Haloperidol vs Olanzapine for the Management of ICU Delirium
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
|Official Title:||Haloperidol vs Olanzapine for the Management of ICU Delirium: A Randomized Clinical Trial|
- Resolution of delirium as indicated by an Intensive Care Delirium Screening Checklist score of less than 4 [ Time Frame: Every 24 hours ] [ Designated as safety issue: No ]
- Delirium free days (i.e. time from resolution of delirium to ICU discharge) [ Time Frame: Every 24 hours ] [ Designated as safety issue: No ]
- Incidence of treatment failure at 48 hours [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
- Requirement for rescue medication [ Time Frame: Every 24 hours ] [ Designated as safety issue: No ]
- Type of rescue medication [ Time Frame: Every 24 hours ] [ Designated as safety issue: No ]
- Mortality [ Time Frame: Time of death ] [ Designated as safety issue: No ]
- If on mechanical ventilation at time delirium develops, duration of mechanical ventilation [ Time Frame: Every 24 hours ] [ Designated as safety issue: No ]
|Study Start Date:||June 2008|
|Study Completion Date:||November 2011|
|Primary Completion Date:||November 2011 (Final data collection date for primary outcome measure)|
Active Comparator: 1
Other Name: Haldol
Active Comparator: 2
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.
|Canada, Nova Scotia|
|Halifax Infirmary; Queen Elizabeth II Health Sciences Centre|
|Halifax, Nova Scotia, Canada|
|Victoria General Hospital; Queen Elizabeth II Health Sciences Centre|
|Halifax, Nova Scotia, Canada|
|Principal Investigator:||Richard Hall, MD, FRCPC, FCCP||Capital District Health Authority, Canada|