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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01211522|
Recruitment Status : Active, not recruiting
First Posted : September 29, 2010
Last Update Posted : September 12, 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)|
|Actual Enrollment :||1183 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Masking Description:||Double blind, placebo controlled|
|Official Title:||MIND-USA Study: Modifying the Impact of ICU-Associated Neurological Dysfunction|
|Study Start Date :||December 2011|
|Actual Primary Completion Date :||July 16, 2018|
|Estimated Study Completion Date :||July 15, 2025|
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01211522
|United States, Colorado|
|Denver Health/University of Colorado Health Sciences Center|
|Denver, Colorado, United States, 80204-4507|
|United States, Connecticut|
|Yale University Medical Center|
|New Haven, Connecticut, United States, 06520-8057|
|United States, Indiana|
|Indianapolis, Indiana, United States, 46202-2915|
|United States, Iowa|
|University of Iowa|
|Iowa City, Iowa, United States, 52242|
|United States, Maryland|
|University of Maryland Medical Center|
|Baltimore, Maryland, United States, 21201|
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114-2696|
|Brigham and Women's Hospital|
|Boston, Massachusetts, United States, 02115|
|United States, Michigan|
|University of Michigan Health System|
|Ann Arbor, Michigan, United States, 48109-5360|
|United States, New York|
|Albert Einstein Medical College-Montefiore Medical Center|
|Bronx, New York, United States, 10461|
|United States, North Carolina|
|University of North Carolina - Chapel Hill|
|Chapel Hill, North Carolina, United States, 27599-7248|
|Moses Cone Health System|
|Greensboro, North Carolina, United States, 27410|
|United States, Ohio|
|The Ohio State Medical Center|
|Columbus, Ohio, United States, 43210-1228|
|United States, Pennsylvania|
|University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104-6205|
|United States, Tennessee|
|Vanderbilt University Medical Center|
|Nashville, Tennessee, United States, 37232-8300|
|United States, Texas|
|Baylor Health Care System|
|Dallas, Texas, United States, 75206|
|United States, Washington|
|University of Washington|
|Seattle, Washington, United States, 98195-9472|
|Principal Investigator:||E. Wesley Ely, MD, MPH||Vanderbilt University Medical Center|