Status:

TERMINATED

Haloperidol vs Olanzapine for the Management of ICU Delirium

Lead Sponsor:

Richard Hall

Collaborating Sponsors:

Dalhousie University

Conditions:

Delirium

Agitation

Eligibility:

All Genders

18+ years

Phase:

NA

Brief 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 su...

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 a...

Eligibility Criteria

Inclusion

  • All patients who are 18 years or older who are admitted for more than 24 hours to the ICU.
  • Patients screened for delirium using the ICDSC with a score greater than or equal to 4 or with clinical manifestations of delirium.

Exclusion

  • Patients unlikely to survive 24 hours.
  • Patients with a primary neurologic reason (i.e. stroke, dementia-related psychosis) for ICU admission.
  • Patients with QTc interval greater than 440 msec.
  • Pregnant patients.
  • Patients who are breast feeding.
  • Patients in whom haloperidol, or olanzapine is contraindicated.
  • Patients allergic to haloperidol, olanzapine, quetiapine, risperidone, loxapine or methotrimeprazine.
  • Patients who do not have a urinary catheter.
  • Patients who have received haloperidol, olanzapine, quetiapine, risperidone, loxapine or methotrimeprazine within 14 days.
  • Patients unable to undergo assessment (i.e. patients with developmental disability or mental incapacity prior to ICU admission).
  • Prolonged (greather than 24 hours) comatose patients who have a defined structural reason for their decreased level of consciousness.

Key Trial Info

Start Date :

June 1 2008

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

November 1 2011

Estimated Enrollment :

200 Patients enrolled

Trial Details

Trial ID

NCT00833300

Start Date

June 1 2008

End Date

November 1 2011

Last Update

August 3 2012

Active Locations (2)

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Page 1 of 1 (2 locations)

1

Halifax Infirmary; Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia, Canada

2

Victoria General Hospital; Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia, Canada