Status:
COMPLETED
Haloperidol Prophylaxis in Cardiac Surgery for Patients at Risk for Delirium
Lead Sponsor:
McMaster University
Conditions:
Postoperative Confusion
Eligibility:
All Genders
60+ years
Phase:
PHASE3
Brief Summary
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 s...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Parkinsonism,
- on any antipsychotic medications pre-op,
- active delirium,
- emergent surgery,
- Haloperidol allergy,
- schizophrenia,
- prolonged QTc.
Key Trial Info
Start Date :
August 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2016
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT01862302
Start Date
August 1 2013
End Date
July 1 2016
Last Update
September 16 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hamilton General Site
Hamilton, Ontario, Canada, L8L 2X2