The Modifying the Impact of ICU-Associated Neurological Dysfunction-USA (MIND-USA) Study (MIND-USA)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01211522|
Recruitment Status : Recruiting
First Posted : September 29, 2010
Last Update Posted : April 25, 2018
|Condition or disease||Intervention/treatment||Phase|
|Delirium Impaired Cognition Long Term Psychologic Disorders||Drug: Haloperidol Drug: Ziprasidone Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||561 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||MIND-USA Study: Modifying the Impact of ICU-Associated Neurological Dysfunction|
|Study Start Date :||December 2011|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||July 2019|
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.
Other Name: Haldol
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.
Other Name: Geodon
Placebo Comparator: 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.
- Delirium/coma-free days (DCFDs) [ Time Frame: 14 days ]Defined as the number of days during the 14-day intervention period (beginning on the day of randomization) that the patient was alive and experienced neither delirium nor coma.
- Survival [ Time Frame: 30-day, 90-day, and 1-year ]Time to death
- Delirium duration [ Time Frame: 14 days ]Duration of delirium during the intervention period
- Time to final ICU discharge [ Time Frame: 90 days ]Days from randomization to final, successful ICU discharge, where "successful" indicates that discharge was followed by at least 48 hours alive. "ICU discharge" is represented by readiness for ICU discharge indicated by a physician order for transfer to a lower level of care even if a bed availability problems prevent actual discharge from the ICU.
- Time to hospital discharge [ Time Frame: 90 days ]Days from randomization to successful hospital discharge, where "successful" indicates that discharge was followed by at least 48 hours alive.
- Time to liberation from mechanical ventilation [ Time Frame: 30 days ]Days from randomization to successful liberation from mechanical ventilation, where "successful" indicates that liberation was followed by at least 48 hours alive and without reinitiation of invasive or noninvasive ventilation.
- Time to ICU readmission [ Time Frame: 90 days after first ICU discharge ]Days from first ICU discharge to next ICU readmission.
- Hospital readmission [ Time Frame: 365 days ]Readmission to the hospital after index hospital discharge determined by self-report during follow-up interviews.
- Neuropsychological dysfunction [ Time Frame: 3 and 12 months post-randomization ]Assessed using Telephone Interview for Cognitive Status (TICS), Digit Span and Similarities from the WAIS-III, Confusion Assessment Method (CAM) Telephone version, Paragraph Recall (both immediate and delayed portions) from the WMS-III, Controlled Oral Word Association Test (COWA), and the Hayling Test. These assessments will be scored in standard fashion and will allow us to characterize cognitive impairment across patients.
- Quality of life [ Time Frame: 3 and 12 months post-randomization ]Assessed using the Katz ADL, Employment Questionnaire, Functional Activities Questionnaire (FAQ), EQ-5D-3L and a Healthcare Utilization Survey.
- Posttraumatic stress disorder [ Time Frame: 3 and 12 months post-randomization ]Assessed using the PTSD Checklist (PCL-S, event specific version) with respondents instructed to answer questions in reference to the ICU experience.
- Torsades de pointes [ Time Frame: 14 days plus 4-day post-study drug period (if longer than 14 days) ]Incidence of tachyarrhythmias (as documented by telemetry rhythm strip and/or 12-lead ECG) determined to be torsades de pointes by the site primary investigator and confirmed by the coordinating center.
- Extrapyramidal symptoms [ Time Frame: 14 days plus 4-day post-study drug period (if longer than 14 days) ]Listing of any incidence of EPS, including treatment group and circumstances, during the study drug intervention period.
- Neuroleptic malignant syndrome [ Time Frame: 14 days plus 4-day post-study drug period (if longer than 14 days) ]Listing of any incidence of NMS, including treatment group and circumstances, during the study drug intervention period.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01211522
|Contact: E. Wesley Ely, MD, MPHfirstname.lastname@example.org|
|Contact: Timothy D Girard, MD, MSCIemail@example.com|
|United States, Colorado|
|Denver Health/University of Colorado Health Sciences Center||Recruiting|
|Denver, Colorado, United States, 80204-4507|
|Contact: Ivor S Douglas, MD 303-436-5905 firstname.lastname@example.org|
|Principal Investigator: Ivor S Douglas, MD|
|United States, Connecticut|
|Yale University Medical Center||Recruiting|
|New Haven, Connecticut, United States, 06520-8057|
|Contact: Margaret A Pisani, MD 203-785-3627 email@example.com|
|Principal Investigator: Margaret A Pisani, MD|
|United States, Indiana|
|Indiana University||Active, not recruiting|
|Indianapolis, Indiana, United States, 46202-2915|
|United States, Iowa|
|University of Iowa||Active, not recruiting|
|Iowa City, Iowa, United States, 52242|
|United States, Maryland|
|University of Maryland Medical Center||Recruiting|
|Baltimore, Maryland, United States, 21201|
|Contact: Peter Rock, MD, MBA 410-328-8919 firstname.lastname@example.org|
|Principal Investigator: Peter Rock, MD, MBA|
|United States, Massachusetts|
|Massachusetts General Hospital||Active, not recruiting|
|Boston, Massachusetts, United States, 02114-2696|
|Brigham and Women's Hospital||Recruiting|
|Boston, Massachusetts, United States, 02115|
|Contact: Robert L Owens, MD 617-983-7489 email@example.com|
|Principal Investigator: Robert L Owens, MD|
|United States, Michigan|
|University of Michigan Health System||Recruiting|
|Ann Arbor, Michigan, United States, 48109-5360|
|Contact: Robert C Hyzy, MD 734-936-5201 firstname.lastname@example.org|
|Principal Investigator: Robert C Hyzy, MD|
|United States, New York|
|Albert Einstein Medical College-Montefiore Medical Center||Recruiting|
|Bronx, New York, United States, 10461|
|Contact: Michelle Ng Gong, MD, MS 718-430-3712 email@example.com|
|Principal Investigator: Michelle Ng Gong, MD, MS|
|United States, North Carolina|
|University of North Carolina - Chapel Hill||Recruiting|
|Chapel Hill, North Carolina, United States, 27599-7248|
|Contact: Shannon S Carson, MD 919-966-2531 firstname.lastname@example.org|
|Principal Investigator: Shannon S Carson, MD|
|Moses Cone Health System||Recruiting|
|Greensboro, North Carolina, United States, 27410|
|Contact: Daniel J Feinstein, MD 336-832-2432 email@example.com|
|Principal Investigator: Daniel J Feinstein, MD|
|Wake Forest University||Withdrawn|
|Winston-Salem, North Carolina, United States, 27157|
|United States, Ohio|
|The Ohio State Medical Center||Recruiting|
|Columbus, Ohio, United States, 43210-1228|
|Contact: Matthew C. Exline, MD, MPH 614-293-4925 firstname.lastname@example.org|
|Principal Investigator: Matthew C. Exline, MD, MPH|
|United States, Pennsylvania|
|University of Pennsylvania||Active, not recruiting|
|Philadelphia, Pennsylvania, United States, 19104-6205|
|United States, Tennessee|
|Vanderbilt University Medical Center||Recruiting|
|Nashville, Tennessee, United States, 37232-8300|
|Contact: Wes E. Ely, MD, MPH 615-936-3702 email@example.com|
|Contact: Tim Girard, MD, MPH 1-412-532-9779 firstname.lastname@example.org|
|United States, Texas|
|Baylor Health Care System||Active, not recruiting|
|Dallas, Texas, United States, 75206|
|United States, Washington|
|University of Washington||Recruiting|
|Seattle, Washington, United States, 98195-9472|
|Contact: Catherine Hough, MD 206-744-3356 email@example.com|
|Principal Investigator: Catherine Hough, MD|
|Principal Investigator:||E. Wesley Ely, MD, MPH||Vanderbilt University Medical Center|