Insufficient recruitment to meet aims.

The purpose of this study is to determine if treating delirious intensive care unit patients with haloperidol improves mortality.

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.

Limited data can be obtained to make sure AE data time frame. However, once the patient has left the ICU, data will no longer collect on a daily basis. On or about day 28 after enrollment and 90-days after enrollment, a research coordinator will contact the patient. For this 28-day and 90-day follow-up, the following were recorded 1) whether the patient is in the hospital and if not, where the patient was discharged to, and 2) if the patient is alive and if not, what the cause of death was.

All the AEs were reported as the relationship to study drug. The following four cases were reported as very likely related to study drug. AEs were not reported as "Serious" or not in the limited data we found. All the AEs were listed in one table, and only Elevated QTc 494, 505, 548, 520 are very likely related to study drug, and the others are not related to study drug.

This study was pre-maturely terminated. Although sincere efforts were made to locate the relevant and accurate data, limited data could be obtained. Also, conflicting information was available with respect to participant enrollment.