Reducing ICU Delirium with Dexmedetomidine Sleep
Minimizing ICU Neurological Dysfunction With Dexmedetomidine-induced Sleep (MINDDS II)
PHASE3 · Massachusetts General Hospital · NCT06192615
This study is testing if a sleep-inducing medication called dexmedetomidine can help older patients recover better and avoid confusion after heart surgery in the ICU.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 1800 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | Massachusetts General Hospital (other) |
| Locations | 14 sites (Los Angeles, California and 13 other locations) |
| Trial ID | NCT06192615 on ClinicalTrials.gov |
What this trial studies
This phase III clinical trial evaluates the effects of intravenous and sublingual dexmedetomidine on postoperative delirium and functional outcomes in elderly patients following cardiac surgery. It employs a randomized, blinded, double placebo-controlled design with three arms to compare the efficacy of dexmedetomidine against placebo. The study aims to determine whether inducing sleep with dexmedetomidine can minimize neurological dysfunction in the ICU setting.
Who should consider this trial
Good fit: Ideal candidates are elderly patients aged 60 years or older who are scheduled for cardiac surgery requiring cardiopulmonary bypass and will be admitted to the ICU postoperatively.
Not a fit: Patients with preexisting cognitive impairments, severe liver failure, or those undergoing procedures requiring total circulatory arrest may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of delirium in elderly patients after cardiac surgery, leading to improved recovery and functional outcomes.
How similar studies have performed: Previous studies have shown promising results with dexmedetomidine in reducing delirium, suggesting that this approach may be effective, although this specific methodology is being tested in a novel context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Los Angeles, California and 13 other locations
- Cedars-Sinai Medical Center — Los Angeles, California, United States (NOT_YET_RECRUITING)
- University of California San Francisco — San Francisco, California, United States (NOT_YET_RECRUITING)
- Northwestern University Feinberg School of Medicine — Chicago, Illinois, United States (RECRUITING)
- University of Iowa Carver College of Medicine — Iowa City, Iowa, United States (RECRUITING)
- University of Maryland School of Medicine — Baltimore, Maryland, United States (RECRUITING)
- Massachusetts General Hospital — Boston, Massachusetts, United States (RECRUITING)
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (RECRUITING)
- Brigham and Women's Hospital — Boston, Massachusetts, United States (RECRUITING)
- Washington University School of Medicine — St Louis, Missouri, United States (NOT_YET_RECRUITING)
- University of Nebraska Medical Center — Omaha, Nebraska, United States (RECRUITING)
- Columbia University Medical Center — New York, New York, United States (RECRUITING)
- Montefiore Medical Center — The Bronx, New York, United States (NOT_YET_RECRUITING)
- Duke University Hospital — Durham, North Carolina, United States (RECRUITING)
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (RECRUITING)
Study contacts
- Principal investigator: Oluwaseun Johnson-Akeju, MD — Massachusetts General Hospital
- Study coordinator: Oluwaseun Johnson-Akeju, MD
- Email: ojohnsonakeju@partners.org
- Phone: 617-726-3030
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Delirium