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Haloperidol vs Olanzapine for the Management of ICU Delirium

NCT00833300 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2012-08-03

No results posted yet for this study

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.

Conditions

  • Delirium
  • Agitation

Interventions

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.

Sponsors & Collaborators

  • Dalhousie University

    collaborator OTHER

  • Richard Hall

    lead OTHER

Principal Investigators

  • Richard Hall, MD, FRCPC, FCCP · Nova Scotia Health Authority

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2011-11-30
Completion
2011-11-30

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00833300 on ClinicalTrials.gov