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

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ClinicalTrials.gov Identifier: NCT00300391
Recruitment Status : Terminated (Insufficient recruitment to meet aims.)
First Posted : March 8, 2006
Results First Posted : December 20, 2017
Last Update Posted : December 20, 2017
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Barb Early, University of Pittsburgh

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

Condition or disease Intervention/treatment Phase
Delirium Drug: haloperidol Other: Saline placebo Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: ORIC-I: Optimizing Recovery From Intensive Care: Mechanical Ventilation and Delirium
Study Start Date : March 2006
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 28-day All-cause Mortality [ Time Frame: Daily ]
  2. 90-day All-cause Mortality [ Time Frame: 90 Days from enrollment in study ]

Secondary Outcome Measures :
  1. Duration of Mechanical Ventilation [ Time Frame: daily ]
  2. ICU Length of Stay [ Time Frame: Daily ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00300391

Sponsors and Collaborators
University of Pittsburgh
National Heart, Lung, and Blood Institute (NHLBI)
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Principal Investigator: Eric B Milbrandt, MD, MPH University of Pittsburgh Medical Center
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Responsible Party: Barb Early, MACRO Clinical Director, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00300391    
Other Study ID Numbers: 0505051
1K23HL078760-01A1 ( U.S. NIH Grant/Contract )
First Posted: March 8, 2006    Key Record Dates
Results First Posted: December 20, 2017
Last Update Posted: December 20, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Barb Early, University of Pittsburgh:
Mechanical ventilation
Intensive care
Additional relevant MeSH terms:
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Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Haloperidol decanoate
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents