Overview

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

Status:
Terminated

Trial end date:
2011-10-01

Target enrollment:
0

Participant gender:
All

Summary

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

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

University of Pittsburgh

Collaborator:

National Heart, Lung, and Blood Institute (NHLBI)

Treatments:

Haloperidol
Haloperidol decanoate

Criteria

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.