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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• \>=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

Locations
United States
California
Keck Hospital of the University of Southern California
RECRUITING
Los Angeles
Contact Information
Primary
Catherine Kuza, MD, FASA
catherine.kuza@med.usc.edu
3234428843
Backup
Subarna Biswas, MD
subarna.biswas@med.usc.edu
Time Frame
Start Date: 2023-04-01
Estimated Completion Date: 2025-12
Participants
Target number of participants: 60
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: University of Southern California

This content was sourced from clinicaltrials.gov