Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2025-12-24 @ 7:38 PM
NCT ID:
NCT05307003
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05307003
Study Brief:
Protocol Section:
NCT05307003