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

• Register: ClinicalTrials.gov
• Last refreshed on: 11 February 2013
• Main ID: NCT01211522
• Date of registration: 28/09/2010
• Primary sponsor: Vanderbilt University
• Public title: The Modifying the Impact of ICU-Associated Neurological Dysfunction-USA (MIND-USA) Study MIND-USA
• Scientific title: The MIND-USA Study: Modifying the Impact of ICU-Associated Neurological Dysfunction
• Date of first enrolment: December 2011
• Target sample size: 876
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01211522
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Countries of recruitment

United States

Contacts

• Name: E. Wesley Ely, MD, MPH

• Name: E. Wesley Ely, MD, MPH
• Affiliation: Vanderbilt University

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Delirium

Impaired Cognition

Long Term Psychologic Disorders

Intervention(s)

Drug: Haloperidol

Drug: Placebo

Drug: Ziprasidone

Primary Outcome(s)

Delirium/coma-free days [Time Frame: 14 days]

Secondary Outcome(s)

Delirium duration [Time Frame: 14 days]

Extrapyramidal symptoms [Time Frame: 14 days]

Hospital length of stay [Time Frame: 1 to 90 days]

Hospital readmission [Time Frame: 1 to 365 days]

ICU length of stay [Time Frame: 1 to 90 days]

ICU readmission [Time Frame: 1 to 90 days]

Neuroleptic malignant syndrome [Time Frame: 14 days]

Neuropsychological dysfunction [Time Frame: 3-month, 12-month]

Posttraumatic stress disorder [Time Frame: 3-month, 12-month]

QTc prolongation [Time Frame: 14 days]

Quality of life [Time Frame: 3-month, 12-month]

Survival [Time Frame: 30-day, 90-day, and 1-year]

Ventilator-free days [Time Frame: 14 days]

Secondary ID(s)

101082

AG035117-01A1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors