Clinical Trial: Haloperidol Prophylaxis in Cardiac Surgery for Patients at Risk for Delirium

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary: 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.
Sponsor: McMaster University

Current Primary Outcome:

  • 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: McMaster University

Dates:
Date Received: May 9, 2013
Date Started: August 2013
Date Completion:
Last Updated: September 15, 2016
Last Verified: September 2016