Trazodone vs. Quetiapine for the Treatment of ICU Delirium

Stopped early

Conditions studied: Delirium, Delirium of Mixed Origin, Delirium, Sepsis Associated, Delirium in Old Age, Delirium Confusional State, Psych, Morality, Treatment Side Effects

In brief

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.

Key facts

Study ID

NCT05307003

Run by

University of Southern California

People needed

10

Starts

2024-06-01

Expected to finish

2024-06-01

Last updated by the study team

2026-05-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• >=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

You may not qualify if…

• 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 syndrome and/or serotonin syndrome
• Diagnosis of Parkinson's disease or parkinsonism (also referred to as hypokinetic rigidity syndrome)
• Schizophrenia or other psychotic disorder
• Patients in whom CAM-ICU cannot be performed to screen for delirium (i.e., acute encephalopathy, mental retardation, vegetative state, deaf, blind, etc.) [reversible coma (that is, not caused by traumatic brain injury, cerebrovascular accident, or intracranial tumor), defined as RASS -4 or -5 at any point through one ICU day, is NOT an exclusion criterion.]
• Inability to speak or understand English
• Expected to die or transfer out of the ICU within 24 hours
• Acute alcohol or substance abuse withdrawal symptoms/syndrome (i.e., delirium tremens) requiring treatment/intervention (e.g, implementation of the Clinical Institute Withdrawal Assessment for Alcohol (CIWA) protocol, benzodiazepines, alpha-2 agonist, etc.)
• Prolonged QTc syndrome AND/OR prolonged QT-interval (QTc>450 ms for men, and >460 ms for women on ECG performed within 1 month of ICU admission or day of study enrollment)
• Active psychosis [defined as distortion or loss of contact with reality, delusions and/or
• hallucinations (without insight), and/or thought disorder-must be diagnosed by a psychiatrist]
• Patients taking medications with known interactions with either trazodone and/or quetiapine per Pharmacy (e.g., MAOIs (monoamine oxidase inhibitors), SSRIs (selective serotonin reuptake inhibitors; etc.)
• Acute encephalopathy (i.e., hepatic, uremic, etc.)
• Seizure disorder
• Myocardial infarction (MI) within the past 30 days
• Tardive dyskinesia
• Symptomatic hyponatremia
• Terminal state
• Diagnosis of liver disease
• Patients who are strict NPO (nil per os), are a high aspiration risk (defined as frequent nausea/vomiting, ileus, gastric dysmotility disorder, uncontrolled gastroesophageal reflux disease, weakness/deconditioning, diabetes with gastroparesis, not tolerating full tube feeds if being enterally fed (high residual gastric volume >500 cc), elderly patients with waxing/waning mental status), have dysphagia, and/or have difficulty swallowing capsules or solutions as determined by speech therapist
• Currently enrolled and participating in another interventional study

Where it is running

• Keck Hospital of the University of Southern California — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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