Quetiapine for Delirium Prophylaxis in High-risk Critically Ill Patients

NCT02612948 | Completed Phase 4

• 1 other identifier: 3709
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Psychomotor Agitation

Outcome Measures

Primary Outcomes (1)

• Incidence of delerium

  ICU length of stay

  One year

Study Arms (2)

Standard Care

NO INTERVENTION

Standard care for delerium

Quetiapine

ACTIVE COMPARATOR

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.

Drug: Quetiapine

Interventions

Quetiapine DRUG

escalating dose to prevent delerium.

Also known as: Seroquel

Quetiapine

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Tennessee Graduate School of Medicine: lead

Study Sites (1)

University of Tennessee Medical Center

Knoxville, Tennessee, 37922, United States

Location

MeSH Terms

Conditions

Psychomotor Agitation

Interventions

Quetiapine Fumarate

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Psychomotor Disorders; Neurobehavioral Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Brian Daley

  University General Surgeons, P.C.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 19, 2015
• First Posted: November 24, 2015
• Study Start: November 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: November 24, 2015

Record last verified: 2015-11

Locations

US (1)