Status:
RECRUITING
Minimizing ICU Neurological Dysfunction With Dexmedetomidine-induced Sleep (MINDDS II)
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Delirium
Eligibility:
All Genders
60+ years
Phase:
PHASE3
Brief Summary
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 (I...
Eligibility Criteria
Inclusion
- Aged 60 years or older
- Scheduled to undergo a cardiac surgical procedure with cardiopulmonary bypass
- Planned postoperative admission to the intensive care unit (ICU)
Exclusion
- 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
Key Trial Info
Start Date :
January 6 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2029
Estimated Enrollment :
1800 Patients enrolled
Trial Details
Trial ID
NCT06192615
Start Date
January 6 2025
End Date
March 31 2029
Last Update
December 31 2025
Active Locations (14)
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1
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
2
University of California San Francisco
San Francisco, California, United States, 94117
3
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States, 60611
4
University of Iowa Carver College of Medicine
Iowa City, Iowa, United States, 522421320