The Modifying the Impact of ICU-Associated Neurological Dysfunction-USA (MIND-USA) Study

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Description

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 antipsychoticsâ¿¿haloperidol and ziprasidone, in this caseâ¿¿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 876 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), 292 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 Start Date

December 2011

Estimated Completion Date

July 2019

Interventions

Drug: Haloperidol
Drug: Ziprasidone
Drug: Placebo

Specialties

Internal Medicine: Neurology
Neurology: Dementia
Emergency Medicine: Neurology/Neurosurgery

MeSH Terms

Cognition Disorders
Delirium
Haloperidol
Sepsis
Ziprasidone

Study ID

Vanderbilt University -- AG035117-01A1

Status

Unknown

Trial ID

NCT01211522

Study Type

Interventional

Trial Phase

Phase 3

Enrollment Quota

561

Sponsor

Vanderbilt University

Inclusion Criteria

1. adult patients (>=18 years old) 2. in a medical and/or surgical ICU 3. on mechanical ventilation or non-invasive positive pressure ventilation (NIPPV), and/or requiring vasopressors due to shock 4. delirious (according to the CAM-ICU)

Exclusion Criteria

1. 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 2. Pregnancy or breastfeeding (negative pregnancy test required prior to enrollment of female patients of childbearing age) 3. 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. 4. 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 5. Ongoing maintenance therapy with typical or atypical antipsychotics 6. History of neuroleptic malignant syndrome (NMS), haloperidol allergy, or ziprasidone allergy 7. 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) 8. Inability to obtain informed consent from an authorized representative within 72 hours of meeting all inclusion criteria, i.e., developing qualifying organ dysfunction criteria.

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Study Locations and Contact Information (7)

Study Location	Distance	Name	Phone	Email
Brigham and Womens Hospital - Boston, Massachusetts	2.6 miles	Robert L Owens MD	617-983-7489	rowens@partners.org
Albert Einstein Medical CollegeMontefiore Medical Center - Bronx, New York	176.6 miles	Michelle Ng Gong MD MS	718-430-3712	mgong@montefiore.org
University of Maryland Medical Center - Baltimore, Maryland	358.9 miles	Peter Rock MD MBA	410-328-8919	prock@anes.umm.edu
Moses Cone Health System - Greensboro, North Carolina	639.9 miles	Daniel J Feinstein MD	336-832-2432	daniel.feinstein@mosescone.com
Wake Forest University - Winston-Salem, North Carolina	659.2 miles	None	None	None
University of Iowa - Iowa City, Iowa	1,050.4 miles	None	None	None
Baylor Health Care System - Dallas, Texas	1,547.9 miles	None	None	None

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