Minimizing ICU Neurological Dysfunction With Dexmedetomidine-induced Sleep (MINDDS II)
MINDDS II
1 other identifier
interventional
1,800
1 country
14
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 (IV) and sublingual dexmedetomidine on postoperative delirium and functional outcomes after surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2025
Typical duration for phase_3
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 21, 2023
CompletedFirst Posted
Study publicly available on registry
January 5, 2024
CompletedStudy Start
First participant enrolled
January 6, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 31, 2029
December 31, 2025
January 1, 2025
2.8 years
December 21, 2023
December 29, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Delirium
The primary outcome will be delirium occurring on postoperative day one. Delirium will be assessed using the Confusion Assessment Method (CAM) twice daily. Delirium will be defined as present if either the morning or afternoon assessment are positive for delirium.
Postoperative day 1
Secondary Outcomes (11)
Delirium
Postoperative Day 1 to Day 7
Delirium Severity
Postoperative day 1 to day 7
Telephonic Montreal Cognitive Assessment
30, 180 and 365 days
Global Health
30, 180 and 365 days
Pain at Rest and Upon Exertion
Postoperative day 1 to day 7
- +6 more secondary outcomes
Study Arms (3)
Intravenous Dexmedetomidine
EXPERIMENTALAfter 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.
Sublingual Dexmedetomidine
EXPERIMENTALAfter 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
PLACEBO COMPARATORAfter 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.
Interventions
Intravenous dexmedetomidine (1 μg/kg over 40 minutes, a maximal dose of 80 μg)
Sublingual dexmedetomidine (120 μg)
Intravenous placebo of 0.9% saline administered over 40 minutes
Eligibility Criteria
You may qualify if:
- 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 may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
University of California San Francisco
San Francisco, California, 94117, United States
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611, United States
University of Iowa Carver College of Medicine
Iowa City, Iowa, 522421320, United States
University of Maryland School of Medicine
Baltimore, Maryland, 21201, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02215, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Columbia University Medical Center
New York, New York, 10032, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
Duke University Hospital
Durham, North Carolina, 27710, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Oluwaseun Johnson-Akeju, MD
Massachusetts General Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Anesthetist-in-Chief
Study Record Dates
First Submitted
December 21, 2023
First Posted
January 5, 2024
Study Start
January 6, 2025
Primary Completion (Estimated)
October 31, 2027
Study Completion (Estimated)
March 31, 2029
Last Updated
December 31, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF