Меню
Набор скоро начнётся NCT07705802

Outcome of Patients With Severe Mental Illness in the Intensive Care Unit

— Наблюдательное Severe Mental Illness Severe Mental Disorder

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Observational follow-up.
Кому может быть актуально
Состояния в реестре: Severe Mental Illness, Severe Mental Disorder. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Франция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

Prospective Multicenter Study Assessing the Outcome of Patients With Severe Mental Illness Admitted to Intensive Care Units

Обзор

Severe mental illnesses (SMIs), such as major depression, schizophrenia, and bipolar disorder, carry a significant prevalence among patients admitted to the intensive care unit (ICU), estimated at an average of 19%. Evidence indicates that ICU hospitalization is associated with a poorer prognosis regarding mental health and morbi-mortality compared to hospitalization in conventional wards. Despite this recognized vulnerability, available data remain limited and are often derived from retrospective studies with conflicting results. Some studies have shown that SMIs impact neither critical care nor long-term mortality. Conversely, other research has reported higher hospital mortality, an increase in complications (such as mechanical ventilation and prolonged length of stay), and unfavorable functional outcomes. Regarding specific conditions like septic shock, unexpected findings have been observed, with certain SMIs appearing to be associated with reduced 90-day mortality compared to a matched control population. Patients with SMIs thus represent a vulnerable population whose management in the ICU setting may pose specific challenges. This prospective, multicenter study aims to evaluate mortality and identify predictive factors of mortality among patients with SMIs managed in French ICUs.

Вмешательства

  • Другое Observational follow-up
    Standard care with a 12-month follow-up period to assess long-term outcomes.

Первичные конечные точки

  • All-cause ICU mortality rate [Срок оценки: At ICU discharge (up to 1 month)]
Вторичные конечные точки (5)
  • All-cause mortality rate at specific time points [Срок оценки: At ICU discharge (up to 1 month), 3 months, and 12 months post-ICU admission]
  • Time to death [Срок оценки: Up to 12 months post-ICU admission]
  • Number of ICU readmissions [Срок оценки: 12 months]
  • Glasgow Outcome Scale-Extended (GOSE) score [Срок оценки: At ICU discharge (up to 1 month), 3 months, and 12 months post-initial ICU admission]
  • Clinical Frailty Scale (CFS) score [Срок оценки: At ICU discharge, 3 months, and 12 months post-initial ICU admission]

Критерии участия

Критерии включения

  • Age ≥ 18 years.
  • Admission to a participating ICU.
  • Unscheduled ICU admission for medical management, urgent post-operative care, or due to a complication of elective surgery.
  • Pre-existing diagnosis of a severe mental illness prior to ICU admission, according to DSM-5 criteria: schizophrenia, schizoaffective disorder, severe major depressive episode, chronic depressive disorder, recurrent depressive disorder, or bipolar disorders.
  • Current chronic treatment with psychotropic medication at the time of enrollment (antidepressants, neuroleptics, other antipsychotics, lithium, or antiepileptic drugs used as mood stabilizers).
  • Non-opposition to participate from the patient; if the patient is unable to receive information, non-opposition from a relative/trusted person; for patients under guardianship or curatorship, non-opposition from both the legal guardian and the patient.

Критерии исключения

  • Scheduled ICU admission following elective surgery.
  • Prior enrollment in the REPSYRE study.
  • Inability to speak or understand French.
  • Homeless patients or individuals deprived of liberty.
  • Any other condition or reason that, in the investigator's judgment, might interfere with the evaluation of the study objectives.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Франция · 30 центров
  • Centre Hospitalier Universitaire de Nice — Nice
  • Groupe Hospitalier Littoral Atlantique — La Rochelle
  • Hôpital privé Claude Galien — Quincy-sous-Sénart
  • CHU Ambroise Paré AP-HP — Boulogne-Billancourt
  • Centre Hospitalier Universitaire de Rennes — Rennes
  • Centre Hospitalier Simone Veil — Blois
  • Centre Hospitalier de Cahors — Cahors
  • Centre Hospitalier Bretagne Atlantique de Vannes — Vannes
  • … и ещё 22 центра

Идентификаторы

NCT: NCT07705802 · 2026-CHITS-001 · 2026-A00254-47

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗