Conditions: Delirium
Keywords: Delirium Mechanical ventilation Intensive care Haloperidol
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 40
Healthy volunteers: no

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

Arms:
arm 1: Once diagnosed as delirious, randomized to haloperidol 5 mg IV arm 2: once diagnosed as delirious, received 5 mg saline placebo

Interventions: intervention 1: haloperidol intervention 2: Saline placebo
Intervention descriptions: intervention 1: Aim #1. To conduct a RCT of IV haloperidol vs. placebo for the treatment of delirium in mechanically ventilated ICU patients. Patients in the cohort study that go on to develop delirium will be enrolled in a RCT comparing treatment with scheduled haloperidol vs. placebo. By comparing differences between treatment and placebo groups, we will test the hypothesis that treatment with scheduled haloperidol improves the primary outcome of 28-day and 90 day mortality and secondary outcomes of total delirium days, duration of mechanical ventilation, and ICU length of stay. intervention 2: control arem

Protocol document: