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

Delirium Clinical Trial

— MINDDS II  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06192615
• Other study ID #: 2023P00359
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: April 1, 2024
• Est. completion date: March 31, 2029

Study information

• Verified date: December 2023
• Source: Massachusetts General Hospital
• Contact: Oluwaseun Johnson-Akeju, MD
• Phone: 617-726-3030
• Email: ojohnsonakeju[@]partners.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1800
• Est. completion date: March 31, 2029
• Est. primary completion date: October 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Delirium

Intervention

Drug:
• Intravenous Dexmedetomidine
Intravenous dexmedetomidine (1 µg/kg over 40 minutes, a maximal dose of 80 µg)
• Sublingual Dexmedetomidine
Sublingual dexmedetomidine (120 µg)
• Intravenous Placebo
Intravenous placebo of 0.9% saline administered over 40 minutes
• Sublingual Placebo
Inert sublingual film

Locations

Country	Name	City	State
United States	University of Maryland School of Medicine	Baltimore	Maryland
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Montefiore Medical Center	Bronx	New York
United States	Northwestern University Feinberg School of Medicine	Chicago	Illinois
United States	Duke University Hospital	Durham	North Carolina
United States	University of Iowa Carver College of Medicine	Iowa City	Iowa
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Columbia University Medical Center	New York	New York
United States	University of Nebraska Medical Center	Omaha	Nebraska
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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.	Postoperative Day 1 to Day 7
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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