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

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

Detailed Description
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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.

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

Conditions
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Delirium

Intervention / Treatment
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* Drug: haloperidol
* Other: Saline placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: haloperidol<br>Once diagnosed as delirious, randomized to haloperidol 5 mg IV | Drug: haloperidol<br>* 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.<br>* Other names: Haldol;|
| Placebo Comparator: placebo<br>once diagnosed as delirious, received 5 mg saline placebo | Other: Saline placebo<br>* control arem<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 28-day All-cause Mortality |  | Daily | 
| 90-day All-cause Mortality |  | 90 Days from enrollment in study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Mechanical Ventilation |  | daily | 
| ICU Length of Stay |  | Daily | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Delirium, Mechanical ventilation, Intensive care, Haloperidol