Outcome of Patients With Severe Mental Illness in the Intensive Care Unit
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCentre Hospitalier Intercommunal de Toulon La Seyne sur Mer
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Patients with severe mental illnesses admitted to the ICU for unscheduled medical management, urgent post-operative care, or due to a complication of elective surgery.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Observational follow-up
Other interventionStandard care with a 12-month follow-up period to assess long-term outcomes.
Treatment groups
2,000 Participants
are divided into 1 treatment groupGroup A: Patients with severe mental illness1 intervention
Trial outcomes
Primary outcomes
1
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
1
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 admission2
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 admission3
Number of ICU readmissions
Count of subsequent unscheduled admissions to the ICU for each patient.
Time frame
12 months4
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 admissionSponsors and contacts
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Source ClinicalTrials.gov
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