Haloperidol Prophylaxis in Cardiac Surgery for Patients at Risk for Delirium

Overview

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

Full Title of Study: “Haloperidol Prophylaxis in Cardiac Surgery for Patients at Risk for Delirium: A Randomized Placebo-Controlled Pilot Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: September 2015

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.

Interventions

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

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • Feasibility of conducting a trial utilizing low dose Haloperidol use in patients post cardiac surgery
    • Time Frame: 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
    • Time Frame: 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 Measures

  • The incidence of delirium
    • Time Frame: Participants will be followed for the duration of their hospital stay to a maximum of 30 days
  • Delirium severity
    • Time Frame: 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
    • Time Frame: Participants will be followed for the duration of their hospital stay to a maximum of 30 days
  • Duration of delirium
    • Time Frame: Participants will be followed for the duration of their hospital stay to a maximum of 30 days

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 60 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • McMaster University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Andre Lamy, Dr Andre Lamy, MD, FRCSC, MHSc, Cardiac Surgeon – McMaster University
  • Overall Official(s)
    • Andre Lamy, MD, Principal Investigator, McMaster University

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