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

This study has been terminated.
(Insufficient recruitment to meet aims.)
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Barb Early, University of Pittsburgh
ClinicalTrials.gov Identifier:
First received: March 6, 2006
Last updated: May 10, 2016
Last verified: May 2016
The purpose of this study is to determine if treating delirious intensive care unit patients with haloperidol improves mortality.

Condition Intervention Phase
Drug: haloperidol
Other: Saline placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: ORIC-I: Optimizing Recovery From Intensive Care: Mechanical Ventilation and Delirium

Resource links provided by NLM:

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • 28-day all-cause mortality [ Time Frame: Daily ] [ Designated as safety issue: Yes ]
  • 90-day all-cause mortality [ Time Frame: 90 Days from enrollment in study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Total delirium days [ Time Frame: Daily ] [ Designated as safety issue: Yes ]
  • Duration of mechanical ventilation [ Time Frame: daily ] [ Designated as safety issue: Yes ]
  • ICU length of stay [ Time Frame: Daily ] [ Designated as safety issue: Yes ]

Enrollment: 40
Study Start Date: March 2006
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: haloperidol
Once diagnosed as delirious, randomized to haloperidol 5 mg IV
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.
Other Name: Haldol
Placebo Comparator: placebo
once diagnosed as delirious, received 5 mg saline placebo
Other: Saline placebo
control arem

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.

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00300391

Sponsors and Collaborators
University of Pittsburgh
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Eric B Milbrandt, MD, MPH University of Pittsburgh
  More Information

Responsible Party: Barb Early, MACRO Clinical Director, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00300391     History of Changes
Other Study ID Numbers: 0505051  1K23HL078760-01A1 
Study First Received: March 6, 2006
Last Updated: May 10, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Pittsburgh:
Mechanical ventilation
Intensive care

Additional relevant MeSH terms:
Mental Disorders
Nervous System Diseases
Neurobehavioral Manifestations
Neurocognitive Disorders
Neurologic Manifestations
Signs and Symptoms
Haloperidol decanoate
Anti-Dyskinesia Agents
Antipsychotic Agents
Autonomic Agents
Central Nervous System Depressants
Dopamine Agents
Dopamine Antagonists
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Psychotropic Drugs
Tranquilizing Agents

ClinicalTrials.gov processed this record on May 23, 2016