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

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)