whereas control ICUs will continue to follow usual care. Physicians and nurses in intervention ICUs will receive standardized training from the coordinating team, complemented by a video-based educational module. Designated local champions within each ICU will support implementation and adherence.to the protocol.
The primary endpoint is adherence to the protocol for end-of-life care. Secondary outcomes include patient comfort, quality of communication with relatives, and the impact of the end-of-life process on relatives and healthcare professionals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Palliative care protocol | Experimental | Protocol for life-support withdrawal and palliative care during the withdrawal process |
|
| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Protocol for palliative care and life-support withdrawal | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | From 1h before the date of life-support withdrawal to date of ICU discharge or death, whichever came first, assessed up to 28 days |
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Inclusion Criteria:
Patient:
Relative:
Exclusion Criteria:
Patient:
Relative:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amélie SEGUIN, MD | Contact | 02 53 48 22 40 | +332 | amelie.seguin@chu-nantes.fr |
| Jean REIGNIER, MD Professor | Contact | jean.reignier@chu-nantes.fr |
| Name | Affiliation | Role |
|---|---|---|
| Amélie SEGUIN, MD | Nantes University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Nantes | Nantes | 44 | France |
|
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2027
Open access
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Cluster randomized controlled trial
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|
| Evaluation of Sedation |
Number of sedative boluses and number of dose escalations of continuous sedation between inclusion and death |
| 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 | Proportion of patients receiving neuromuscular blocking agents, scopolamine, paracetamol (acetaminophen), or antiemetic 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 neuromuscular blocking agents | Proportion of patients receiving 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 | Proportion of patients receiving 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 |
| Administration of paracetamol (acetaminophen) | Proportion of patients receiving paracetamol (acetaminophen) | 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 Receiving antiemetic agents | Proportion of patients receiving antiemetic 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 |
| The Semi-Lateral (¾ Lateral) Position | Proportion of patients positioned in the semi-lateral (¾ lateral) position 1 hour before treatment withdrawal and 1 hour before death | From 1h before the date of life-support withdrawal to date of ICU discharge or death, whichever came first, assessed up to 28 days |
| Life-Sustaining Organ Support Management | Proportion of patients receiving dialysis, vasoactive drug and/or ECMO at inclusion and at death | From inclusion to date of ICU discharge or death, whichever came first, assessed up to 28 days |
| Life-Sustaining Organ Support Management | Proportion of patients in whom all life-sustaining therapies are discontinued before death | From inclusion to death, assessed up to 28 days |
| Life-Sustaining Organ Support Management | Proportion of patients in whom all life-sustaining therapies are withdrawn concomitantly | From inclusion to date of ICU discharge or death, whichever came first, assessed up to 28 days |
| Life-Sustaining Organ Support Management | Proportion of patients whith immediate extubation | From inclusion to date of ICU discharge or death, whichever came first, assessed up to 28 days |
| Time from Inclusion to Extubation | Time interval between inclusion and extubation | From inclusion to date of extubation, assessed up to 28 days |
| Assessment of Sedation | Proportion of patients with a Richmond Agitation-Sedation Scale (RASS) score of -5 or > -4 (≥ -3) 1 hour before withdrawal of the first life-sustaining therapy (mechanical ventilation, vasopressors, or ECMO) and 1 hour before extubation | From inclusion to date of ICU discharge or death, whichever came first, assessed up to 28 days |
| Assessment of Pain Management | Higher Behavioral Pain Scale (BPS) score 1 hour before withdrawal of the first life-sustaining therapy (mechanical ventilation, vasopressors, or ECMO); BPS min = 3, max = 12; Higher scores correlate with increased pain intensity. | From 1h before the date of life-support withdrawal to date of ICU discharge or death, whichever came first, assessed up to 28 days |
| Assessment of Comfort Management | Proportion of patients with airway secretion scores of 3 or 4 | From 1h before the date of life-support withdrawal to date of ICU discharge or death, whichever came first, assessed up to 28 days |
| Assessment of Comfort Management | Proportion of patients with more than one gasp (≥ 2) | From 1h before the date of life-support withdrawal to date of ICU discharge or death, whichever came first, assessed up to 28 days |
| Assessment of Communication with Relatives | Proportion of relatives who had at least three meetings with ICU caregivers | From inclusion to date of ICU discharge, assessed up to 28 days |
| Assessment of Communication with Relatives | Proportion of meetings conducted jointly by a senior physician and a nurse | From inclusion to date of ICU discharge, assessed up to 28 days |
| Assessment of Communication with Relatives | Proportion of relatives who had a meeting with a psychologist | From inclusion to date of ICU discharge, assessed up to 28 days |
| Assessment of Conflicts | Level of conflicts between ICU healthcare givers and relatives, as rated on a 0-10 Likert scale. A higher score indicates a more intense conflict. | From inclusion to date of ICU discharge, assessed up to 28 days |
| Assessment of Conflicts | Level of conflicts between among healthcare professionals, as rated on a 0-10 Likert scale. A higher score indicates a more intense conflict. | From inclusion to date of ICU discharge, assessed up to 28 days |
| Assessment of Conflicts | Level of conflicts between among relatives, as rated on a 0-10 Likert scale. A higher score indicates a more intense conflict. | From inclusion to date of ICU discharge, assessed up to 28 days |
| Assessment of Quality of Dying by Relatives | Quality of Dying and Death questionnaire (QODD-1) assessed 1 month after death, as rated on a 0-10 Likert scale. Higher scores correlate with a more satisfactory level of care. | From inclusion to 1 month after death of the patient |
| Anxiety and Depression in Relatives | Hospital Anxiety and Depression Scale (HADS) assessed 1, 3, 6, and 12 months after death. HADS min = 0, max = 42; Higher scores correlate with increased risk of anxiety and depression. | From inclusion to 1, 3, 6, and 12 months after the death of the patient |
| Post-Traumatic Stress Disorders in Relatives | Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5) assessed 1, 3, 6, and 12 months after death. PCL-5 min = 0, max = 80; Higher scores correlate with increased risk of posttraumatic stress. | From inclusion to 1, 3, 6, and 12 months after the death of the patient |
| Prolonged Grief in Relatives | Prolonged Grief Disorder scale (PG-13) assessed 12 months after death. PG-13 min = 4, max = 48; Higher scores correlate with increased risk of prolonged grief. | From inclusion to 12 months after the death of the patient |
| Assessment of Quality of Dying by Healthcare Professionals | Quality of Dying and Death questionnaire (QODD-1), as rated on a 0-10 Likert scale. Higher scores correlate with a more satisfactory level of care. | After the death of the patient, assessed up to 28 days |
| Psychological Impact on Healthcare Professionals | Measure of Moral Distress for Healthcare Professionals (MMD-HP). MMD-HP min = 0, max = 432; Higher scores correlate with increased risk of moral distress. | After the death of the patient, assessed up to 28 days |
| Impact on ICU Organization and Staff | Perceived Stressors in Intensive Care Units (PS-ICU) assessing burnout at the end of the inclusion period. PS-ICU min = 0, max = 104; Higher scores correlate with increased risk of stress at work. | Up to 2 years |
| Impact on ICU Organization and Staff | Maslach Burnout Inventory (MBI) assessing burnout at the end of the inclusion period. MBI min = 0, max = 132; Higher scores correlate with increased risk of burnout. | Up to 2 years |
| ID | Term |
|---|---|
| D003643 | Death |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D002985 | Clinical Protocols |
| D010166 | Palliative Care |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D016020 | Epidemiologic Study Characteristics |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D005791 | Patient Care |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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