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

Condition(s) targeted: Delirium

Intervention: haloperidol (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: University of Pittsburgh

Official(s) and/or principal investigator(s):
Eric B Milbrandt, MD, MPH, Principal Investigator, Affiliation: University of Pittsburgh

Overall contact:
Barbara J Early, BSN, Phone: 412 647 9745, Email: earlybj@upmc.edu

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

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome:

28-day all-cause mortality

90-day all-cause mortality

Secondary outcome:

Total delirium days

Duration of mechanical ventilation

ICU length of stay

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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.

Barbara J Early, BSN, Phone: 412 647 9745, Email: earlybj@upmc.edu

Presbyterian, UPMC, Pittsburgh, Pennsylvania 15261, United States; Recruiting

Related publications:

Milbrandt EB, Kersten A, Kong L, Weissfeld LA, Clermont G, Fink MP, Angus DC. Haloperidol use is associated with lower hospital mortality in mechanically ventilated patients. Crit Care Med. 2005 Jan;33(1):226-9; discussion 263-5.

Starting date: March 2006
Last updated: October 13, 2008