Minimizing ICU Neurological Dysfunction With Dexmedetomidine-induced Sleep (MINDDS)
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|ClinicalTrials.gov Identifier: NCT02856594|
Recruitment Status : Recruiting
First Posted : August 5, 2016
Last Update Posted : August 6, 2019
|Condition or disease||Intervention/treatment||Phase|
|Postoperative Delirium Sleep Anesthesia||Drug: Dexmedetomidine Drug: Placebo||Phase 2 Phase 3|
Delirium is an acute brain dysfunction characterized by disturbances in attention, awareness, and cognition not explained by a preexisting neurocognitive disorder. Although the increased mortality rates ascribed to delirium remain debatable, delirium remains a leading cause of preventable morbidity in hospitalized elderly patients. It is also associated with prolonged hospitalization, prolonged institutionalization, and long-term cognitive deficits. Patients with pre-existing dementia, such as Alzheimer's disease, are especially vulnerable to developing delirium. The total healthcare cost attributable to delirium is estimated between $143 and $152 billion annually. In the United States, delirium occurs in approximately 80% of critically ill patients admitted to medical/surgical intensive care units (ICU), and 15% of patients admitted to cardiac surgical (CS) ICU. Most patients diagnosed with delirium also present with multiple comorbidities (sepsis, multi-organ failure) that significantly confound our understanding of this disease. Thus, to date, no pharmacological intervention to treat delirium has been identified.
There is mounting evidence to suggest that sleep deprivation may be a modifiable risk factor for the development of delirium. Presently, pharmacological treatment with no current medication (benzodiazepines, antipsychotics) induces natural sleep or reliably reduces the incidence of delirium. The investigators have found that biomimetic sleep, defined here as pharmacological induction of rapid eye movement sleep (REM) and non-REM (N1, N2, N3) sleep states using dexmedetomidine, can now be achieved in humans. The overall objective of this study is to evaluate the efficacy of biomimetic sleep in reducing the incidence and severity of delirium in extubated CSICU patients. The investigators will also assess for peri-operative electroencephalogram biomarkers of delirium, and the association between delirium and chronic neuroinflammation using positron emission tomography. The MINDDS study is poised to enable therapeutic and diagnostic discoveries to aid the care of elderly patients who are at risk for developing postoperative delirium.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||370 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Minimizing ICU Neurological Dysfunction With Dexmedetomidine-induced Sleep (MINDDS): A Randomized Placebo-controlled Trial|
|Actual Study Start Date :||March 6, 2017|
|Estimated Primary Completion Date :||February 2021|
|Estimated Study Completion Date :||September 2021|
Experimental: Dexmedetomidine-induced sleep
Precedex (Dexmedetomidine) intervention: Intravenous administration of 1mcg/kg over 40 minutes.
Other Name: Precedex
Placebo Comparator: Placebo
Placebo of normal saline: Intravenous administration of normal saline over 40 minutes.
Other Name: Normal Saline
- Incidence of delirium [ Time Frame: Post operative day 1 (24 hours) ]Confusion Assessment Method
- ICU delirium/coma-free days [ Time Frame: Up until postoperative day 3, or up until postoperative day 7 or discharge for patients who are delirious beyond postoperative day 5 ]Confusion Assessment Method
- Severity of Delirium [ Time Frame: Up until postoperative day 3, or up until postoperative day 7 or discharge for patients who are delirious beyond postoperative day 5 ]Confusion Assessment Method
- 30-day, 90-day, and 180-day mortality [ Time Frame: Up to postoperative day 180 (6 months) ]30-day, 90-day, and 180-day mortality
- Postoperative Cognitive Status [ Time Frame: 30 days, 90 days, and 180 days postoperatively ]Telephone Montreal Cognitive Assessment
- Postoperative health related quality of life [ Time Frame: 30 days, 90 days, and 180 days postoperatively ]PROMIS-29 questionnaires
- Length of Hospital Stay [ Time Frame: from postoperative day 0 until date of hospital discharge (no prespecified length possible) ]Medical Record Review
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02856594
|Contact: Oluwaseun Akejufirstname.lastname@example.org|
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Oluwaseun Johnson-Akeju, M.D.,M.M.Sc. 617-724-7200 email@example.com|
|Principal Investigator: Oluwaseun Johnson-Akeju, M.D.,M.M.Sc.|