Pilot Study of Haloperidol to Treat Critical Illness Delirium

Completed · Phase 2

Conditions studied: Delirium, Critical Illness

In brief

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

Key facts

Study ID

NCT00429676

Run by

University of Colorado, Denver

People needed

20

Starts

2005-12-01

Expected to finish

2007-09-01

Last updated by the study team

2012-11-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• Denver Health Medical Center — Denver, Colorado, United States

Full record on ClinicalTrials.gov

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