Haloperidol Prophylaxis in Cardiac Surgery for Patients at Risk for Delirium - Clinical Trial for Postoperative Confusion | NCT01862302

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Primary Purpose

Status

Completed

Phase

Phase 3

Locations

Canada

Study Type

Interventional

Intervention

Haloperidol

Placebo

About this trial

This is an interventional prevention trial for Postoperative Confusion focused on measuring Prevention delirium, Cardiac surgery

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Hamilton General Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Haloperidol

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

The incidence of delirium

Delirium severity

Total length of stay (LOS), with breakdown for intensive care unit (ICU) days and ward days

Duration of delirium

Full Information

NCT ID

NCT01862302

First Posted

May 9, 2013

Last Updated

September 15, 2016

Sponsor

McMaster University

1. Study Identification

Unique Protocol Identification Number

NCT01862302

Brief Title

Haloperidol Prophylaxis in Cardiac Surgery for Patients at Risk for Delirium

Acronym

HALPCARD

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2016

Overall Recruitment Status

Completed

Study Start Date

August 2013 (undefined)

Primary Completion Date

September 2015 (Actual)

Study Completion Date

July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

McMaster University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Postoperative Confusion

Keywords

Prevention delirium, Cardiac surgery

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

25 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Haloperidol

Arm Type

Active Comparator

Arm Description

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

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Haloperidol

Other Intervention Name(s)

Haldol

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Feasibility of conducting a trial utilizing low dose Haloperidol use in patients post cardiac surgery

Description

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

Time Frame

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

Title

Safety monitoring of low dose Haloperidol use in patients post cardiac surgery

Description

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

Time Frame