Trazodone vs. Quetiapine for the Treatment of ICU Delirium

Launched by UNIVERSITY OF SOUTHERN CALIFORNIA · Mar 23, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at two medications, trazodone and quetiapine, to see which one works better for treating delirium in patients who are in the Intensive Care Unit (ICU). Delirium is a serious condition that affects a person's mental state, causing confusion and difficulty thinking clearly. The study will involve adults aged 18 and older who have been in the surgical ICU for more than 24 hours and have been diagnosed with ICU delirium. Participants will be treated with either trazodone or quetiapine, and the researchers will compare how long the delirium lasts, how severe it is, and how well patients sleep, among other things.

To be eligible for the study, patients need to show signs of delirium and require medication for treatment, but there are some specific criteria that may exclude them, such as having certain neurological conditions or being unable to communicate in English. Participants can expect to receive one of the two medications and be monitored closely for their symptoms and any side effects. This study is important because it aims to find out which medication might help patients recover from delirium more effectively, potentially leading to better care for those in the ICU.

Gender

ALL

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 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
• • Patients who have received both trazodone and quetiapine in the management of their delirium
• • Patients who have had a history of serotonin syndrome
• • Patients who were enrolled in the study once, are not eligible for re-enrollment if they are readmitted to the ICU