Prospective Multicenter Study Assessing the Outcome of Patients With Severe Mental Illness Admitted to Intensive Care Units
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 2,000
- 试验地点
- 29
- 主要终点
- Vital status
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Patients with severe mental illness
Patients with severe mental illnesses (Schizophrenia, schizoaffective disorder, severe major depressive episode, chronic depressive disorder, recurrent depressive disorder, or bipolar disorders) admitted to the intensive care unit for unscheduled medical management, urgent post-operative care, or due to a complication of elective surgery.
干预措施: Observational follow-up (Other)
结局指标
主要结局
Vital status
时间窗: At ICU discharge (up to 1 month)
Assessment of patient vital status (alive or deceased) at the time of intensive care unit (ICU) discharge.
All-cause ICU mortality rate
时间窗: At ICU discharge (up to 1 month)
Assessment of patient vital status (alive or deceased) at the time of intensive care unit (ICU) discharge.
次要结局
- Vital status at specific time points(At ICU discharge, 3 months, and 12 months post-ICU admission)
- Time to death(Up to 12 months post-ICU admission)
- Number of ICU readmissions(12 months)
- Glasgow Outcome Scale-Extended (GOSE) score(At ICU discharge, 3 months, and 12 months post-initial ICU admission)
- Clinical Frailty Scale (CFS) score(At ICU discharge, 3 months, and 12 months post-initial ICU admission)
- All-cause mortality rate at specific time points(At ICU discharge (up to 1 month), 3 months, and 12 months post-ICU admission)
- Glasgow Outcome Scale-Extended (GOSE) score(At ICU discharge (up to 1 month), 3 months, and 12 months post-initial ICU admission)