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Quetiapine for Delirium Prophylaxis in High-risk Critically Ill Patients

Quetiapine for Delirium Prophylaxis in High-risk Critically Ill Patients

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02612948
Enrollment
82
Registered
2015-11-24
Start date
2013-11-30
Completion date
2014-06-30
Last updated
2015-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psychomotor Agitation

Brief summary

Scheduled, low-dose quetiapine is effective in preventing delirium in high-risk critically ill, trauma/surgical patients. Prophylaxis also reduced ventilator duration and ICU length of stay.

Detailed description

Objective: To evaluate the efficacy of scheduled quetiapine for delirium prophylaxis in critically ill, trauma/surgical patients identified as high-risk for delirium utilizing a validated prediction model. Design: Prospective, open-label, single-center study. Setting: Trauma/surgical intensive care unit at an academic medical center. Patients: Eighty two adult trauma/surgical patients who were admitted to the intensive care unit and were at high-risk for the development of delirium (PRE-DELIRIC Score ≥50%, past medical history of dementia, past medical history of alcohol misuse, or past medical history of drug abuse). Interventions: Patients were randomized by unit location to receive pharmacologic prophylaxis for delirium (quetiapine 12.5 mg every 12 hours) or no pharmacologic prophylaxis for delirium within forty-eight hours of admission to the intensive care unit. Measurements: The primary end point was the incidence of delirium during admission to the intensive care unit (ICU). Secondary end points included time to onset of delirium, ICU and hospital lengths of stay, ICU and hospital mortality, duration of mechanical ventilation, and adverse events. Delirium was assessed using the confusion assessment method for the intensive care unit.

Interventions

DRUGQuetiapine

escalating dose to prevent delerium.

Sponsors

University of Tennessee Graduate School of Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes

Inclusion criteria

* Trauma/surgical patients admitted to the trauma/surgical ICU

Exclusion criteria

* sustained RASS of -4/-5 during the complete ICU admission * presence of a condition preventing delirium assessment * anticipated or known ICU length of stay of less than 48 hours * taking antipsychotics prior to admission * history of schizophrenia, epilepsy, parkinsonism, or levodopa treatment * primary neurologic event/injury with GCS ≤ 9 during the first 48 hours of ICU * current treatment with a continuous infusion neuromuscular blocking agent * pregnancy * screened positive for delirium upon admission to the ICU.

Design outcomes

Primary

MeasureTime frameDescription
Incidence of deleriumOne yearICU length of stay

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026