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.
Brief Title
Minimizing ICU Neurological Dysfunction With Dexmedetomidine-induced Sleep (MINDDS II)
Categories
Central Contacts
Central Contact Role
Contact
Central Contact Phone
617-726-3030
Central Contact Email
ojohnsonakeju@partners.org
Central Contact Role
Contact
Central Contact Phone
6177269252
Central Contact Email
almueller@mgh.harvard.edu
Completion Date
Completion Date Type
Estimated
Conditions
Delirium
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)
* 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
* 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
Inclusion 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)
* Aged 60 years or older
* Scheduled to undergo a cardiac surgical procedure with cardiopulmonary bypass
* Planned postoperative admission to the intensive care unit (ICU)
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
60 Years
NCT Id
NCT06192615
Org Class
Other
Org Full Name
Massachusetts General Hospital
Org Study Id
2023P003359
Overall Status
Recruiting
Phases
Phase 3
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
Minimizing ICU Neurological Dysfunction With Dexmedetomidine-induced Sleep (MINDDS II)
Primary Outcomes
Outcome Description
The primary outcome will be delirium occurring on postoperative day one. Delirium will be assessed using the Confusion Assessment Method (CAM) twice daily. Delirium will be defined as present if either the morning or afternoon assessment are positive for delirium.
Outcome Measure
Delirium
Outcome Time Frame
Postoperative day 1
Secondary Outcomes
Outcome Description
Postoperative delirium will also be assessed as a secondary outcome assessed within the first three days after surgery, and separately within the first seven days following surgery. Delirium will be assessed using the CAM in the same fashion as the primary outcome. In the event the patient is reintubated the CAM-ICU may also be used to assess for postoperative delirium as a secondary outcome.
Outcome Time Frame
Postoperative Day 1 to Day 7
Outcome Measure
Delirium
Outcome Description
Delirium severity will be assessed using the CAM-Severity (CAM-S) within the first three days following surgery, and separately within the first seven days following surgery. The CAM-S ranges from 0 (no delirium features) to 19, with higher scores indicating worsening delirium severity.
Outcome Time Frame
Postoperative day 1 to day 7
Outcome Measure
Delirium Severity
Outcome Description
Global cognitive function will be assessed with the T-MoCA in-hospital and at three time points after hospital discharge. Different versions of the T-MOCA will be administered at each time point to minimize learning effects. The T-MoCA ranges from 0 (worst) to 22 (best) points, does not require visual cues or writing, and importantly, can be administered over the phone.
Outcome Time Frame
30, 180 and 365 days
Outcome Measure
Telephonic Montreal Cognitive Assessment
Outcome Description
Global health will be assessed at 30, 180 and 365 days using the Patient Reported Outcome Measurement Information System (PROMIS) 29 Profile version 2.1. This assessment results in several subscale scores, each reported as a t-score.
Outcome Time Frame
30, 180 and 365 days
Outcome Measure
Global Health
Outcome Description
Pain will be assessed within the first seven days following surgery, using a trajectory of pain scores at rest and upon exertion/deep breathing. Pain scores will be elicited from patients daily using the Pain Numeric Rating Scale.
Outcome Time Frame
Postoperative day 1 to day 7
Outcome Measure
Pain at Rest and Upon Exertion
Outcome Description
Outcomes for opioid administration will evaluate the (a) frequency and (b) total consumption, defined as morphine equivalents, in the first 24 and 48 hours postoperatively. These will be captured based off medical record review.
Outcome Time Frame
48 hours postoperatively
Outcome Measure
Opioid and Analgesic Administration
Outcome Description
Hospital length of stay will be defined as the number of days after surgery until the time of discharge from the hospital.
Outcome Time Frame
Postoperatively until discharge, an average of six days
Outcome Measure
Hospital Length of Stay
Outcome Description
Intensive Care Unit (ICU) length of stay will be calculated as the time from discharge from the initial index ICU stay minus the time of admission into the cardiovascular ICU and will be reported in hours.
Outcome Time Frame
Postoperatively until discharge, an average of 24 hours
Outcome Measure
Intensive Care Unit Length of Stay
Outcome Description
Hospital readmission will be evaluated within the first 30 days postoperatively using the Society for Thoracic Surgery database or via patient report during follow up phone calls.
Outcome Time Frame
30 days postoperatively
Outcome Measure
Readmission
Outcome Description
Major cardiac events will be evaluated within 30 days postoperatively and include stroke, atrial fibrillation and renal failure. These outcomes will be assessed using the Society for Thoracic Surgery database and medical record review.
Outcome Time Frame
30 days postoperatively
Outcome Measure
Inpatient Morbidity
Outcome Description
All-cause mortality will be assessed in-hospital and at 30, 180 and 365 days postoperatively. Mortality will be assessed using a combination of electronic medical record review, Society for Thoracic Surgery database, and family report during the follow up phone calls.
Outcome Time Frame
Postoperatively until discharge, an average of six days, and at 30, 180 and 365 days postoperatively
Outcome Measure
Mortality
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
60
Investigators
Investigator Type
Principal Investigator
Investigator Name
Matthias Eikermann
Investigator Email
meikermann@montefiore.org
Investigator Department
Anesthesiology
Study Department
Anesthesiology
Study Division
Please Specify
Categories Mesh Debug
Mental Health & Behavioral Research --- DELIRIUM
Mental Health & Behavioral Research --- CONFUSION
Mental Health & Behavioral Research --- NEUROBEHAVIORAL MANIFESTATIONS
Brain, Spinal Cord & Nervous System --- NEUROLOGIC MANIFESTATIONS
Headaches & Migraine --- NEUROLOGIC MANIFESTATIONS
Substance Use and Addiction --- NEUROLOGIC MANIFESTATIONS
Brain, Spinal Cord & Nervous System --- NERVOUS SYSTEM DISEASES
Brain, Spine & Nerve Cancers --- NERVOUS SYSTEM DISEASES
Alzheimer's --- NEUROCOGNITIVE DISORDERS
Child Development & Autism --- MENTAL DISORDERS
Mental Health & Behavioral Research --- MENTAL DISORDERS
Psychiatry & Behavioral Sciences --- MENTAL DISORDERS
Substance Use and Addiction --- MENTAL DISORDERS
MeSH Terms
DELIRIUM
CONFUSION
NEUROBEHAVIORAL MANIFESTATIONS
NEUROLOGIC MANIFESTATIONS
NERVOUS SYSTEM DISEASES
SIGNS AND SYMPTOMS
PATHOLOGICAL CONDITIONS, SIGNS AND SYMPTOMS
NEUROCOGNITIVE DISORDERS
MENTAL DISORDERS