NCT01862302

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Aug 2013

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 9, 2013

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 24, 2013

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2013

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

September 16, 2016

Status Verified

September 1, 2016

Enrollment Period

2.1 years

First QC Date

May 9, 2013

Last Update Submit

September 15, 2016

Conditions

Postoperative Confusion

Keywords

Prevention deliriumCardiac surgery

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • 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 Outcomes (1)

  • 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

Study Arms (2)

Haloperidol

ACTIVE COMPARATOR

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

Drug: Haloperidol

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

HaloperidolDRUG

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

Also known as: Haldol
Haloperidol
PlaceboDRUG

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

Placebo

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Parkinsonism,
  • on any antipsychotic medications pre-op,
  • active delirium,
  • emergent surgery,
  • Haloperidol allergy,
  • schizophrenia,
  • prolonged QTc.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hamilton General Site

Hamilton, Ontario, L8L 2X2, Canada

Location

MeSH Terms

Interventions

Haloperidol

Intervention Hierarchy (Ancestors)

ButyrophenonesKetonesOrganic Chemicals

Study Officials

  • Andre Lamy, MD

    McMaster University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Andre Lamy, MD, FRCSC, MHSc, Cardiac Surgeon

Study Record Dates

First Submitted

May 9, 2013

First Posted

May 24, 2013

Study Start

August 1, 2013

Primary Completion

September 1, 2015

Study Completion

July 1, 2016

Last Updated

September 16, 2016

Record last verified: 2016-09

Locations

CA(1)