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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Massachusetts General Hospital
Study ID
NCT06192615
Phase
PHASE3
Status
Recruiting
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Conditions

  • Delirium

Eligibility Criteria

Sex
ALL
Age
60 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jan 6, 2025
Status verified
Jan 2025
Primary completion
Oct 31, 2027
Completion
Mar 31, 2029

Study Design

Enrollment
1,800 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Intravenous Dexmedetomidine
    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.
  • Experimental: Sublingual Dexmedetomidine
    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.
  • Placebo Comparator: Placebo
    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.

Primary Outcome Measure

Delirium [ Time Frame: Postoperative day 1 ]

Central Contacts

Locations (14)

FacilityCityStateZIPSite coordinators
Cedars-Sinai Medical CenterLos AngelesCalifornia90048
Abirami Kumaresan, MD
University of California San FranciscoSan FranciscoCalifornia94117
Matthieu Legrand, MD
Northwestern University Feinberg School of MedicineChicagoIllinois60611
Charles Hogue, MD
University of Iowa Carver College of MedicineIowa CityIowa522421320
Andrew Feider, MD
University of Maryland School of MedicineBaltimoreMaryland21201
Patrick Odonkor, MD
Beth Israel Deaconess Medical CenterBostonMassachusetts02215
Shahzad Shaefi, MD
Brigham and Women's HospitalBostonMassachusetts02215
Oluwaseun Johnson-Akeju, MD
Massachusetts General HospitalBostonMassachusetts02114
Amit Bardia, MD
Washington University School of MedicineSt LouisMissouri63110
Ben Palanca, MD
University of Nebraska Medical CenterOmahaNebraska68198
Shaun Thompson, MD
Columbia University Medical CenterNew YorkNew York10032
Vivek Moitra, MD
Montefiore Medical CenterThe BronxNew York10467
Matthias Eikermann, MD
Duke University HospitalDurhamNorth Carolina27710
Mihai Podgoreanu, MD
Vanderbilt University Medical CenterNashvilleTennessee37232
Frederic T Billings, MD

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By research site
Cedars-Sinai Medical Center· Los Angeles, CAUniversity of California San Francisco· San Francisco, CANorthwestern University Feinberg School of Medicine· Chicago, ILUniversity of Iowa Carver College of Medicine· Iowa City, IAUniversity of Maryland School of Medicine· Baltimore, MDBeth Israel Deaconess Medical Center· Boston, MA

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