ORIC-I: Optimizing Recovery From Intensive Care: Mechanical Ventilation and Delirium

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 to haloperidol 5mg IV every 12 hours or placebo to determine if
treatment with haloperidol improves short and long-term mortality.

Inclusion Criteria:

- 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 Criteria:

- 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.