NCT00833300

Haloperidol vs Olanzapine for the Management of ICU Delirium

Haloperidol vs Olanzapine for the Management of ICU Delirium: A Randomized Clinical Trial

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Richard Hall · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this randomized clinical trial is to determine whether haloperidol is superior to olanzapine for the treatment of ICU acquired delirium. The hypothesis is that haloperidol is in fact superior to olanzapine in treating ICU acquired delirium and sustaining delirium free time.

Detailed description

Delirium is defined as a disturbance of consciousness characterized by an acute onset of impaired cognitive function. Although delirium is thought to be common in the Intensive Care Unit (ICU) there are few studies that have evaluated its incidences, risks and outcomes. It has been associated with increased morbidity, and mortality and increased cost to the healthcare system. In addition to the uncertainty of the incidence of ICU delirium, there is a lack of information about the effects that certain pharmacological treatments have on delirious patients. The standard pharmacological treatments for ICU acquired delirium are haloperidol and olanzapine as they have been shown to be equivalent in reducing its incidence. However, optimal dose and regimen have not been well defined. The rationale for this study is to determine whether haloperidol is superior to olanzapine in the treatment of ICU acquired delirium. A secondary objective is to determine the most appropriate dosing regimen for the treatmet. The role of alternative agents quetiapine, risperidone, loxapine and methotrimeprazine will also be examined in a preliminary analysis. Patients who develop agitation or delirium as defined by an Intensive Care Delirium Checklist (ICDSC) score of greater than or equal to 4 meeting all the inclusion criteria and no exclusion criteria will be eligible for randomization. Once randomized they will be screened for ongoing agitation and delirium as well prolongation of the QTc interval greater than 440 msec, development of extrapyramidal symptoms and development of a seizure disorder.

Conditions

• Delirium
• Agitation

Interventions

Type	Name	Description
DRUG	Haloperidol	* 2.5 mg-10 mg IV q6h for 24 hours and 2.5 mg-5 mg IV prn, up to 40mg in 24 hours. * Reassess in 24 hours. * Delirium absent - Continue dose for 24 hours then discontinue. * Delirium present - Increase dose 5 mg-10 mg IV q6h for 24 hours and 2.5 mg-5 mg IV prn, up to 40 mg in 24 hours. * Reassess in 24 hours. * Delirium absent - Continue dose for 24 hours then discontinue. * Delirium present - Discontinue current drug therapy and select one of: 1. Quetiapine up to 100 mg/day 2. Risperidone up to 6 mg/day 3. Loxapine up to 50 mg/day 4. Methotrimeprazine up to 75 mg/day * Reassess in 24 hours. * Delirium absent - Continue for 24 hours then discontinue. * Delirium present - Treatment at discretion of attending physician.
DRUG	Olanzapine	* 2.5 mg-10 mg po/ng/og bid and 2.5 mg po/ng/og prn, up to 20 mg in 24 hours. * Reassess in 24 hours. * Delirium absent - Continue dose for 24 hours then discontinue. * Delirium present - Increase dose 5 mg-10 mg bid and 2.5 mg po/ng/og prn, up to 20 mg in 24 hours. * Reassess in 24 hours. * Delirium absent - Continue dose for 24 hours then discontinue. * Delirium present - Discontinue current drug therapy and select one of: 1. Quetiapine up to 100 mg/day 2. Risperidone up to 6 mg/day 3. Loxapine up to 50 mg/day 4. Methotrimeprazine up to 75 mg/day * Reassess in 24 hours. * Delirium absent - Continue for 24 hours then discontinue. * Delirium present - Treatment at discretion of attending physician.

Timeline

• Start date: 2008-06-01
• Primary completion: 2011-11-01
• Completion: 2011-11-01
• First posted: 2009-02-02
• Last updated: 2012-08-03

Locations

2 sites across 1 country: Canada