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

Phase 3

Terminated

• Conditions: Delirium
• Interventions: Other: Saline placebo; Drug: haloperidol

• Registration Number: NCT00300391
• Lead Sponsor: University of Pittsburgh

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.

Study Timeline

• Study Start: 2006-03
• Study First Submitted: 2006-03-06
• Study First Submitted QC: 2006-03-06
• Study First Posted: 2006-03-08
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Results First Submitted: 2016-12-01
• Status Verified: 2017-11
• Results First Submitted QC: 2017-11-21
• Last Update Submitted: 2017-11-21
• Results First Posted: 2017-12-20
• Last Update Posted: 2017-12-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	Saline placebo	once diagnosed as delirious, received 5 mg saline placebo
haloperidol	haloperidol	Once diagnosed as delirious, randomized to haloperidol 5 mg IV

Primary Outcome Measures

Name	Time	Method
28-day All-cause Mortality	Daily
90-day All-cause Mortality	90 Days from enrollment in study

Secondary Outcome Measures

Name	Time	Method
ICU Length of Stay	Daily
Duration of Mechanical Ventilation	daily