Status:
TERMINATED
ORIC-I: Optimizing Recovery From Intensive Care: Mechanical Ventilation and Delirium
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Delirium
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine if treating delirious intensive care unit patients with haloperidol improves mortality.
Detailed Description
Intensive care unit delirium is a serious medical condition that is associated with increased morbidity and mortality. In this study, 304 delirious mechanically ventilated subjects will be randomized ...
Eligibility Criteria
Inclusion
- All adult (\>=18 years of age) mechanically ventilated patients admitted to the medical, surgical, trauma, or cardiothoracic ICUs of the UPMC main campus who are expected by the ICU clinical team to require \>24 hours of mechanical ventilation
Exclusion
- Baseline QTc \>480 milliseconds (ms); history of Parkinson's disease; pregnancy; history of schizophrenia or neurologic disease that would confound the delirium assessment; deafness or inability to understand English or Spanish; extubation prior to enrollment; previously enrolled in this study; patient, family, or attending physician refusal; death before enrollment; treatment with haloperidol within 2 days prior to ICU admission; and prisoners.
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00300391
Start Date
March 1 2006
End Date
October 1 2011
Last Update
December 20 2017
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