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

PHASE3RecruitingINTERVENTIONAL
Enrollment

1,800

Participants

Timeline

Start Date

January 6, 2025

Primary Completion Date

October 31, 2027

Study Completion Date

March 31, 2029

Conditions
Delirium
Interventions
DRUG

Intravenous Dexmedetomidine

Intravenous dexmedetomidine (1 μg/kg over 40 minutes, a maximal dose of 80 μg)

DRUG

Sublingual Dexmedetomidine

Sublingual dexmedetomidine (120 μg)

DRUG

Intravenous Placebo

Intravenous placebo of 0.9% saline administered over 40 minutes

DRUG

Sublingual Placebo

Inert sublingual film

Trial Locations (12)

10032

NOT_YET_RECRUITING

Columbia University Medical Center, New York

10467

NOT_YET_RECRUITING

Montefiore Medical Center, The Bronx

21201

NOT_YET_RECRUITING

University of Maryland School of Medicine, Baltimore

27710

NOT_YET_RECRUITING

Duke University Hospital, Durham

37232

NOT_YET_RECRUITING

Vanderbilt University Medical Center, Nashville

60611

NOT_YET_RECRUITING

Northwestern University Feinberg School of Medicine, Chicago

63110

NOT_YET_RECRUITING

Washington University School of Medicine, St Louis

68198

NOT_YET_RECRUITING

University of Nebraska Medical Center, Omaha

522421320

NOT_YET_RECRUITING

University of Iowa Carver College of Medicine, Iowa City

02114

RECRUITING

Massachusetts General Hospital, Boston

02215

NOT_YET_RECRUITING

Beth Israel Deaconess Medical Center, Boston

NOT_YET_RECRUITING

Brigham and Women's Hospital, Boston

All Listed Sponsors
lead

Massachusetts General Hospital

OTHER