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

McMaster University

Status and phase: Completed; Phase 3

Conditions: Postoperative Confusion

Treatments: Drug: Haloperidol; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01862302

HALPCARD-2013

Details and patient eligibility

About

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

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 60+ years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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25 participants in 2 patient groups, including a placebo group

Haloperidol

Active Comparator group

Description:

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

Treatment:

Drug: Haloperidol

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo