Minimizing ICU Neurological Dysfunction With Dexmedetomidine-induced Sleep (MINDDS II)

Purpose

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.

Condition

  • Delirium

Eligibility

Eligible Ages
Over 60 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Drug: Intravenous Dexmedetomidine
    Intravenous dexmedetomidine (1 μg/kg over 40 minutes, a maximal dose of 80 μg)
    Other names:
    • Intravenous Precedex
  • Drug: Sublingual Placebo
    Inert sublingual film
    Other names:
    • Placebo
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.
  • Drug: Sublingual Dexmedetomidine
    Sublingual dexmedetomidine (120 μg)
    Other names:
    • Sublingual Precedex
  • Drug: Intravenous Placebo
    Intravenous placebo of 0.9% saline administered over 40 minutes
    Other names:
    • Placebo
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.
  • Drug: Intravenous Placebo
    Intravenous placebo of 0.9% saline administered over 40 minutes
    Other names:
    • Placebo
  • Drug: Sublingual Placebo
    Inert sublingual film
    Other names:
    • Placebo

Recruiting Locations

Northwestern University Feinberg School of Medicine
Chicago 4887398, Illinois 4896861 60611
Contact:
Charles Hogue, MD

University of Iowa Carver College of Medicine
Iowa City 4862034, Iowa 4862182 522421320
Contact:
Andrew Feider, MD

University of Maryland School of Medicine
Baltimore 4347778, Maryland 4361885 21201
Contact:
Patrick Odonkor, MD

Massachusetts General Hospital
Boston 4930956, Massachusetts 6254926 02114
Contact:
Amit Bardia, MD

Beth Israel Deaconess Medical Center
Boston 4930956, Massachusetts 6254926 02215
Contact:
Shahzad Shaefi, MD

Brigham and Women's Hospital
Boston 4930956, Massachusetts 6254926 02215
Contact:
Oluwaseun Johnson-Akeju, MD

University of Nebraska Medical Center
Omaha 5074472, Nebraska 5073708 68198
Contact:
Shaun Thompson, MD

Columbia University Medical Center
New York 5128581, New York 5128638 10032
Contact:
Vivek Moitra, MD

Duke University Hospital
Durham 4464368, North Carolina 4482348 27710
Contact:
Mihai Podgoreanu, MD

Vanderbilt University Medical Center
Nashville 4644585, Tennessee 4662168 37232
Contact:
Frederic T Billings, MD

More Details

NCT ID
NCT06192615
Status
Recruiting
Sponsor
Massachusetts General Hospital

Study Contact

Oluwaseun Johnson-Akeju, MD
617-726-3030
ojohnsonakeju@partners.org

For help using this page: trialstoday@researchmatch.org or call 855-514-7001

ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center