Minimizing ICU Neurological Dysfunction With Dexmedetomidine-induced Sleep (MINDDS II)
NCT ID: NCT06192615
Last Updated: 2025-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
1800 participants
INTERVENTIONAL
2025-01-06
2029-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Intravenous Dexmedetomidine
After admission to the ICU and discontinuation of mechanical ventilation, intravenous dexmedetomidine (1 μg/kg over 40 minutes, a maximal dose of 80 μg) and a sublingual placebo (inert film) will be administered nightly for the first three nights while the patient is in the intensive care unit.
Intravenous Dexmedetomidine
Intravenous dexmedetomidine (1 μg/kg over 40 minutes, a maximal dose of 80 μg)
Sublingual Placebo
Inert sublingual film
Sublingual Dexmedetomidine
After admission to the ICU and discontinuation of mechanical ventilation, sublingual dexmedetomidine (120 μg) and an intravenous placebo (0.9% saline over 40 minutes) will be administered nightly for the first three nights while the patient is in the intensive care unit.
Sublingual Dexmedetomidine
Sublingual dexmedetomidine (120 μg)
Intravenous Placebo
Intravenous placebo of 0.9% saline administered over 40 minutes
Placebo
After admission to the ICU and discontinuation of mechanical ventilation, an intravenous placebo (0.9% saline over 40 minutes) and a sublingual placebo (inert film) will be administered nightly for the first three nights while the patient is in the intensive care unit.
Intravenous Placebo
Intravenous placebo of 0.9% saline administered over 40 minutes
Sublingual Placebo
Inert sublingual film
Interventions
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Intravenous Dexmedetomidine
Intravenous dexmedetomidine (1 μg/kg over 40 minutes, a maximal dose of 80 μg)
Sublingual Dexmedetomidine
Sublingual dexmedetomidine (120 μg)
Intravenous Placebo
Intravenous placebo of 0.9% saline administered over 40 minutes
Sublingual Placebo
Inert sublingual film
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Scheduled to undergo a cardiac surgical procedure with cardiopulmonary bypass
* Planned postoperative admission to the intensive care unit (ICU)
Exclusion Criteria
* 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
60 Years
ALL
No
Sponsors
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Massachusetts General Hospital
OTHER
Responsible Party
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Oluwaseun Johnson-Akeju, MD, MMSc
Anesthetist-in-Chief
Principal Investigators
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Oluwaseun Johnson-Akeju, MD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Cedars-Sinai Medical Center
Los Angeles, California, United States
University of California San Francisco
San Francisco, California, United States
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States
University of Iowa Carver College of Medicine
Iowa City, Iowa, United States
University of Maryland School of Medicine
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Washington University School of Medicine
St Louis, Missouri, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Columbia University Medical Center
New York, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Duke University Hospital
Durham, North Carolina, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Countries
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Central Contacts
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Facility Contacts
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Abirami Kumaresan, MD
Role: primary
Matthieu Legrand, MD
Role: primary
Charles Hogue, MD
Role: primary
Andrew Feider, MD
Role: primary
Patrick Odonkor, MD
Role: primary
Amit Bardia, MD
Role: primary
Shahzad Shaefi, MD
Role: primary
Oluwaseun Johnson-Akeju, MD
Role: primary
Ben Palanca, MD
Role: primary
Shaun Thompson, MD
Role: primary
Vivek Moitra, MD
Role: primary
Matthias Eikermann, MD
Role: primary
Mihai Podgoreanu, MD
Role: primary
Frederic T Billings, MD
Role: primary
Other Identifiers
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2023P003359
Identifier Type: -
Identifier Source: org_study_id