Pilot Study of Haloperidol to Treat Critical Illness Delirium

• Status: Completed
• Trial end date: 2007-09-01
• Target enrollment: 0
• Participant gender: All

Summary

The goal of this study is to determine whether haloperidol reduces the time on the breathing machine in critically ill patients with delirium.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Colorado, Denver
• Collaborator: Denver Health Medical Center
• Treatments: Haloperidol; Haloperidol decanoate

Criteria

Inclusion Criteria:

• Mechanically ventilated within 24 hours of arrival to the ICU

• Delirium as assessed by CAM-ICU within 24 hours of arrival to the ICU

• Age > 18

Exclusion Criteria:

• Known allergy to haloperidol or other neuroleptics

• Neurological injury or trauma

• < 24 hours after a major operation

• History of Axis I psychiatric disorder or significant dementia

• Baseline QTc of > 500 msec or a pacemaker which makes the QTc uninterpretable

• History of seizure disorder

• Morbid obesity (> 1kg/cm body weight)

• Hepatic failure (Child's Class C)

• Neuromuscular disease (C5 or higher spinal cord injury, ALS, Guillain-Barre Syndrome, and myasthenia gravis)

• Malignancy or other irreversible disease or condition for which 6 month mortality is estimated to be ≥ 50%

• Pregnancy (negative pregnancy test required for women of child-bearing potential)