Haloperidol Prophylaxis in Cardiac Surgery for Patients at Risk for Delirium

NCT ID: NCT01862302

Last Updated: 2016-09-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2016-07-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Postoperative Confusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Haloperidol

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

Group Type ACTIVE_COMPARATOR

Haloperidol

Intervention Type DRUG

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

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Haloperidol

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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Haldol

Eligibility Criteria

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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.
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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McMaster University

OTHER

Sponsor Role lead

Responsible Party

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Andre Lamy

Dr Andre Lamy, MD, FRCSC, MHSc, Cardiac Surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andre Lamy, MD

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Locations

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Hamilton General Site

Hamilton, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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HALPCARD-2013

Identifier Type: -

Identifier Source: org_study_id

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