The Modifying the Impact of ICU-Associated Neurological Dysfunction-USA (MIND-USA) Study
Status:
Completed
Trial end date:
2018-07-19
Target enrollment:
Participant gender:
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 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.
Phase:
Phase 3
Details
Lead Sponsor:
Vanderbilt University Vanderbilt University Medical Center