Haloperidol vs Olanzapine for the Management of ICU Delirium
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00833300|
Recruitment Status : Terminated
First Posted : February 2, 2009
Last Update Posted : August 3, 2012
|Condition or disease||Intervention/treatment||Phase|
|Delirium Agitation||Drug: Haloperidol Drug: Olanzapine||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Haloperidol vs Olanzapine for the Management of ICU Delirium: A Randomized Clinical Trial|
|Study Start Date :||June 2008|
|Actual Primary Completion Date :||November 2011|
|Actual Study Completion Date :||November 2011|
Active Comparator: 1
Other Name: Haldol
Active Comparator: 2
- Resolution of delirium as indicated by an Intensive Care Delirium Screening Checklist score of less than 4 [ Time Frame: Every 24 hours ]
- Delirium free days (i.e. time from resolution of delirium to ICU discharge) [ Time Frame: Every 24 hours ]
- Incidence of treatment failure at 48 hours [ Time Frame: 48 hours ]
- Requirement for rescue medication [ Time Frame: Every 24 hours ]
- Type of rescue medication [ Time Frame: Every 24 hours ]
- Mortality [ Time Frame: Time of death ]
- If on mechanical ventilation at time delirium develops, duration of mechanical ventilation [ Time Frame: Every 24 hours ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00833300
|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||Nova Scotia Health Authority|