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

N/ANot Yet RecruitingNCT07705802

Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer2,000 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

2,000

Conditions

Severe Mental Illness Severe Mental Disorder

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Locations (30)

Centre Hospitalier Universitaire de Nice

Nice, Alpes-Maritimes, France

Groupe Hospitalier Littoral Atlantique

La Rochelle, Charente-Maritime, France

Hôpital privé Claude Galien

Quincy-sous-Sénart, Essonne, France

CHU Ambroise Paré AP-HP

Boulogne-Billancourt, Hauts-de-Seine, France

Centre Hospitalier Universitaire de Rennes

Rennes, Ille-et-Vilaine, France

Outcomes

Primary Outcomes

All-cause ICU mortality rate

Assessment of patient vital status (alive or deceased) at the time of intensive care unit (ICU) discharge.

Time frame: At ICU discharge (up to 1 month)

Secondary Outcomes

All-cause mortality rate at specific time points

Assessment of patient vital status (alive or deceased) for each specified time point.

Time frame: At ICU discharge (up to 1 month), 3 months, and 12 months post-ICU admission

Time to death

Evaluation of the exact survival time from ICU admission up to the end of the 12-month follow-up period.

Time frame: Up to 12 months post-ICU admission

Number of ICU readmissions

Count of subsequent unscheduled admissions to the ICU for each patient.

Time frame: 12 months

Glasgow Outcome Scale-Extended (GOSE) score

Evaluation of global functioning and recovery using the GOSE score. The score ranges from 1 to 8, where higher scores indicate a better functional outcome.

Time frame: At ICU discharge (up to 1 month), 3 months, and 12 months post-initial ICU admission

Clinical Frailty Scale (CFS) score

Evaluation of the patient's overall level of fitness and frailty using the CFS. The scale ranges from 1 to 9, where higher scores indicate greater frailty.

Time frame: At ICU discharge, 3 months, and 12 months post-initial ICU admission