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Recruiting NCT05307003

Trazodone vs. Quetiapine for the Treatment of ICU Delirium

Trial Parameters

Condition Delirium
Sponsor University of Southern California
Study Type OBSERVATIONAL
Phase N/A
Enrollment 60
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2023-04-01
Completion 2025-08
Interventions
TrazodoneQuetiapine

Brief Summary

This is a single-center, prospective observational pilot study. The objective of this study is to evaluate the effectiveness of trazodone as compared to quetiapine, in the management of ICU delirium in adult (\>=18 years old) surgical and medical ICU patients. The investigators will compare outcomes such as delirium duration, delirium-free days, coma-free days, in-hospital mortality, 28-day mortality, hospital length of stay (LOS), ICU LOS, mechanical ventilator days, complications, adverse effects, rescue medication use, delirium symptom severity, sleep duration, and sleep quality among participants receiving trazodone or quetiapine. The investigators hypothesize participants receiving trazodone will be associated with a shorter duration of delirium, decreased delirium severity, and improved sleep quality compared to participants receiving quetiapine.

Eligibility Criteria

Inclusion Criteria: * \>=18-years-old * Admitted to the surgical ICU for \>24 hours * Diagnosis of ICU delirium defined by positive CAM-ICU score AND exhibiting symptomatic delirium (i.e., combative, pulling at lines, a danger to self or others, inability to sleep, hallucinations, etc.), thus, requiring the need for pharmacologic intervention as determined by the attending intensivist * Receiving either quetiapine or trazodone for the treatment of delirium Exclusion Criteria: * Presence of an acute neurologic condition (i.e., acute cerebrovascular accident, intracranial tumor, traumatic brain injury, etc.) on ICU admission. History of stroke or other neurological condition(s) without cognitive impairment is not an exclusion criterion. * Pregnancy/lactation * History of ventricular arrhythmia including torsade de pointes or second- and third-degree heart block * Allergy/hypersensitivity reaction to trazodone and/or quetiapine * Diagnosis of dementia * History of neuroleptic malignant sy

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