Reducing ICU Delirium with Dexmedetomidine Sleep

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• University of California San Francisco
  San Francisco, California, United States 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

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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.