Minimizing ICU Neurological Dysfunction With Dexmedetomidine-induced Sleep (MINDDS II)
Status: Recruiting
Location: See all (12) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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 (IV) and sublingual dexmedetomidine on postoperative delirium and functional outcomes after surgery.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 60
Healthy Volunteers: f
View:
• Aged 60 years or older
• Scheduled to undergo a cardiac surgical procedure with cardiopulmonary bypass
• Planned postoperative admission to the intensive care unit (ICU)
Locations
United States
Iowa
University of Iowa Carver College of Medicine
NOT_YET_RECRUITING
Iowa City
Illinois
Northwestern University Feinberg School of Medicine
NOT_YET_RECRUITING
Chicago
Massachusetts
Beth Israel Deaconess Medical Center
NOT_YET_RECRUITING
Boston
Brigham and Women's Hospital
NOT_YET_RECRUITING
Boston
Massachusetts General Hospital
RECRUITING
Boston
Maryland
University of Maryland School of Medicine
NOT_YET_RECRUITING
Baltimore
Missouri
Washington University School of Medicine
NOT_YET_RECRUITING
St Louis
North Carolina
Duke University Hospital
NOT_YET_RECRUITING
Durham
Nebraska
University of Nebraska Medical Center
NOT_YET_RECRUITING
Omaha
New York
Columbia University Medical Center
NOT_YET_RECRUITING
New York
Montefiore Medical Center
NOT_YET_RECRUITING
The Bronx
Tennessee
Vanderbilt University Medical Center
NOT_YET_RECRUITING
Nashville
Contact Information
Primary
Oluwaseun Johnson-Akeju, MD
ojohnsonakeju@partners.org
617-726-3030
Backup
Ariel Mueller, MA
almueller@mgh.harvard.edu
6177269252
Time Frame
Start Date: 2025-01-06
Estimated Completion Date: 2029-03-31
Participants
Target number of participants: 1800
Treatments
Experimental: 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.
Experimental: 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.
Placebo_comparator: 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.
Related Therapeutic Areas
Sponsors
Leads: Massachusetts General Hospital