Postoperative ConfusionPhase 3HALPCARDNCT01862302
Haloperidol Prophylaxis in Cardiac Surgery for Patients at Risk for Delirium
A Phase 3 study testing Haloperidol in people with Postoperative Confusion, run by McMaster University at 1 site in Canada.
Trial summary
Will the use of prophylactic Haloperidol for patients undergoing open heart surgery reduce the incidence, duration, and severity of post cardiotomy delirium? Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Postoperative Confusion
- What is being tested?
- Haloperidol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2013to Jul 2016
- Phase
- Phase 3
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Greater than or equal to 70 years of age, undergoing a median sternotomy OR 60-69yrs of age with one or more of the risk factors:
- TIA/Stroke;
- Euroscore greater than or equal to 5;
- abnormal clock draw.
Who cannot join
- Parkinsonism,
- on any antipsychotic medications pre-op,
- active delirium,
- emergent surgery,
- Haloperidol allergy,
- schizophrenia,
- prolonged QTc.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Haloperidol Prophylaxis in Cardiac Surgery for Patients at Risk for Delirium: A Randomized Placebo-Controlled Pilot Study
Will the use of prophylactic Haloperidol for patients undergoing open heart surgery reduce the incidence, duration, and severity of post cardiotomy delirium?
Read the detailed description
Pilot study for feasibility and safety, n = 40, haloperidol 1mg vs. placebo BID administered night before and day of surgery, then continued for total 72hrs post-op, if delirium occurs study drug is stopped and usual standard of care implemented by MRP.
- Conditions
- Postoperative Confusion
- Being tested
- Haloperidol, Placebo
- Keywords
- Prevention delirium, Cardiac surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HaloperidolDrug
Also called Haldol
1mg the night before and 1mg the morning of surgery; OR Haloperidol 2mg the morning of surgery
PlaceboDrug
1 dose the night before and 1 dose the morning of surgery; OR 2 doses the morning of surgery
| Study group | Role | What they receive |
|---|---|---|
| Haloperidol | Active comparator | Haloperidol 1mg the night before and 1mg the morning of surgery; OR Haloperidol 2mg the morning of surgery Receives: Drug: Haloperidol |
| Placebo | Placebo comparator | 1 dose the night before and 1 dose the morning of surgery; OR 2 doses the morning of surgery Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of conducting a trial utilizing low dose Haloperidol use in patients post cardiac surgery
If a participant does not develop delirium post operatively, then the confusion assessment method (CAM)will be monitored for 24 hours after the study medication ends. Patients will be followed up until seven days or until discharge if no delirium occurs, or if delirium is detected, up to 30 days or until discharge
Measured: Participants will be followed for the duration of their hospital stay to a maximum of 30 days.
Safety monitoring of low dose Haloperidol use in patients post cardiac surgery
If a participant does not develop delirium post operatively, then the confusion assessment method (CAM)will be monitored for 24 hours after the study medication ends. Patients will be followed up until seven days or until discharge if no delirium occurs, or if delirium is detected, up to 30 days or until discharge
Measured: Participants will be followed for the duration of their hospital stay to a maximum of 30 days
Secondary outcomes (4)
The incidence of delirium
Measured: Participants will be followed for the duration of their hospital stay to a maximum of 30 days
Delirium severity
Measured: Participants will be followed for the duration of their hospital stay to a maximum of 30 days
Total length of stay (LOS), with breakdown for intensive care unit (ICU) days and ward days
Measured: Participants will be followed for the duration of their hospital stay to a maximum of 30 days
Duration of delirium
Measured: Participants will be followed for the duration of their hospital stay to a maximum of 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2013 (estimated)
- Study startAug 2013
- Primary completionSep 2015
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative ConfusionStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andre Lamy, McMaster University
- Investigators
- Andre Lamy, MD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01862302
- Sponsor's protocol ID
- HALPCARD-2013
- Acronym
- HALPCARD
- Status last verified
- Sep 2016
- First submitted
- 9 May 2013
- Last updated
- 16 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Haloperidol Prophylaxis in Cardiac Surgery for Patients at Risk for Delirium: A Randomized Placebo-Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT01862302
- Acronym / sponsor ID
- HALPCARD / HALPCARD-2013
- Conditions
- Postoperative Confusion
- Keywords
- Prevention delirium, Cardiac surgery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Sep 2015 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 24 May 2013 (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.
Will the use of prophylactic Haloperidol for patients undergoing open heart surgery reduce the incidence, duration, and severity of post cardiotomy delirium?
Detailed description
Pilot study for feasibility and safety, n = 40, haloperidol 1mg vs. placebo BID administered night before and day of surgery, then continued for total 72hrs post-op, if delirium occurs study drug is stopped and usual standard of care implemented by MRP.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Haloperidol | Active comparator | Drug: HaloperidolHaloperidol 1mg the night before and 1mg the morning of surgery; OR Haloperidol 2mg the morning of surgery |
| Placebo | Placebo comparator | Drug: Placebo1 dose the night before and 1 dose the morning of surgery; OR 2 doses the morning of surgery |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Greater than or equal to 70 years of age, undergoing a median sternotomy OR 60-69yrs of age with one or more of the risk factors:
Key exclusion criteria (7 listed)
- Parkinsonism,
- on any antipsychotic medications pre-op,
- active delirium,
- emergent surgery,
- Haloperidol allergy,
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: Haldol1mg the night before and 1mg the morning of surgery; OR Haloperidol 2mg the morning of surgery | Drug | Haloperidol |
| Placebo1 dose the night before and 1 dose the morning of surgery; OR 2 doses the morning of surgery | Drug | Placebo |
Primary outcome
Feasibility of conducting a trial utilizing low dose Haloperidol use in patients post cardiac surgery
Time frame: Participants will be followed for the duration of their hospital stay to a maximum of 30 days.
If a participant does not develop delirium post operatively, then the confusion assessment method (CAM)will be monitored for 24 hours after the study medication ends. Patients will be followed up until seven days or until discharge if no delirium occurs, or if delirium is detected, up to 30 days or until discharge
Safety monitoring of low dose Haloperidol use in patients post cardiac surgery
Time frame: Participants will be followed for the duration of their hospital stay to a maximum of 30 days
If a participant does not develop delirium post operatively, then the confusion assessment method (CAM)will be monitored for 24 hours after the study medication ends. Patients will be followed up until seven days or until discharge if no delirium occurs, or if delirium is detected, up to 30 days or until discharge
4 secondary outcomes
The incidence of delirium
Time frame: Participants will be followed for the duration of their hospital stay to a maximum of 30 days
Delirium severity
Time frame: Participants will be followed for the duration of their hospital stay to a maximum of 30 days
Total length of stay (LOS), with breakdown for intensive care unit (ICU) days and ward days
Time frame: Participants will be followed for the duration of their hospital stay to a maximum of 30 days
Duration of delirium
Time frame: Participants will be followed for the duration of their hospital stay to a maximum of 30 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 16 Sep 2016.
Related trials for Postoperative Confusion
RecruitingObservational study
The Impact of Fast-Track Anesthesia on Postoperative Neurocognitive Function in Patients Undergoing Cardiac Surgery
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Prediction and Prevention of Postoperative Mortality and Morbidity
Dementia, Postoperative Delirium (POD)
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The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
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Lactium Premedication to Prevent Emergence Agitation
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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.
Andre Lamy, MD principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Haloperidol in people with Postoperative Confusion, run by McMaster University at 1 site 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 4 inclusion and 7 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 16 Sep 2016. 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 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. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Feasibility of conducting a trial utilizing low dose Haloperidol use in patients post cardiac surgery (time frame: Participants will be followed for the duration of their hospital stay to a maximum of 30 days.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Sep 2016.