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

Observational Severe Mental Illness Severe Mental Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Observational follow-up.
Who it may be relevant to
Registry conditions: Severe Mental Illness, Severe Mental Disorder. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

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.

Interventions

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

Primary outcome measures

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

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 30 centers
  • 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
  • … and 22 more centers

Identifiers

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

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗