Trazodone vs. Quetiapine for the Treatment of ICU Delirium
A legfontosabb adatok
- Ki végzi
- University of Southern California
- Hol
- Los Angeles (Egyesült Államok)A helyszín megnézése
- Azonosító
- Állapot
- Leállítva
- Résztvevők
- 10 fő vett részt
- Kezdés
- 2024. jún. 1.
- Befejezés
- 2024. jún. 1.
- A vizsgálat típusa
- Megfigyeléses, 2 csoport
- A vizsgált kezelések
- Trazodone
- Quetiapine
- A regiszteradat frissítve
- 2026. május 4.
- Miért állt le
- PI left institution. No one resumed the project.
Ki vehet részt
- Életkor
- 18 év felett
- Nem
- Nők és férfiak
- Egészséges önkéntesek
- Nem vehetnek részt
A regiszter feltételei, szó szerint
Mind a 32 feltétel megnézéseKevesebb
Ki vehet részt
- >=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
Ki nem vehet részt
- 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.)
- Patients who have received both trazodone and quetiapine in the management of their 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
- 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
- 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.)
- hallucinations (without insight), and/or thought disorder-must be diagnosed by a psychiatrist]
- Seizure disorder
- Myocardial infarction (MI) within the past 30 days
- 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
- Patients who have had a history of serotonin syndrome
- 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)
- Pregnancy/lactation
- 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
- Active psychosis [defined as distortion or loss of contact with reality, delusions and/or
- Acute encephalopathy (i.e., hepatic, uremic, etc.)
- Tardive dyskinesia
- Symptomatic hyponatremia
- Terminal state
- Currently enrolled and participating in another interventional study
- Patients who were enrolled in the study once, are not eligible for re-enrollment if they are readmitted to the ICU
Helyszínek itt: Egyesült Államok
- Keck Hospital of the University of Southern CaliforniaLos Angeles, Egyesült Államok
A vizsgálatról
Mit akar kideríteni a vizsgálat
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.
A vizsgálat 2 csoportja
- Quetiapine
Patients diagnosed with delirium who received quetiapine for treatment. * Start study medication at 25 mg daily PO ; may increase to BID (twice a day) or TID (three times a day) if RASS\>=2 or rescue medication must be given; thereafter, if med is TID, dose can be increased by increment of 50 mg q12 hr if RASS\>=2 and/or \>1 dose of rescue medication is given within 24 hours \[max dose 200 mg/day\] * dose can be reduced/discontinued per discretion of ICU attending if delirium improving, patient experiences AE (adverse effects) likely related to study drug, after 14 days of treatment, or patient is discharged from ICU * dose should be held if RASS is -3 to -5/comatose/unresponsive or sudden acute change in mental status
- Trazodone
Patients diagnosed with delirium who received trazodone for treatment. * Start study medication at 25 mg daily PO ; may increase to BID or TID if RASS\>=2 or rescue medication must be given; thereafter, if med is TID, dose can be increased by increment of 50 mg q12 hr if RASS\>=2 and/or \>1 dose of rescue medication is given within 24 hours \[max dose 200 mg/day\] * dose can be reduced/discontinued per discretion of ICU attending if delirium improving, patient experiences AE likely related to study drug, after 14 days of treatment, or patient is discharged from ICU * dose should be held if RASS is -3 to -5/comatose/unresponsive or sudden acute change in mental status
Adatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- Hivatalos cím
- Trazodone vs. Quetiapine for the Treatment of ICU Delirium: A Prospective Observational Pilot Study
- A regiszteradat frissítve
- 2026. május 4.