Haloperidol Prophylaxis in Cardiac Surgery for Patients at Risk for Delirium

Condition(s) targeted: Postoperative Confusion

Intervention: Haloperidol (Drug); Placebo (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: McMaster University

Official(s) and/or principal investigator(s):
Andre Lamy, MD, Principal Investigator, Affiliation: McMaster University

Overall contact:
Andre Lamy, MD, Phone: 905-527-4322, Ext: 40325, Email: lamyand@hhsc.ca

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

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

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

Primary outcome:

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

Safety monitoring of low dose Haloperidol use in patients post cardiac surgery

Secondary outcome:

The incidence of delirium

Delirium severity

Total length of stay (LOS), with breakdown for intensive care unit (ICU) days and ward days

Duration of 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.

Minimum age: 60 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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.

Andre Lamy, MD, Phone: 905-527-4322, Ext: 40325, Email: lamyand@hhsc.ca

Hamilton General Site, Hamilton, Ontario L8L 2X2, Canada; Recruiting
Andre Lamy, MD, Phone: 905-527-4322, Ext: 40325, Email: lamyand@hhsc.ca
Andre Lamy, MD, Principal Investigator

Starting date: August 2013
Last updated: March 30, 2015