RECRUITING

Trazodone vs. Quetiapine for the Treatment of ICU Delirium

Conditions

Delirium Delirium of Mixed Origin Delirium, Sepsis Associated Delirium in Old Age Delirium Confusional State Psych Morality Treatment Side Effects critical care ICU delirium trazodone quetiapine outcomes

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Trazodone vs. Quetiapine for the Treatment of ICU Delirium: A Prospective Observational Pilot Study

Quick Facts

Study Start:2023-04-01

Study Completion:2025-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05307003

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Catherine Kuza, MD, FASA

CONTACT

3234428843

catherine.kuza@med.usc.edu

Subarna Biswas, MD

CONTACT

subarna.biswas@med.usc.edu

Principal Investigator

Catherine Kuza, MD, FASA

PRINCIPAL_INVESTIGATOR

Keck School of Medicine of the University of Southern California

Study Locations (Sites)

Keck Hospital of the University of Southern California

Los Angeles, California, 90033

United States

Collaborators and Investigators

Sponsor: University of Southern California

Catherine Kuza, MD, FASA, PRINCIPAL_INVESTIGATOR, Keck School of Medicine of the University of Southern California

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-01

Study Completion Date2025-12

Study Record Updates

Study Start Date2023-04-01

Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

critical care
ICU delirium
trazodone
quetiapine
outcomes

Additional Relevant MeSH Terms

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