Clinical trial NCT06192615: Minimizing ICU Neurological Dysfunction With Dexmedetomidine-induced Sleep (MINDDS II)
Official title: Minimizing ICU Neurological Dysfunction With Dexmedetomidine-induced Sleep (MINDDS II)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Delirium
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2024-01-05
Enrollment: 1800
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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)
* 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

Primary outcomes:
measure: Delirium
timeFrame: Postoperative day 1
Secondary outcomes:
measure: Delirium
timeFrame: Postoperative Day 1 to Day 7
measure: Delirium Severity
timeFrame: Postoperative day 1 to day 7
measure: Telephonic Montreal Cognitive Assessment
timeFrame: 30, 180 and 365 days
measure: Global Health
timeFrame: 30, 180 and 365 days
measure: Pain at Rest and Upon Exertion
timeFrame: Postoperative day 1 to day 7
measure: Opioid and Analgesic Administration
timeFrame: 48 hours postoperatively
measure: Hospital Length of Stay
timeFrame: Postoperatively until discharge, an average of six days
measure: Intensive Care Unit Length of Stay
timeFrame: Postoperatively until discharge, an average of 24 hours
measure: Readmission
timeFrame: 30 days postoperatively
measure: Inpatient Morbidity
timeFrame: 30 days postoperatively
measure: Mortality
timeFrame: Postoperatively until discharge, an average of six days, and at 30, 180 and 365 days postoperatively
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa Carver College of Medicine
state: Iowa
city: Baltimore
country: United States
facility: University of Maryland School of Medicine
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Durham
country: United States
facility: Duke University Hospital
state: North Carolina
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Massachusetts General Hospital
name: Oluwaseun Johnson-Akeju, MD
role: PRINCIPAL_INVESTIGATOR
References: