Quetiapine for Delirium Prophylaxis in High-risk Critically Ill Patients

Psychomotor Agitation Clinical Trial

Official title:

Quetiapine for Delirium Prophylaxis in High-risk Critically Ill Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02612948
• Other study ID #: 3709
• Status: Completed
• Phase: Phase 4
• First received: November 19, 2015
• Last updated: November 21, 2015
• Start date: November 2013
• Est. completion date: June 2014

Study information

• Verified date: November 2015
• Source: University of Tennessee Graduate School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 100 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Critical Illness
• Psychomotor Agitation

Intervention

Drug:
• Quetiapine
escalating dose to prevent delerium.

Locations

Country	Name	City	State
United States	University of Tennessee Medical Center	Knoxville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
University of Tennessee Graduate School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of delerium	ICU length of stay	One year	No