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

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

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.

Intervention(s) in this Clinical Trial

• Drug: haloperidol
  • 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.

Primary Measures

• 28-day all-cause mortality
  • Time Frame: Daily
    Safety Issue?: Yes
• 90-day all-cause mortality
  • Time Frame: 90 Days from enrollment in study
    Safety Issue?: Yes

Secondary Measures

• Total delirium days
  • Time Frame: Daily
    Safety Issue?: Yes
• Duration of mechanical ventilation
  • Time Frame: daily
    Safety Issue?: Yes
• ICU length of stay
  • Time Frame: Daily
    Safety Issue?: Yes

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: University of Pittsburgh Other

Overall Clinical Trial Officials and Contacts

Eric B Milbrandt, MD, MPH Principal Investigator University of Pittsburgh  

Overall Contact: Barbara J Early, BSN 412 647 9745 earlybj@upmc.edu

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00300391

Study ID Number: 0505051

ClinicalTrials.gov Identifier: NCT00300391

Health Authority: United States: Food and Drug Administration