The Modifying the Impact of ICU-Associated Neurological Dysfunction-USA (MIND-USA) Study (MIND-USA)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01211522 |
Recruitment Status :
Completed
First Posted : September 29, 2010
Results First Posted : August 20, 2019
Last Update Posted : November 18, 2019
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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) |
Actual Enrollment : | 566 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Masking Description: | Double blind, placebo controlled |
Primary Purpose: | Treatment |
Official Title: | MIND-USA Study: Modifying the Impact of ICU-Associated Neurological Dysfunction |
Actual Study Start Date : | December 14, 2011 |
Actual Primary Completion Date : | August 28, 2017 |
Actual Study Completion Date : | July 19, 2018 |

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 |
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. |
- Delirium/Coma-free Days (DCFDs) [ Time Frame: 14 days ]Defined as the number of days during the 14-day intervention period (beginning on the day of randomization) that the patient was alive and experienced neither delirium nor coma.
- Mortality [ Time Frame: 30-day and 90-day ]Deaths within the specified timeframe
- Delirium Duration [ Time Frame: 14 days ]Duration of delirium during the intervention period
- Number of Participants With Torsades de Pointes [ Time Frame: 14 days plus 4-day post-study drug period (if longer than 14 days) ]
- Number of Participants With Extrapyramidal Symptoms [ Time Frame: 14 days plus 4-day post-study drug period (if longer than 14 days) ]
- Number of Participants With Neuroleptic Malignant Syndrome [ Time Frame: 14 days plus 4-day post-study drug period (if longer than 14 days) ]
- Time to Liberation From Mechanical Ventilation [ Time Frame: 30 days ]Days from randomization to successful liberation from mechanical ventilation, where "successful" indicates that liberation was followed by at least 48 hours alive and without reinitiation of invasive or noninvasive ventilation.
- Time to Final ICU Discharge [ Time Frame: 90 days ]Days from randomization to final, successful ICU discharge, where "successful" indicates that discharge was followed by at least 48 hours alive. "ICU discharge" is 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.
- Time to ICU Readmission [ Time Frame: 90 days after first ICU discharge ]Days from first ICU discharge to next ICU readmission.
- Time to Hospital Discharge [ Time Frame: 90 days ]Days from randomization to successful hospital discharge, where "successful" indicates that discharge was followed by at least 48 hours alive.

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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:
- 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
United States, Colorado | |
Denver Health/University of Colorado Health Sciences Center | |
Denver, Colorado, United States, 80204-4507 | |
United States, Connecticut | |
Yale University Medical Center | |
New Haven, Connecticut, United States, 06520-8057 | |
United States, Indiana | |
Indiana University | |
Indianapolis, Indiana, United States, 46202-2915 | |
United States, Iowa | |
University of Iowa | |
Iowa City, Iowa, United States, 52242 | |
United States, Maryland | |
University of Maryland Medical Center | |
Baltimore, Maryland, United States, 21201 | |
United States, Massachusetts | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114-2696 | |
Brigham and Women's Hospital | |
Boston, Massachusetts, United States, 02115 | |
United States, Michigan | |
University of Michigan Health System | |
Ann Arbor, Michigan, United States, 48109-5360 | |
United States, New York | |
Albert Einstein Medical College-Montefiore Medical Center | |
Bronx, New York, United States, 10461 | |
United States, North Carolina | |
University of North Carolina - Chapel Hill | |
Chapel Hill, North Carolina, United States, 27599-7248 | |
Moses Cone Health System | |
Greensboro, North Carolina, United States, 27410 | |
United States, Ohio | |
The Ohio State Medical Center | |
Columbus, Ohio, United States, 43210-1228 | |
United States, Pennsylvania | |
University of Pennsylvania | |
Philadelphia, Pennsylvania, United States, 19104-6205 | |
United States, Tennessee | |
Vanderbilt University Medical Center | |
Nashville, Tennessee, United States, 37232-8300 | |
United States, Texas | |
Baylor Health Care System | |
Dallas, Texas, United States, 75206 | |
United States, Washington | |
University of Washington | |
Seattle, Washington, United States, 98195-9472 |
Principal Investigator: | E. Wesley Ely, MD, MPH | Vanderbilt University Medical Center |
Documents provided by Wes Ely, Vanderbilt University Medical Center:
Responsible Party: | Wes Ely, Professor of Medicine, Vanderbilt University Medical Center |
ClinicalTrials.gov Identifier: | NCT01211522 |
Other Study ID Numbers: |
AG035117-01A1 101082 ( Other Identifier: Vanderbilt University Institutional Review Board ) |
First Posted: | September 29, 2010 Key Record Dates |
Results First Posted: | August 20, 2019 |
Last Update Posted: | November 18, 2019 |
Last Verified: | October 2019 |
Delirium Intensive care Mechanical ventilation Antipsychotic Haloperidol Ziprasidone |
Randomized Placebo Sepsis Sedation Long-term cognitive impairment |
Delirium Cognitive Dysfunction Confusion Neurobehavioral Manifestations Neurologic Manifestations Nervous System Diseases 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 |