Haloperidol Prophylaxis in Cardiac Surgery for Patients at Risk for Delirium

Phase 3

Completed

• Conditions: Postoperative Confusion
• Interventions: Drug: Placebo; Drug: Haloperidol

• Registration Number: NCT01862302
• Lead Sponsor: McMaster University

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 stopped and usual standard of care implemented by MRP.

Study Timeline

• Study First Submitted: 2013-05-09
• Study First Submitted QC: 2013-05-22
• Study First Posted: 2013-05-24
• Study Start: 2013-08
• Primary Completion: 2015-09
• Study Completion: 2016-07
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-15
• Last Update Posted: 2016-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	1 dose the night before and 1 dose the morning of surgery; OR 2 doses the morning of surgery
Haloperidol	Haloperidol	Haloperidol 1mg the night before and 1mg the morning of surgery; OR Haloperidol 2mg the morning of surgery

Primary Outcome Measures

Name	Time	Method
Feasibility of conducting a trial utilizing low dose Haloperidol use in patients post cardiac surgery	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	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

Secondary Outcome Measures

Name	Time	Method
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
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
Duration of delirium	Participants will be followed for the duration of their hospital stay to a maximum of 30 days

Trial Locations

Locations (1)

Hamilton General Site; 🇨🇦 Hamilton, Ontario, Canada