The Modifying the Impact of ICU-Associated Neurological Dysfunction-USA (MIND-USA) Study (MIND-USA)
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ClinicalTrials.gov Identifier: NCT01211522 |
Recruitment Status
:
Recruiting
First Posted
: September 29, 2010
Last Update Posted
: April 12, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Delirium Impaired Cognition Long Term Psychologic Disorders | Drug: Haloperidol Drug: Ziprasidone Drug: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 561 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | MIND-USA Study: Modifying the Impact of ICU-Associated Neurological Dysfunction |
Study Start Date : | December 2011 |
Estimated Primary Completion Date : | December 2018 |
Estimated Study Completion Date : | July 2019 |

Arm | Intervention/treatment |
---|---|
Experimental: Haloperidol
Haloperidol
|
Drug: Haloperidol
Haloperidol, up to 10mg q12 hours, will be administered intravenously (IV) by bolus over up to 5 minutes at concentrations of 5mg/mL. Patient will only receive IV while in the ICU.
Other Name: Haldol
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Experimental: Ziprasidone
Ziprasidone
|
Drug: Ziprasidone
Ziprasidone, up to 20mg q12 hours, will be administered intravenously (IV) by bolus over up to 5 minutes at concentrations of 10mg/mL. Patient will only receive IV while in the ICU.
Other Name: Geodon
|
Placebo Comparator: Placebo
Placebo
|
Drug: Placebo
Placebo, up to 10mL q12 hours, will be administered intravenously (IV) by bolus over up to 5 minutes. Patient will only receive IV while in the ICU.
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- Delirium/coma-free days [ Time Frame: 14 days ]
- Survival [ Time Frame: 30-day, 90-day, and 1-year ]
- Delirium duration [ Time Frame: 14 days ]
- ICU length of stay [ Time Frame: 1 to 90 days ]Time to ICU discharge, represented by readiness for ICU discharge indicated by a physician order for transfer to a lower level of care even if a bed availability problems prevent actual discharge from the ICU.
- Hospital length of stay [ Time Frame: 1 to 90 days ]
- Ventilator-free days [ Time Frame: 14 days ]
- ICU readmission [ Time Frame: 1 to 90 days ]
- Hospital readmission [ Time Frame: 1 to 365 days ]
- Neuropsychological dysfunction [ Time Frame: 3-month, 12-month ]Assessed using a battery of cognitive tests.
- Quality of life [ Time Frame: 3-month, 12-month ]
- Posttraumatic stress disorder [ Time Frame: 3-month, 12-month ]
- QTc prolongation [ Time Frame: 14 days ]
- Extrapyramidal symptoms [ Time Frame: 14 days ]
- Neuroleptic malignant syndrome [ Time Frame: 14 days ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- adult patients (≥18 years old)
- in a medical and/or surgical ICU
- on mechanical ventilation or non-invasive positive pressure ventilation (NIPPV), and/or requiring vasopressors due to shock
- delirious (according to the CAM-ICU)
Exclusion Criteria:
- Rapidly resolving organ failure criteria, indicated by planned immediate discontinuation of mechanical ventilation, NIPPV, and/or vasopressors at the time of screening for study enrollment
- Pregnancy or breastfeeding (negative pregnancy test required prior to enrollment of female patients of childbearing age)
- Severe dementia or neurodegenerative disease, defined as either impairment that prevents the patient from living independently at baseline or IQCODE >4.5, measured using a patient's qualified surrogate, mental illness requiring long-term institutionalization, acquired or congenital mental retardation, Parkinson's disease, Huntington's disease, and/or coma or another severe deficit due to structural brain disease such as stroke, intracranial hemorrhage, cranial trauma, intracranial malignancy, anoxic brain injury, or cerebral edema.
- History of torsades de pointes, documented baseline QT prolongation (congenital long QT syndrome), or QTc >500 ms at screening due to refractory electrolyte abnormalities, other drugs, or thyroid disease
- Ongoing maintenance therapy with typical or atypical antipsychotics
- History of neuroleptic malignant syndrome (NMS), haloperidol allergy, or ziprasidone allergy
- Expected death within 24 hours of enrollment or lack of commitment to aggressive treatment by family or the medical team (e.g., likely withdrawal of life support measures within 24 hours of screening)
- Inability to obtain informed consent from an authorized representative within 72 hours of meeting all inclusion criteria, i.e., developing qualifying organ dysfunction criteria.

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): NCT01211522
Contact: E. Wesley Ely, MD, MPH | 615-936-3395 | wes.ely@vanderbilt.edu | |
Contact: Timothy D Girard, MD, MSCI | 412-532-9779 | timothy.girard@upmc.edu |
United States, Colorado | |
Denver Health/University of Colorado Health Sciences Center | Recruiting |
Denver, Colorado, United States, 80204-4507 | |
Contact: Ivor S Douglas, MD 303-436-5905 idouglas@dhha.org | |
Principal Investigator: Ivor S Douglas, MD | |
United States, Connecticut | |
Yale University Medical Center | Recruiting |
New Haven, Connecticut, United States, 06520-8057 | |
Contact: Margaret A Pisani, MD 203-785-3627 margaret.pisani@yale.edu | |
Principal Investigator: Margaret A Pisani, MD | |
United States, Indiana | |
Indiana University | Active, not recruiting |
Indianapolis, Indiana, United States, 46202-2915 | |
United States, Iowa | |
University of Iowa | Active, not recruiting |
Iowa City, Iowa, United States, 52242 | |
United States, Maryland | |
University of Maryland Medical Center | Recruiting |
Baltimore, Maryland, United States, 21201 | |
Contact: Peter Rock, MD, MBA 410-328-8919 prock@anes.umm.edu | |
Principal Investigator: Peter Rock, MD, MBA | |
United States, Massachusetts | |
Massachusetts General Hospital | Active, not recruiting |
Boston, Massachusetts, United States, 02114-2696 | |
Brigham and Women's Hospital | Recruiting |
Boston, Massachusetts, United States, 02115 | |
Contact: Robert L Owens, MD 617-983-7489 rowens@partners.org | |
Principal Investigator: Robert L Owens, MD | |
United States, Michigan | |
University of Michigan Health System | Recruiting |
Ann Arbor, Michigan, United States, 48109-5360 | |
Contact: Robert C Hyzy, MD 734-936-5201 rhyzy@med.umich.edu | |
Principal Investigator: Robert C Hyzy, MD | |
United States, New York | |
Albert Einstein Medical College-Montefiore Medical Center | Recruiting |
Bronx, New York, United States, 10461 | |
Contact: Michelle Ng Gong, MD, MS 718-430-3712 mgong@montefiore.org | |
Principal Investigator: Michelle Ng Gong, MD, MS | |
United States, North Carolina | |
University of North Carolina - Chapel Hill | Recruiting |
Chapel Hill, North Carolina, United States, 27599-7248 | |
Contact: Shannon S Carson, MD 919-966-2531 shannon_carson@med.unc.edu | |
Principal Investigator: Shannon S Carson, MD | |
Moses Cone Health System | Recruiting |
Greensboro, North Carolina, United States, 27410 | |
Contact: Daniel J Feinstein, MD 336-832-2432 daniel.feinstein@mosescone.com | |
Principal Investigator: Daniel J Feinstein, MD | |
Wake Forest University | Withdrawn |
Winston-Salem, North Carolina, United States, 27157 | |
United States, Ohio | |
The Ohio State Medical Center | Recruiting |
Columbus, Ohio, United States, 43210-1228 | |
Contact: Matthew C. Exline, MD, MPH 614-293-4925 matthew.exline@osumc.edu | |
Principal Investigator: Matthew C. Exline, MD, MPH | |
United States, Pennsylvania | |
University of Pennsylvania | Active, not recruiting |
Philadelphia, Pennsylvania, United States, 19104-6205 | |
United States, Tennessee | |
Vanderbilt University Medical Center | Recruiting |
Nashville, Tennessee, United States, 37232-8300 | |
Contact: Wes E. Ely, MD, MPH 615-936-3702 wes.ely@vanderbilt.edu | |
Contact: Tim Girard, MD, MPH 1-412-532-9779 timothy.girard@upmc.edu | |
United States, Texas | |
Baylor Health Care System | Active, not recruiting |
Dallas, Texas, United States, 75206 | |
United States, Washington | |
University of Washington | Recruiting |
Seattle, Washington, United States, 98195-9472 | |
Contact: Catherine Hough, MD 206-744-3356 cterrlee@uw.edu | |
Principal Investigator: Catherine Hough, MD |
Principal Investigator: | E. Wesley Ely, MD, MPH | Vanderbilt University Medical Center |
Responsible Party: | Wes Ely, Professor of Medicine, Vanderbilt University |
ClinicalTrials.gov Identifier: | NCT01211522 History of Changes |
Other Study ID Numbers: |
AG035117-01A1 101082 ( Other Identifier: Vanderbilt University Institutional Review Board ) |
First Posted: | September 29, 2010 Key Record Dates |
Last Update Posted: | April 12, 2018 |
Last Verified: | April 2018 |
Keywords provided by Wes Ely, Vanderbilt University:
Delirium Intensive care Mechanical ventilation Antipsychotic Haloperidol Ziprasidone |
Randomized Placebo Sepsis Sedation Long-term cognitive impairment |
Additional relevant MeSH terms:
Delirium Cognitive Dysfunction Confusion Neurobehavioral Manifestations Neurologic Manifestations Nervous System Diseases Signs and Symptoms Neurocognitive Disorders Mental Disorders Cognition Disorders Haloperidol Haloperidol decanoate Ziprasidone Antiemetics 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 Serotonin Antagonists Serotonin Agents |