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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01862302
Recruitment Status : Completed
First Posted : May 24, 2013
Last Update Posted : September 16, 2016
Sponsor:
Information provided by (Responsible Party):
Andre Lamy, McMaster University

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

Condition or disease Intervention/treatment Phase
Postoperative Confusion Drug: Haloperidol Drug: Placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Haloperidol Prophylaxis in Cardiac Surgery for Patients at Risk for Delirium: A Randomized Placebo-Controlled Pilot Study
Study Start Date : August 2013
Actual Primary Completion Date : September 2015
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine


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 Name: 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




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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 ]


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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01862302


Locations
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Canada, Ontario
Hamilton General Site
Hamilton, Ontario, Canada, L8L 2X2
Sponsors and Collaborators
McMaster University
Investigators
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Principal Investigator: Andre Lamy, MD McMaster University
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Responsible Party: Andre Lamy, Dr Andre Lamy, MD, FRCSC, MHSc, Cardiac Surgeon, McMaster University
ClinicalTrials.gov Identifier: NCT01862302    
Other Study ID Numbers: HALPCARD-2013
First Posted: May 24, 2013    Key Record Dates
Last Update Posted: September 16, 2016
Last Verified: September 2016
Keywords provided by Andre Lamy, McMaster University:
Prevention delirium
Cardiac surgery
Additional relevant MeSH terms:
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Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Haloperidol
Haloperidol decanoate
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents