Haloperidol Prophylaxis in Cardiac Surgery for Patients at Risk for Delirium

Postoperative Confusion Clinical Trial

— HALPCARD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01862302
• Other study ID #: HALPCARD-2013
• Status: Completed
• Phase: Phase 3
• First received: May 9, 2013
• Last updated: September 15, 2016
• Start date: August 2013
• Est. completion date: July 2016

Study information

• Verified date: September 2016
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: July 2016
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 60 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Confusion
• Delirium
• Postoperative Confusion

Intervention

Drug:
• Haloperidol
1mg the night before and 1mg the morning of surgery; OR Haloperidol 2mg the morning of surgery
• Placebo
1 dose the night before and 1 dose the morning of surgery; OR 2 doses the morning of surgery

Locations

Country	Name	City	State
Canada	Hamilton General Site	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
McMaster University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	An economic analysis will be completed to determine if Haloperidol prophylaxis resulted in any cost savings		Participants will be followed for the duration of their hospital stay to a maximum of 30 days	No
Primary	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.	No
Primary	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	Yes
Secondary	The incidence of delirium		Participants will be followed for the duration of their hospital stay to a maximum of 30 days	No
Secondary	Delirium severity		Participants will be followed for the duration of their hospital stay to a maximum of 30 days	No
Secondary	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	No
Secondary	Duration of delirium		Participants will be followed for the duration of their hospital stay to a maximum of 30 days	No