The Modifying the Impact of ICU-Associated Neurological Dysfunction-USA (MIND-USA) Study
Public ClinicalTrials.gov record NCT01211522. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
MIND-USA Study: Modifying the Impact of ICU-Associated Neurological Dysfunction
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The long-term objective of the MIND-USA (Modifying the Impact of ICU-Induced Neurological Dysfunction-USA) Study is to define the role of antipsychotics in the management of delirium in vulnerable critically ill patients. We and others have shown that delirium is an independent predictor of more death, longer stay, higher cost, and long-term cognitive impairment often commensurate with moderate dementia. The rapidly expanding aging ICU population is especially vulnerable to develop delirium, with 7 of 10 medical and surgical ICU patients developing this organ dysfunction. Antipsychotics are the first-line pharmacological agents recommended to treat delirium, and over the past 30 years they gained widespread use in hospitalized patients globally prior to adequate testing of efficacy and safety for this indication. Haloperidol, the most commonly chosen antipsychotic, is used by over 80% of ICU doctors for delirium, while atypical antipsychotics are prescribed by 40%. Antipsychotics safety concerns include lethal cardiac arrhythmias, extrapyramidal symptoms, and the highly publicized increased mortality associated with their use in non-ICU geriatric populations. The overarching hypothesis is that administration of typical and atypical antipsychotics-haloperidol and ziprasidone, in this case-to critically ill patients with delirium will improve short- and long-term clinical outcomes, including days alive without acute brain dysfunction (referred to as delirium/coma-free days or DCFDs) over a 14-day period; 30-day, 90-day, and 1-year survival; ICU length of stay; incidence, severity, and/or duration of long-term neuropsychological dysfunction; and quality of life at 90-day and 1-year. To test these hypotheses, the MIND-USA Study will be a multi-center, double-blind, randomized, placebo-controlled investigation in 561 critically ill, delirious medical/surgical ICU patients who are (a) on mechanical ventilation or non-invasive positive pressure ventilation or (b) in shock on vasopressors. In each group (haloperidol, ziprasidone, and placebo), 187 patients will be enrolled and treated until delirium has resolved for 48 hours or to 14 days (whichever occurs first) and followed for 1 year.
Study identification
- NCT ID
- NCT01211522
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 566 participants
Conditions and interventions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 14, 2011 (Actual)
- Primary completion
- Aug 28, 2017 (Actual)
- Completion
- Jul 19, 2018 (Actual)
- Last update posted
- Nov 18, 2019
2011 – 2018
United States locations
- U.S. sites
- 16
- U.S. states
- 14
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Denver Health/University of Colorado Health Sciences Center | Denver | Colorado | 80204-4507 | — |
| Yale University Medical Center | New Haven | Connecticut | 06520-8057 | — |
| Indiana University | Indianapolis | Indiana | 46202-2915 | — |
| University of Iowa | Iowa City | Iowa | 52242 | — |
| University of Maryland Medical Center | Baltimore | Maryland | 21201 | — |
| Massachusetts General Hospital | Boston | Massachusetts | 02114-2696 | — |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | — |
| University of Michigan Health System | Ann Arbor | Michigan | 48109-5360 | — |
| Albert Einstein Medical College-Montefiore Medical Center | The Bronx | New York | 10461 | — |
| University of North Carolina - Chapel Hill | Chapel Hill | North Carolina | 27599-7248 | — |
| Moses Cone Health System | Greensboro | North Carolina | 27410 | — |
| The Ohio State Medical Center | Columbus | Ohio | 43210-1228 | — |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104-6205 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232-8300 | — |
| Baylor Health Care System | Dallas | Texas | 75206 | — |
| University of Washington | Seattle | Washington | 98195-9472 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01211522, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Nov 18, 2019 · Synced Oct 23, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01211522 live on ClinicalTrials.gov.