RCT: Trazodone vs Quetiapine vs Placebo for Treating ICU Delirium (TraQ) (NCT05085808) | Clinical Trial Compass
WithdrawnPhase 4
RCT: Trazodone vs Quetiapine vs Placebo for Treating ICU Delirium (TraQ)
Stopped: PI left institution. Study never started.
United States0Started 2028-03-01
Plain-language summary
The objective of this study is to evaluate the effectiveness of trazodone as compared to quetiapine and placebo, in the management of ICU delirium in adult (\>=18 years old) surgical ICU patients. The investigators will compare outcomes such as delirium incidence and duration, 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, quetiapine, or placebo. The investigators hypothesize participants receiving trazodone will have a shorter duration of delirium, decreased delirium severity, and improved sleep quality compared to participants receiving quetiapine and placebo.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. \>=18-years-old
✓. Admitted to the surgical ICU for \>24 hours
✓. Written informed consent obtained from the patient or their surrogate decision maker.
✓. 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
Exclusion criteria
✕. Acute alcohol or substance abuse withdrawal symptoms/syndrome (i.e., delirium tremens) requiring treatment/intervention (i.e., implementation of the Clinical Institute Withdrawal Assessment for Alcohol (CIWA) protocol, benzodiazepines, alpha-2 agonist, etc.)
✕. Recent torsade de pointes or ventricular arrhythmia
✕. Prolonged QTc syndrome AND/OR prolonged QT-interval (QTc\>500 ms on baseline EKG, performed on the day of randomization)
✕. Active psychosis
What they're measuring
1
Delirium duration using the Confusion Assessment Method for the Intensive Care Unit (CAM-ICU) tool