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Sponsors and Collaborators: |
University of Pittsburgh National Heart, Lung, and Blood Institute (NHLBI) |
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Information provided by: | University of Pittsburgh |
ClinicalTrials.gov Identifier: | NCT00300391 |
The purpose of this study is to determine if treating delirious intensive care unit patients with haloperidol improves mortality.
Condition | Intervention | Phase |
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Delirium |
Drug: haloperidol |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | ORIC-I: Optimizing Recovery From Intensive Care: Mechanical Ventilation and Delirium |
Estimated Enrollment: | 304 |
Study Start Date: | March 2006 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
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:
Exclusion Criteria:
Contact: Barbara J Early, BSN | 412 647 9745 | earlybj@upmc.edu |
Contact: Tina M Vita, RN | 412 647 9652 | vitatm@upmc.edu |
United States, Pennsylvania | |
Presbyterian, UPMC | Recruiting |
Pittsburgh, Pennsylvania, United States, 15261 |
Principal Investigator: | Eric B Milbrandt, MD, MPH | University of Pittsburgh |
Responsible Party: | University of Pittsburgh ,Department of Critical Care ( Eric B. Milbrant, MD,MPH ) |
Study ID Numbers: | 0505051, NHLBI, 1 K23 HL078760-01A1 |
Study First Received: | March 6, 2006 |
Last Updated: | October 13, 2008 |
ClinicalTrials.gov Identifier: | NCT00300391 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Delirium Mechanical ventilation Intensive care Haloperidol |
Neurotransmitter Agents Tranquilizing Agents Psychotropic Drugs Central Nervous System Depressants Antiemetics Confusion Antipsychotic Agents Cognition Disorders Haloperidol Signs and Symptoms |
Haloperidol decanoate Dopamine Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Neurologic Manifestations Dopamine Agents Peripheral Nervous System Agents Dementia Neurobehavioral Manifestations Delirium |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Physiological Effects of Drugs Psychotropic Drugs Antiemetics Haloperidol Signs and Symptoms Mental Disorders Therapeutic Uses Neurobehavioral Manifestations Delirium Tranquilizing Agents Nervous System Diseases |
Gastrointestinal Agents Central Nervous System Depressants Confusion Dopamine Antagonists Antipsychotic Agents Pharmacologic Actions Haloperidol decanoate Delirium, Dementia, Amnestic, Cognitive Disorders Autonomic Agents Neurologic Manifestations Dopamine Agents Peripheral Nervous System Agents Central Nervous System Agents |