Actively Recruiting
Minimizing ICU Neurological Dysfunction With Dexmedetomidine-induced Sleep (MINDDS II)
Led by Massachusetts General Hospital · Updated on 2025-12-31
1800
Participants Needed
14
Research Sites
220 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a pragmatic phase III, randomized, blinded, double placebo-controlled, three-arm trial of elderly patients following cardiac surgery to assess the relationship between nighttime intravenous (IV) and sublingual dexmedetomidine on postoperative delirium and functional outcomes after surgery.
CONDITIONS
Official Title
Minimizing ICU Neurological Dysfunction With Dexmedetomidine-induced Sleep (MINDDS II)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 60 years or older
- Scheduled to undergo a cardiac surgical procedure with cardiopulmonary bypass
- Planned postoperative admission to the intensive care unit (ICU)
You will not qualify if you...
- Allergy or hypersensitivity to dexmedetomidine or the placebo study medication
- Preexisting diagnosis of Alzheimer's Disease or Related Dementia, severe cognitive impairment or delirium at baseline
- Severe liver failure (Child-Pugh score > 5)
- Severe deficit(s) due to structural or anoxic brain damage
- Undergoing a surgical procedure requiring total circulatory arrest
- SARS-CoV-2 positive or symptomatic (e.g., fever, cough, loss of taste/smell)
- Blind, deaf, or unable to communicate in English
- Patients experiencing circumstances for which long-term follow-up might be difficult (e.g., homelessness, active psychotic disorder, or substance abuse)
- Co-enrollment in other interventional studies that, in the opinion of the site investigator and/or PI, might interfere with study participation, collection, or interpretation of the study data
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 14 locations
1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Not Yet Recruiting
2
University of California San Francisco
San Francisco, California, United States, 94117
Not Yet Recruiting
3
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States, 60611
Actively Recruiting
4
University of Iowa Carver College of Medicine
Iowa City, Iowa, United States, 522421320
Actively Recruiting
5
University of Maryland School of Medicine
Baltimore, Maryland, United States, 21201
Actively Recruiting
6
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
7
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Actively Recruiting
8
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02215
Actively Recruiting
9
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Not Yet Recruiting
10
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Actively Recruiting
11
Columbia University Medical Center
New York, New York, United States, 10032
Actively Recruiting
12
Montefiore Medical Center
The Bronx, New York, United States, 10467
Not Yet Recruiting
13
Duke University Hospital
Durham, North Carolina, United States, 27710
Actively Recruiting
14
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
Actively Recruiting
Research Team
O
Oluwaseun Johnson-Akeju, MD
CONTACT
A
Ariel Mueller, MA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here