Haloperidol Prophylaxis in Cardiac Surgery for Patients at Risk for Delirium

Study Overview
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Brief Summary
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Will the use of prophylactic Haloperidol for patients undergoing open heart surgery reduce the incidence, duration, and severity of post cardiotomy delirium?

Detailed Description
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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.

Official Title
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Haloperidol Prophylaxis in Cardiac Surgery for Patients at Risk for Delirium: A Randomized Placebo-Controlled Pilot Study

Conditions
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Postoperative Confusion

Intervention / Treatment
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* Drug: Haloperidol
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: Parkinsonism, on any antipsychotic medications pre-op, active delirium, emergent surgery, Haloperidol allergy, schizophrenia, prolonged QTc.

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Haloperidol<br>Haloperidol 1mg the night before and 1mg the morning of surgery; OR Haloperidol 2mg the morning of surgery | Drug: Haloperidol<br>* 1mg the night before and 1mg the morning of surgery; OR Haloperidol 2mg the morning of surgery<br>* Other names: Haldol;|
| Placebo Comparator: Placebo<br>1 dose the night before and 1 dose the morning of surgery; OR 2 doses the morning of surgery | Drug: Placebo<br>* 1 dose the night before and 1 dose the morning of surgery; OR 2 doses the morning of surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | Participants will be followed for the duration of their hospital stay to a maximum of 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of delirium |  | Participants will be followed for the duration of their hospital stay to a maximum of 30 days | 
| Delirium severity |  | 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 |  | Participants will be followed for the duration of their hospital stay to a maximum of 30 days | 
| Duration of delirium |  | Participants will be followed for the duration of their hospital stay to a maximum of 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prevention delirium, Cardiac surgery