Trial record 14 of 326 for:
Open Studies | "Intensive Care"
ORIC-I: Optimizing Recovery From Intensive Care: Mechanical Ventilation and Delirium
The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by University of Pittsburgh.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
University of Pittsburgh
Collaborator:
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00300391
First received: March 6, 2006
Last updated: October 13, 2008
Last verified: October 2008
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Purpose
The purpose of this study is to determine if treating delirious intensive care unit patients with haloperidol improves mortality.
| Condition | Intervention | Phase |
|---|---|---|
|
Delirium |
Drug: haloperidol |
Phase 2 |
| 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 ]
| 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) |
Intervention Details:
Detailed Description:
-
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.
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00300391
Contacts
| Contact: Barbara J Early, BSN | 412 647 9745 | earlybj@upmc.edu |
| Contact: Tina M Vita, RN | 412 647 9652 | vitatm@upmc.edu |
Locations
| United States, Pennsylvania | |
| Presbyterian, UPMC | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15261 | |
Sponsors and Collaborators
University of Pittsburgh
Investigators
| Principal Investigator: | Eric B Milbrandt, MD, MPH | University of Pittsburgh |
More Information
Publications:
| Responsible Party: | Eric B. Milbrant, MD,MPH, University of Pittsburgh ,Department of Critical Care |
| ClinicalTrials.gov Identifier: | NCT00300391 History of Changes |
| Other Study ID Numbers: | 0505051, NHLBI, 1 K23 HL078760-01A1 |
| Study First Received: | March 6, 2006 |
| Last Updated: | October 13, 2008 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of Pittsburgh:
|
Delirium Mechanical ventilation Intensive care Haloperidol |
Additional relevant MeSH terms:
|
Delirium Confusion Neurobehavioral Manifestations Neurologic Manifestations Nervous System Diseases Signs and Symptoms Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Haloperidol Haloperidol decanoate Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
Pharmacologic Actions Central Nervous System Agents Therapeutic Uses 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 |
ClinicalTrials.gov processed this record on May 23, 2013