DeliriumNCT00699946
Prophylactic Olanzapine Versus Placebo for Prevention of Postoperative Delirium After Joint Replacement Surgery
A study testing olanzapine in people with Delirium, run by The New England Baptist Hospital at 1 site in United States.
Trial summary
In this study we wanted to determine if perioperative administration of olanzapine prior to knee or hip replacement surgery in high risk patients would prevent the onset of postoperative delirium. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Delirium
- What is being tested?
- olanzapine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 495 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2005to Oct 2007
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- High risk for delirium age > 65 history of delirium medical comorbidities ability to give informed consent
Who cannot join
- Dementia Alcohol abuse Current use of an antipsychotic Allergy to olanzapine
Trial locations and contacts
1 site in 1 country.
United States1 site
New England Baptist Hospital
Boston, Massachusetts, 02120
About this study
Official title: A Double-Blind, Randomized, Placebo-Controlled Study of Perioperative Administration of Olanzapine to Prevent Postoperative Delirium in Joint Replacement Patients
In this study we wanted to determine if perioperative administration of olanzapine prior to knee or hip replacement surgery in high risk patients would prevent the onset of postoperative delirium.
Read the detailed description
Postoperative delirium is a serious and common (20% to 60%) complication in orthopedic surgery patients. In this study we investigate whether prophylactic administration of olanzapine can prevent delirium from occurring after knee or hip replacement in high-risk patients > 65 years of age. This is a randomized, double-blind, single center, placebo-controlled study.
- Conditions
- Delirium
- Being tested
- olanzapine, placebo
- Keywords
- delirium, atypical antipsychotics, olanzapine, orthopedic
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
olanzapineDrug
Also called Zyprexa
5 mg preoperative and 5mg postoperative prior to discharge to inpatient nursing floor
placeboDrug
placebo administered preoperatively and postoperatively prior to discharge to inpatient nursing floor
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Not described Receives: Drug: olanzapine |
| 2 | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of delirium
Measured: days in hospital
Secondary outcomes (1)
Complications, length of stay, hospital costs
Measured: days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2008 (estimated)
- Study startJan 2005
- Primary completionAug 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 495 participants (actual)
Sponsor and investigators
- Lead sponsor
- The New England Baptist Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Susan Kelly, MD, Principal investigator, New England Baptist Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00699946
- Sponsor's protocol ID
- 7381*KELLY
- Status last verified
- Jan 2009
- First submitted
- 16 Jun 2008
- Last updated
- 21 Jan 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Larsen KA, Kelly SE, Stern TA, Bode RH Jr, Price LL, Hunter DJ, Gulczynski D, Bierbaum BE, Sweeney GA, Hoikala KA, Cotter JJ, Potter AW. Administration of olanzapine to prevent postoperative delirium in elderly joint-replacement patients: a randomized, controlled trial. Psychosomatics. 2010 Sep-Oct;51(5):409-18. doi: 10.1176/appi.psy.51.5.409.
PubMed 20833940
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Placebo-Controlled Study of Perioperative Administration of Olanzapine to Prevent Postoperative Delirium in Joint Replacement Patients
- ClinicalTrials.gov ID
- NCT00699946
- Acronym / sponsor ID
- 7381*KELLY
- Conditions
- Delirium
- Keywords
- delirium, atypical antipsychotics, olanzapine, orthopedic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 495 participants (actual)
- Lead sponsor
- The New England Baptist HospitalUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Aug 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 18 Jun 2008 (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.
In this study we wanted to determine if perioperative administration of olanzapine prior to knee or hip replacement surgery in high risk patients would prevent the onset of postoperative delirium.
Detailed description
Postoperative delirium is a serious and common (20% to 60%) complication in orthopedic surgery patients. In this study we investigate whether prophylactic administration of olanzapine can prevent delirium from occurring after knee or hip replacement in high-risk patients > 65 years of age. This is a randomized, double-blind, single center, placebo-controlled study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: olanzapine |
| 2 | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- High risk for delirium age > 65 history of delirium medical comorbidities ability to give informed consent
Key exclusion criteria (1 listed)
- Dementia Alcohol abuse Current use of an antipsychotic Allergy to olanzapine
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 |
|---|---|---|
| olanzapineAlso: Zyprexa5 mg preoperative and 5mg postoperative prior to discharge to inpatient nursing floor | Drug | 1 |
| placeboplacebo administered preoperatively and postoperatively prior to discharge to inpatient nursing floor | Drug | 2 |
Primary outcome
incidence of delirium
Time frame: days in hospital
1 secondary outcome
Complications, length of stay, hospital costs
Time frame: days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2009.
- Derived from this study: PubMed 20833940Larsen KA, Kelly SE, Stern TA, Bode RH Jr, Price LL, Hunter DJ, Gulczynski D, Bierbaum BE, Sweeney GA, Hoikala KA, Cotter JJ, Potter AW. Administration of olanzapine to prevent postoperative delirium in elderly joint-replacement patients: a randomized, controlled trial. Psychosomatics. 2010 Sep-Oct;51(5):409-18. doi: 10.1176/appi.psy.51.5.409.
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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.
Susan Kelly, MD principal investigator
New England Baptist Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing olanzapine in people with Delirium, run by The New England Baptist Hospital at 1 site in United States.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 21 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
incidence of delirium (time frame: days in hospital). 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 NCT00699946, which also lists 1 linked publication.
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 21 Jan 2009.