Quetiapine for Delirium Prophylaxis in High-risk Critically Ill Patients

NCT ID: NCT02612948

Last Updated: 2015-11-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2014-06-30

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.

Conditions

Psychomotor Agitation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard Care

Standard care for delerium

Group Type: NO_INTERVENTION

No interventions assigned to this group

Quetiapine

Quetiapine therapy was initiated at 12.5 mg twice daily a. After thefirst dose of quetiapine 12.5 mg, the regimen could then be adjusted by the rounding surgeon. If the surgeon felt benefit from receiving a higher dose of quetiapine the dose could then be increased. Quetiapine was discontinued if adverse events (torsades de pointes or other ventricular tachycardias) occurred. All patients receiving at least one dose of quetiapine were included in the final intention-to-treat analyses. All prescribing decisions were left to the discretion of the rounding surgeon and were not mandated as part of the study.

Group Type: ACTIVE_COMPARATOR

Quetiapine

Intervention Type: DRUG

escalating dose to prevent delerium.

Interventions

Quetiapine

escalating dose to prevent delerium.

Intervention Type: DRUG

Other Intervention Names

Seroquel

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Tennessee Graduate School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Brian Daley

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Brian Daley

Role: PRINCIPAL_INVESTIGATOR

University General Surgeons, P.C.

Locations

University of Tennessee Medical Center

Knoxville, Tennessee, United States

Countries

United States

Other Identifiers

3709

Identifier Type: -

Identifier Source: org_study_id