Haloperidol vs Olanzapine for the Management of ICU Delirium
NCT ID: NCT00833300
Last Updated: 2012-08-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
200 participants
INTERVENTIONAL
2008-06-30
2011-11-30
Brief Summary
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Detailed Description
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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1
Haloperidol
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.
2
Olanzapine
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.
Interventions
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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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients screened for delirium using the ICDSC with a score greater than or equal to 4 or with clinical manifestations of delirium.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Dalhousie University
OTHER
Richard Hall
OTHER
Responsible Party
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Richard Hall
Dr. Richard Hall MD FRCPC FCCP
Principal Investigators
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Richard Hall, MD, FRCPC, FCCP
Role: PRINCIPAL_INVESTIGATOR
Nova Scotia Health Authority
Locations
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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
Countries
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References
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Bergeron N, Skrobik Y, Dubois MJ. Delirium in critically ill patients. Crit Care. 2002 Jun;6(3):181-2. doi: 10.1186/cc1482. Epub 2002 Apr 5.
Lacasse H, Perreault MM, Williamson DR. Systematic review of antipsychotics for the treatment of hospital-associated delirium in medically or surgically ill patients. Ann Pharmacother. 2006 Nov;40(11):1966-73. doi: 10.1345/aph.1H241. Epub 2006 Oct 17.
Jaber S, Chanques G, Altairac C, Sebbane M, Vergne C, Perrigault PF, Eledjam JJ. A prospective study of agitation in a medical-surgical ICU: incidence, risk factors, and outcomes. Chest. 2005 Oct;128(4):2749-57. doi: 10.1378/chest.128.4.2749.
Ouimet S, Kavanagh BP, Gottfried SB, Skrobik Y. Incidence, risk factors and consequences of ICU delirium. Intensive Care Med. 2007 Jan;33(1):66-73. doi: 10.1007/s00134-006-0399-8. Epub 2006 Nov 11.
Jacobi J, Fraser GL, Coursin DB, Riker RR, Fontaine D, Wittbrodt ET, Chalfin DB, Masica MF, Bjerke HS, Coplin WM, Crippen DW, Fuchs BD, Kelleher RM, Marik PE, Nasraway SA Jr, Murray MJ, Peruzzi WT, Lumb PD; Task Force of the American College of Critical Care Medicine (ACCM) of the Society of Critical Care Medicine (SCCM), American Society of Health-System Pharmacists (ASHP), American College of Chest Physicians. Clinical practice guidelines for the sustained use of sedatives and analgesics in the critically ill adult. Crit Care Med. 2002 Jan;30(1):119-41. doi: 10.1097/00003246-200201000-00020. No abstract available.
Milbrandt EB, Deppen S, Harrison PL, Shintani AK, Speroff T, Stiles RA, Truman B, Bernard GR, Dittus RS, Ely EW. Costs associated with delirium in mechanically ventilated patients. Crit Care Med. 2004 Apr;32(4):955-62. doi: 10.1097/01.ccm.0000119429.16055.92.
Pandharipande P, Shintani A, Peterson J, Pun BT, Wilkinson GR, Dittus RS, Bernard GR, Ely EW. Lorazepam is an independent risk factor for transitioning to delirium in intensive care unit patients. Anesthesiology. 2006 Jan;104(1):21-6. doi: 10.1097/00000542-200601000-00005.
Skrobik YK, Bergeron N, Dumont M, Gottfried SB. Olanzapine vs haloperidol: treating delirium in a critical care setting. Intensive Care Med. 2004 Mar;30(3):444-9. doi: 10.1007/s00134-003-2117-0. Epub 2003 Dec 19.
Plaschke K, von Haken R, Scholz M, Engelhardt R, Brobeil A, Martin E, Weigand MA. Comparison of the confusion assessment method for the intensive care unit (CAM-ICU) with the Intensive Care Delirium Screening Checklist (ICDSC) for delirium in critical care patients gives high agreement rate(s). Intensive Care Med. 2008 Mar;34(3):431-6. doi: 10.1007/s00134-007-0920-8. Epub 2007 Nov 9.
Devlin JW, Fong JJ, Schumaker G, O'Connor H, Ruthazer R, Garpestad E. Use of a validated delirium assessment tool improves the ability of physicians to identify delirium in medical intensive care unit patients. Crit Care Med. 2007 Dec;35(12):2721-4; quiz 2725. doi: 10.1097/01.ccm.0000292011.93074.82.
Rea RS, Battistone S, Fong JJ, Devlin JW. Atypical antipsychotics versus haloperidol for treatment of delirium in acutely ill patients. Pharmacotherapy. 2007 Apr;27(4):588-94. doi: 10.1592/phco.27.4.588.
Bergeron N, Dubois MJ, Dumont M, Dial S, Skrobik Y. Intensive Care Delirium Screening Checklist: evaluation of a new screening tool. Intensive Care Med. 2001 May;27(5):859-64. doi: 10.1007/s001340100909.
Ely EW, Truman B, Shintani A, Thomason JW, Wheeler AP, Gordon S, Francis J, Speroff T, Gautam S, Margolin R, Sessler CN, Dittus RS, Bernard GR. Monitoring sedation status over time in ICU patients: reliability and validity of the Richmond Agitation-Sedation Scale (RASS). JAMA. 2003 Jun 11;289(22):2983-91. doi: 10.1001/jama.289.22.2983.
Teasdale G, Jennett B. Assessment of coma and impaired consciousness. A practical scale. Lancet. 1974 Jul 13;2(7872):81-4. doi: 10.1016/s0140-6736(74)91639-0. No abstract available.
Dubois MJ, Bergeron N, Dumont M, Dial S, Skrobik Y. Delirium in an intensive care unit: a study of risk factors. Intensive Care Med. 2001 Aug;27(8):1297-304. doi: 10.1007/s001340101017.
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Korevaar JC, van Munster BC, de Rooij SE. Risk factors for delirium in acutely admitted elderly patients: a prospective cohort study. BMC Geriatr. 2005 Apr 13;5:6. doi: 10.1186/1471-2318-5-6.
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Brust JC. Acute neurologic complications of drug and alcohol abuse. Neurol Clin. 1998 May;16(2):503-19. doi: 10.1016/s0733-8619(05)70074-8.
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Other Identifiers
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Control No.:121747
Identifier Type: -
Identifier Source: secondary_id
File No.: 9427-C2659-22C
Identifier Type: -
Identifier Source: secondary_id
CDHA-RS/2009-001
Identifier Type: -
Identifier Source: org_study_id