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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravenous Dexmedetomidine | Experimental | 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. |
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| Sublingual Dexmedetomidine | Experimental | 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. |
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| Placebo | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravenous Dexmedetomidine | Drug | Intravenous dexmedetomidine (1 μg/kg over 40 minutes, a maximal dose of 80 μg) |
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| Measure | Description | Time Frame |
|---|---|---|
| Delirium | 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. | Postoperative day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Delirium | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Oluwaseun Johnson-Akeju, MD | Contact | 617-726-3030 | ojohnsonakeju@partners.org | |
| Ariel Mueller, MA | Contact | 6177269252 | almueller@mgh.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Oluwaseun Johnson-Akeju, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Medical Center | Not yet recruiting | Los Angeles | California | 90048 | United States |
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| Sublingual Dexmedetomidine | Drug | Sublingual dexmedetomidine (120 μg) |
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| Intravenous Placebo | Drug | Intravenous placebo of 0.9% saline administered over 40 minutes |
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| Sublingual Placebo | Drug | Inert sublingual film |
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| Postoperative Day 1 to Day 7 |
| Delirium Severity | 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. | Postoperative day 1 to day 7 |
| Telephonic Montreal Cognitive Assessment | 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. | 30, 180 and 365 days |
| Global Health | 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. | 30, 180 and 365 days |
| Pain at Rest and Upon Exertion | 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. | Postoperative day 1 to day 7 |
| Opioid and Analgesic Administration | 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. | 48 hours postoperatively |
| Hospital Length of Stay | Hospital length of stay will be defined as the number of days after surgery until the time of discharge from the hospital. | Postoperatively until discharge, an average of six days |
| Intensive Care Unit Length of Stay | 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. | Postoperatively until discharge, an average of 24 hours |
| Readmission | 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. | 30 days postoperatively |
| Inpatient Morbidity | 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. | 30 days postoperatively |
| Mortality | 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. | Postoperatively until discharge, an average of six days, and at 30, 180 and 365 days postoperatively |
| University of California San Francisco | Not yet recruiting | San Francisco | California | 94117 | United States |
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| Northwestern University Feinberg School of Medicine | Recruiting | Chicago | Illinois | 60611 | United States |
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| University of Iowa Carver College of Medicine | Recruiting | Iowa City | Iowa | 522421320 | United States |
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| University of Maryland School of Medicine | Recruiting | Baltimore | Maryland | 21201 | United States |
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| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States |
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| Beth Israel Deaconess Medical Center | Recruiting | Boston | Massachusetts | 02215 | United States |
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| Brigham and Women's Hospital | Recruiting | Boston | Massachusetts | 02215 | United States |
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| Washington University School of Medicine | Not yet recruiting | St Louis | Missouri | 63110 | United States |
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| University of Nebraska Medical Center | Recruiting | Omaha | Nebraska | 68198 | United States |
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| Columbia University Medical Center | Recruiting | New York | New York | 10032 | United States |
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| Montefiore Medical Center | Not yet recruiting | The Bronx | New York | 10467 | United States |
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| Duke University Hospital | Recruiting | Durham | North Carolina | 27710 | United States |
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| Vanderbilt University Medical Center | Recruiting | Nashville | Tennessee | 37232 | United States |
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| ID | Term |
|---|---|
| D003693 | Delirium |
| ID | Term |
|---|---|
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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