DeliriumNCT00833300
Haloperidol vs Olanzapine for the Management of ICU Delirium
A study testing Haloperidol and Olanzapine in people with Delirium and Agitation, run by Richard Hall at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Haloperidol and Olanzapine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesCanada
- Study dates
- Jun 2008to Nov 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Halifax Infirmary; Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia
Victoria General Hospital; Queen Elizabeth II Health Sciences Centre
Halifax, Nova Scotia
About this study
Official title: Haloperidol vs Olanzapine for the Management of ICU Delirium: A Randomized Clinical Trial
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.
Read the 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 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.
- Being tested
- Haloperidol, Olanzapine
- Keywords
- Delirium, Agitation, Intensive Care, Critical Care, Antipsychotics, Olanzapine, Haloperidol
- Medical subject headings
- Delirium, Psychomotor Agitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HaloperidolDrug
Also called Haldol
- 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:
- Quetiapine up to 100 mg/day
- Risperidone up to 6 mg/day
- Loxapine up to 50 mg/day
- 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.
OlanzapineDrug
Also called Zyprexa, Zyprexa Zydis, Novo-Olanzapine, PMS-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:
- Quetiapine up to 100 mg/day
- Risperidone up to 6 mg/day
- Loxapine up to 50 mg/day
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Haloperidol Receives: Drug: Haloperidol |
| 2 | Active comparator | Olanzapine Receives: Drug: Olanzapine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resolution of delirium as indicated by an Intensive Care Delirium Screening Checklist score of less than 4
Measured: Every 24 hours
Secondary outcomes (6)
Delirium free days (i.e. time from resolution of delirium to ICU discharge)
Measured: Every 24 hours
Incidence of treatment failure at 48 hours
Measured: 48 hours
Requirement for rescue medication
Measured: Every 24 hours
Type of rescue medication
Measured: Every 24 hours
Mortality
Measured: Time of death
If on mechanical ventilation at time delirium develops, duration of mechanical ventilation
Measured: Every 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2009 (estimated)
- Study startJun 2008
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for DeliriumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Richard Hall
- Sponsor type
- University, hospital or other
- Collaborators
- Dalhousie University
- Responsible party
- Sponsor-investigator, Richard Hall, Nova Scotia Health Authority
- Investigators
- Richard Hall, MD, FRCPC, FCCP, Principal investigator, Nova Scotia Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00833300
- Sponsor's protocol ID
- CDHA-RS/2009-001
- Other IDs
- Control No.:121747, File No.: 9427-C2659-22C
- Status last verified
- Aug 2012
- First submitted
- 30 Jan 2009
- Last updated
- 3 Aug 2012
- Results posted
- No
Publications
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.
PubMed 12133171Lacasse 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.
PubMed 17047137Jaber 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.
PubMed 16236951Ouimet 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.
PubMed 17102966Jacobi 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.
PubMed 11902253Milbrandt 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.
PubMed 15071384Pandharipande 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.
PubMed 16394685Skrobik 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.
PubMed 14685663Plaschke 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.
PubMed 17994221Devlin 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.
PubMed 18074477Rea 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.
PubMed 17381385Bergeron 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.
PubMed 11430542Ely 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.
PubMed 12799407Teasdale 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.
PubMed 4136544Dubois 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.
PubMed 11511942
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Haloperidol vs Olanzapine for the Management of ICU Delirium: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT00833300
- Acronym / sponsor ID
- CDHA-RS/2009-001
- Keywords
- Delirium, Agitation, Intensive Care, Critical Care, Antipsychotics, Olanzapine, Haloperidol
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Richard HallUniversity, hospital or other
- Collaborators
- Dalhousie University
- Study start
- Jun 2008
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 2 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: HaloperidolHaloperidol |
| 2 | Active comparator | Drug: OlanzapineOlanzapine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HaloperidolAlso: Haldol* 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 | 1 |
| OlanzapineAlso: Zyprexa, Zyprexa Zydis, Novo-Olanzapine, PMS-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. | Drug | 2 |
Primary outcome
Resolution of delirium as indicated by an Intensive Care Delirium Screening Checklist score of less than 4
Time frame: Every 24 hours
6 secondary outcomes
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
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2012.
- Background: PubMed 12133171Bergeron 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.
- Background: PubMed 17047137Lacasse 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.
- Background: PubMed 16236951Jaber 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.
- Background: PubMed 17102966Ouimet 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.
- Background: PubMed 11902253Jacobi 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.
- Background: PubMed 15071384Milbrandt 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.
- Background: PubMed 16394685Pandharipande 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.
- Background: PubMed 14685663Skrobik 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.
- Background: PubMed 17994221Plaschke 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.
- Background: PubMed 18074477Devlin 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.
- Background: PubMed 17381385Rea 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.
- Background: PubMed 11430542Bergeron 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Hall, MD, FRCPC, FCCP principal investigator
Nova Scotia Health Authority
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Haloperidol and Olanzapine in people with Delirium and Agitation, run by Richard Hall at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resolution of delirium as indicated by an Intensive Care Delirium Screening Checklist score of less than 4 (time frame: Every 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00833300, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2012.