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NCT01211522 · ClinicalTrials.gov registry record · Phase 3
The Modifying the Impact of ICU-Associated Neurological Dysfunction-USA (MIND-USA) Study
A Phase 3 study of Delirium and Impaired Cognition, sponsored by Vanderbilt University Medical Center.
- Completed
- Registry status
- Phase 3
- Development phase
- 566
- Enrollment target
- 16
- Study locations
NCT01211522 is a Phase 3 study of Delirium and Impaired Cognition that has completed, run by Vanderbilt University Medical Center. The registered enrollment target is 566 participants, below the 879-participant average among 62 other Delirium trials with a reported enrollment target (36% lower). The trial reports 16 study locations across 14 states.
The verdict
NCT01211522, a Phase 3 study of Delirium and Impaired Cognition, has completed, sponsored by Vanderbilt University Medical Center.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 566 participants
- Enrollment target
- 16
- Study locations
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?
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, categorized as Phase 3. The registered enrollment target is 566 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 879-participant average among 62 other Delirium trials with a reported enrollment target (36% lower). The listed sponsor is Vanderbilt University Medical Center, which has 677 total studies on file at ClinicalTrials.gov.
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.
NCT01211522 reports 16 study locations spanning 14 distinct geographic areas - top geographies include Massachusetts, North Carolina, Colorado.
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.
What interventions are being tested in trial NCT01211522?
The interventions under investigation include: Placebo (DRUG), Haloperidol (DRUG), Ziprasidone (DRUG).
Who is sponsoring clinical trial NCT01211522?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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