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

Study acronym: REPSYRE
StatusNot Yet Recruiting
PhaseNot specified
Started
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Record History

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  1. Notable Primary endpoint(s) modified
    • Secondary endpoints revised (5)
    v2
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07705802
Lead Sponsor Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer
Conditions
(from sponsor)
Severe Mental Illness, Severe Mental Disorder
Related terms Frailty, Mental Disorders
Enrollment 2,000 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov