Status:
COMPLETED
The Modifying the Impact of ICU-Associated Neurological Dysfunction-USA (MIND-USA) Study
Lead Sponsor:
Vanderbilt University Medical Center
Conditions:
Delirium
Impaired Cognition
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 cri...
Detailed Description
The primary and secondary outcomes of the MIND-USA investigation will be analyzed both according to the individual comparisons by group of "haloperidol treated" vs. "placebo treated" and "ziprasidone ...
Eligibility Criteria
Inclusion
- adult patients (≥18 years old)
- in a medical and/or surgical ICU
- on mechanical ventilation or non-invasive positive pressure ventilation (NIPPV), and/or requiring vasopressors due to shock
- delirious (according to the CAM-ICU)
Exclusion
- 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
- Pregnancy or breastfeeding (negative pregnancy test required prior to enrollment of female patients of childbearing age)
- 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.
- 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
- Ongoing maintenance therapy with typical or atypical antipsychotics
- History of neuroleptic malignant syndrome (NMS), haloperidol allergy, or ziprasidone allergy
- 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)
- Inability to obtain informed consent from an authorized representative within 72 hours of meeting all inclusion criteria, i.e., developing qualifying organ dysfunction criteria.
Key Trial Info
Start Date :
December 14 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 19 2018
Estimated Enrollment :
566 Patients enrolled
Trial Details
Trial ID
NCT01211522
Start Date
December 14 2011
End Date
July 19 2018
Last Update
November 18 2019
Active Locations (16)
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1
Denver Health/University of Colorado Health Sciences Center
Denver, Colorado, United States, 80204-4507
2
Yale University Medical Center
New Haven, Connecticut, United States, 06520-8057
3
Indiana University
Indianapolis, Indiana, United States, 46202-2915
4
University of Iowa
Iowa City, Iowa, United States, 52242