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

Description

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.

Conditions

Delirium

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Delirium
Intervention / Treatment

-

Contacts and Locations

Chicago

Northwestern University Feinberg School of Medicine, Chicago, Illinois, United States, 60611

Iowa City

University of Iowa Carver College of Medicine, Iowa City, Iowa, United States, 522421320

Baltimore

University of Maryland School of Medicine, Baltimore, Maryland, United States, 21201

Boston

Massachusetts General Hospital, Boston, Massachusetts, United States, 02114

Boston

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States, 02215

Boston

Brigham and Women's Hospital, Boston, Massachusetts, United States, 02215

Saint Louis

Washington University School of Medicine, Saint Louis, Missouri, United States, 63110

Omaha

University of Nebraska Medical Center, Omaha, Nebraska, United States, 68198

Bronx

Montefiore Medical Center, Bronx, New York, United States, 10467

New York

Columbia University Medical Center, New York, New York, United States, 10032

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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)
  • * 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)
  • * History of obstructive sleep apnea
  • * 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

Ages Eligible for Study

60 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Massachusetts General Hospital,

Oluwaseun Johnson-Akeju, MD, PRINCIPAL_INVESTIGATOR, Massachusetts General Hospital

Study Record Dates

2029-03-31