Haloperidol Prophylaxis in Cardiac Surgery for Patients at Risk for Delirium (HALPCARD)

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

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

Study Overview

• Status: Completed
• Conditions: Postoperative Confusion
• Intervention / Treatment: Drug: Haloperidol; Drug: Placebo

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 Type: Interventional
• Enrollment (Actual): 25
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8L 2X2
      • Hamilton General Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Haloperidol; Haloperidol 1mg the night before and 1mg the morning of surgery; OR Haloperidol 2mg the morning of surgery	Drug: Haloperidol; 1mg the night before and 1mg the morning of surgery; OR Haloperidol 2mg the morning of surgery; Other Names: Haldol
PLACEBO_COMPARATOR: Placebo; 1 dose the night before and 1 dose the morning of surgery; OR 2 doses 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of conducting a trial utilizing low dose Haloperidol use in patients post cardiac surgery	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	Participants will be followed for the duration of their hospital stay to a maximum of 30 days.
Safety monitoring of low dose Haloperidol use in patients post cardiac surgery	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	Participants will be followed for the duration of their hospital stay to a maximum of 30 days

Secondary Outcome Measures

Outcome Measure	Time Frame
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
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
Duration of delirium	Participants will be followed for the duration of their hospital stay to a maximum of 30 days

Other Outcome Measures

Outcome Measure	Time Frame
An economic analysis will be completed to determine if Haloperidol prophylaxis resulted in any cost savings	Participants will be followed for the duration of their hospital stay to a maximum of 30 days

Collaborators and Investigators

• Sponsor: McMaster University

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (ACTUAL): September 1, 2015
• Study Completion (ACTUAL): July 1, 2016

Study Registration Dates

• First Submitted: May 9, 2013
• First Submitted That Met QC Criteria: May 22, 2013
• First Posted (ESTIMATE): May 24, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): September 16, 2016
• Last Update Submitted That Met QC Criteria: September 15, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: Cardiac surgery; Prevention delirium
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Confusion; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Dopamine Agents; Dopamine Antagonists; Anti-Dyskinesia Agents; Haloperidol; Haloperidol decanoate
• Other Study ID Numbers: HALPCARD-2013