Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
The Modifying the Impact of ICU-Associated Neurological Dysfunction-USA (MIND-USA) Study
NCT01211522 · View on ClinicalTrials.gov ↗
Study Summary
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
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Haloperidol
- DRUG Ziprasidone
Study Locations (16)
Massachusetts
- Massachusetts General Hospital — Boston
- Brigham and Women's Hospital — Boston
North Carolina
- University of North Carolina - Chapel Hill — Chapel Hill
- Moses Cone Health System — Greensboro
Colorado
- Denver Health/University of Colorado Health Sciences Center — Denver
Connecticut
- Yale University Medical Center — New Haven
Indiana
- Indiana University — Indianapolis
Iowa
- University of Iowa — Iowa City
Maryland
- University of Maryland Medical Center — Baltimore
Michigan
- University of Michigan Health System — Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 566 participants |
| Start Date | 2011-12-14 |
| Est. Completion | 2018-07-19 |
| Phase | Phase 3 |
Interested in This Trial?
Always speak with your doctor before enrolling in a clinical trial.
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01211522
The ClinicalTrials.gov registry entry for NCT01211522 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 566 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vanderbilt University Medical Center, which has 695 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Delirium appearing as the primary indexed condition, and to 3 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01211522 reports 16 study locations spanning 14 distinct geographic areas — top geographies include Massachusetts, North Carolina, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT01211522 about?
NCT01211522 is a clinical study titled "The Modifying the Impact of ICU-Associated Neurological Dysfunction-USA (MIND-USA) Study". 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 dea...
What is the current status of trial NCT01211522?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 566 participants. The study started on 2011-12-14. Estimated completion is 2018-07-19.
What conditions does trial NCT01211522 study?
This clinical trial studies the following conditions: Delirium, Impaired Cognition, Long Term Psychologic Disorders. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01211522?
The interventions under investigation include: Placebo (DRUG), Haloperidol (DRUG), Ziprasidone (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01211522?
This trial is sponsored by Vanderbilt University Medical Center, which has 695 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01211522 being conducted?
This trial has 16 study locations across Colorado, Connecticut, Indiana, Iowa, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.