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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-A00848-49 | Other Identifier | RCB number |
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no recruitment
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This study concerns the nearest relatives of patients who have passed away within 3 days of admission to an ICU due to: (1) brain death with multiple organ donation +/- tissues or (2) death via limitation and / or cessation of active treatment (LATA) without brain death or (3) sudden death of a previously healthy patient (no physical or mental limitations; MacCabe score = 0) within 3 days of admission to ICU without LATA nor brain death. Our primary objective is to determine the proportion of nearest relatives at risk for post traumatic stress disorder as defined by an Impact of Event Scale score greater than 37, and to compare this factor between the three above-mentioned groups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brain death with organ donation | Participants in this group are the nearest relatives (or "person-of-trust") of a patient who has passed away within 3 days of admission to an intensive care unit. The cause of death includes brain death with multiple organ donation +/- tissues. |
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| Limitation/cessation of active treatment | Participants in this group are the nearest relatives (or "person-of-trust") of a patient who has passed away within 3 days of admission to an intensive care unit. The cause of death includes limitation/cessation of active treatment without brain death. |
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| Sudden death | Participants in this group are the nearest relatives (or "person-of-trust") of a patient who has passed away within 3 days of admission to an intensive care unit. The cause of death was sudden death of a previously healthy patient (no physical or mental limitations; MacCabe score = 0) within 3 days of admission to ICU without LATA nor brain death. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IES-R and HDAS scores | Other | The Impact of Event Scale and Hospital Depression and Anxiety Score questionnaires are administered to participants. |
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| Measure | Description | Time Frame |
|---|---|---|
| IES-R > 37: yes/no | Impact of Event Scale score greater than 37: yes/no | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| IES-R | Impact of Event scale score (score varying from 0 (no risk of post traumatic stress) to 88 (highest risk of post traumatic stress)). | 6 weeks |
| HDAS score | Hospital Depression and Anxiety Score (varies from 0 to 21). A score >8 indicates clinically significant anxiety/depression. |
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Inclusion Criteria:
Exclusion Criteria:
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Participants are the nearest relatives (or "person-of-trust") of a patient who has passed away in an intensive care unit (ICU) due to: (1) brain death with multiple organ donation +/- tissues or (2) death via limitation and / or cessation of active treatment (LATA) without brain death or (3) sudden death of a previously healthy patient (no physical or mental limitations; MacCabe score = 0) within 3 days of admission to ICU without LATA nor brain death
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| Name | Affiliation | Role |
|---|---|---|
| Jean Yves Lefrant, MD PhD | Centre Hospitalier Universitaire de Nīmes | Study Director |
| Caroline Boutin, MD | Centre Hospitalier Universitaire de Nīmes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Beaujon -APHP | Clichy | France | ||||
| Assistance Publique - Hopitaux de Marseille |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D001926 | Brain Death |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D001927 | Brain Diseases |
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| 6 weeks |
| Marseille |
| France |
| CHU Lapeyronie | Montpellier | 34295 | France |
| Hôpital Gui De Chauliac (CHU de Montpellier) | Montpellier | 34295 | France |
| Centre Hospitalier Universitaire de Nîmes | Nîmes | 30029 | France |
| Hôpital Kremlin Bicêtre - APHP | Paris | France |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D003128 | Coma |
| D014474 | Unconsciousness |
| D003244 | Consciousness Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D003643 | Death |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |