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

PHASE3CompletedINTERVENTIONAL
Enrollment

566

Participants

Timeline

Start Date

December 14, 2011

Primary Completion Date

August 28, 2017

Study Completion Date

July 19, 2018

Conditions
DeliriumImpaired CognitionLong Term Psychologic Disorders
Interventions
DRUG

Haloperidol

Haloperidol, up to 10mg q12 hours, will be administered intravenously (IV) by bolus over up to 5 minutes at concentrations of 5mg/mL. Patient will only receive IV while in the ICU.

DRUG

Ziprasidone

Ziprasidone, up to 20mg q12 hours, will be administered intravenously (IV) by bolus over up to 5 minutes at concentrations of 10mg/mL. Patient will only receive IV while in the ICU.

DRUG

Placebo

Placebo, up to 10mL q12 hours, will be administered intravenously (IV) by bolus over up to 5 minutes. Patient will only receive IV while in the ICU.

Trial Locations (16)

10461

Albert Einstein Medical College-Montefiore Medical Center, The Bronx

21201

University of Maryland Medical Center, Baltimore

27410

Moses Cone Health System, Greensboro

52242

University of Iowa, Iowa City

75206

Baylor Health Care System, Dallas

80204-4507

Denver Health/University of Colorado Health Sciences Center, Denver

06520-8057

Yale University Medical Center, New Haven

46202-2915

Indiana University, Indianapolis

02114-2696

Massachusetts General Hospital, Boston

02115

Brigham and Women's Hospital, Boston

48109-5360

University of Michigan Health System, Ann Arbor

27599-7248

University of North Carolina - Chapel Hill, Chapel Hill

43210-1228

The Ohio State Medical Center, Columbus

19104-6205

University of Pennsylvania, Philadelphia

37232-8300

Vanderbilt University Medical Center, Nashville

98195-9472

University of Washington, Seattle

All Listed Sponsors
lead

Vanderbilt University Medical Center

OTHER

NCT01211522 - The Modifying the Impact of ICU-Associated Neurological Dysfunction-USA (MIND-USA) Study | Biotech Hunter | Biotech Hunter