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Completed

NCT Number: NCT01862302

Haloperidol Prophylaxis in Cardiac Surgery for Patients at Risk for Delirium

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

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Key information

Conditions

Postoperative Confusion

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hamilton General Site

Hamilton, Ontario, L8L 2X2, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Haloperidol

Drug

1mg the night before and 1mg the morning of surgery; OR Haloperidol 2mg the morning of surgery

Other names: Haldol

Placebo

Drug

1 dose the night before and 1 dose the morning of surgery; OR 2 doses the morning of surgery

Primary outcomes

  1. 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

  2. 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 outcomes

  1. The incidence of delirium

    Time frame: Participants will be followed for the duration of their hospital stay to a maximum of 30 days

  2. Delirium severity

    Time frame: Participants will be followed for the duration of their hospital stay to a maximum of 30 days

  3. 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

  4. Duration of delirium

    Time frame: Participants will be followed for the duration of their hospital stay to a maximum of 30 days

Other outcomes

  1. An economic analysis will be completed to determine if Haloperidol prophylaxis resulted in any cost savings

    Time frame: Participants will be followed for the duration of their hospital stay to a maximum of 30 days

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Registry information

Official study title

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

Acronym: HALPCARD

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
May 24, 2013
Registry last updated
Sep 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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