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Trial record 49 of 122 for:    Behaviors and Mental Disorders[CONDITION-BROWSE-BRANCH] | Recruiting, Not yet recruiting, Available Studies | ( Map: Massachusetts, United States ) | NIH, U.S. Fed

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 : January 8, 2019
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Oluwaseun Johnson-Akeju, MD, MMSc, Massachusetts General Hospital

Brief Summary:
This study aims to determine whether, compared with placebo, the nighttime administration of a intravenous dexmedetomidine is effective at inducing sleep and preventing postoperative delirium in extubated post-cardiac surgical patients.

Condition or disease Intervention/treatment Phase
Postoperative Delirium Sleep Anesthesia Drug: Dexmedetomidine Drug: Placebo Phase 2 Phase 3

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 370 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium

Arm Intervention/treatment
Experimental: Dexmedetomidine-induced sleep
Precedex (Dexmedetomidine) intervention: Intravenous administration of 1mcg/kg over 40 minutes.
Drug: Dexmedetomidine
Dexmedetomidine
Other Name: Precedex

Placebo Comparator: Placebo
Placebo of normal saline: Intravenous administration of normal saline over 40 minutes.
Drug: Placebo
Placebo
Other Name: Normal Saline




Primary Outcome Measures :
  1. Incidence of delirium [ Time Frame: Post operative day 1 (24 hours) ]
    Confusion Assessment Method


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. Postoperative Cognitive Status [ Time Frame: 30 days, 90 days, and 180 days postoperatively ]
    Telephone Montreal Cognitive Assessment

  5. Postoperative health related quality of life [ Time Frame: 30 days, 90 days, and 180 days postoperatively ]
    PROMIS-29 questionnaires


Other Outcome Measures:
  1. Length of Hospital Stay [ Time Frame: from postoperative day 0 until date of hospital discharge (no prespecified length possible) ]
    Medical Record Review



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age ≥ 60
  • Scheduled for a cardiac surgical procedure with planned post-operative admission to the CSICU for ≥ 24 hours
  • Scheduled same day surgical admission

Exclusion Criteria:

  • Blind, deafness or the inability to speak English
  • Greater than 2 days of ICU admission in the month preceding the current surgical procedure
  • Renal and liver failure requiring dialysis or Child-Pugh score > 5
  • Follow-up difficulties (i.e. active substance abuse, psychotic disorder, homelessness)
  • Previous cardiac surgery within 1 year of surgical procedure
  • Allergy to dexmedetomidine
  • Chronic therapy with benzodiazepines and/or antipsychotics
  • Severe deficit due to structural or anoxic brain damage
  • Surgical procedure requiring total circulatory arrest

Objective Drop Criteria

  • Scheduled for a second surgical procedure during hospital stay
  • Post-operative intubation > 12 hours

Information from the National Library of Medicine

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


Contacts
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Contact: Oluwaseun Akeju 6176972824 oluwaseun.akeju@mgh.harvard.edu

Locations
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United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Oluwaseun Johnson-Akeju, M.D.,M.M.Sc.    617-724-7200    ojohnsonakeju@partners.org   
Principal Investigator: Oluwaseun Johnson-Akeju, M.D.,M.M.Sc.         
Sponsors and Collaborators
Massachusetts General Hospital
National Institute on Aging (NIA)

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Oluwaseun Johnson-Akeju, MD, MMSc, Assistant Professor in Anesthesia, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02856594     History of Changes
Other Study ID Numbers: 2016P000742
1R01AG053582 ( U.S. NIH Grant/Contract )
First Posted: August 5, 2016    Key Record Dates
Last Update Posted: January 8, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Dexmedetomidine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action