Status:
COMPLETED
Pilot Study of Haloperidol to Treat Critical Illness Delirium
Lead Sponsor:
University of Colorado, Denver
Collaborating Sponsors:
Denver Health Medical Center
Conditions:
Delirium
Critical Illness
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The goal of this study is to determine whether haloperidol reduces the time on the breathing machine in critically ill patients with delirium.
Detailed Description
Delirium is a frequent end-organ complication of critical illness and is an independent predictor of mortality in mechanically ventilated patients. However, management of delirium is a major therapeut...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2007
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00429676
Start Date
December 1 2005
End Date
September 1 2007
Last Update
November 14 2012
Active Locations (1)
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1
Denver Health Medical Center
Denver, Colorado, United States, 80204