The MENDS2 Study, Maximizing the Efficacy of Sedation and Reducing Neurological Dysfunction and Mortality in Septic Patients With Acute Respiratory Failure

PHASE3CompletedINTERVENTIONAL
Enrollment

438

Participants

Timeline

Start Date

May 15, 2013

Primary Completion Date

July 31, 2019

Study Completion Date

July 31, 2019

Conditions
SepsisDeliriumImpaired Cognition
Interventions
DRUG

Dexmedetomidine

For patients in the dexmedetomidine group, dose will range from 0.15-1.5 mcg/kg/hr. For example, a 70 kg patient would receive 10.5 mL of study drug per hour, which would provide 0.75 mcg/kg/hr of dexmedetomidine. This dose range have been selected after literature review and discussions with critical care practitioners, investigational pharmacists, and the MENDS2 study steering committee.

DRUG

Propofol

For patients in the propofol group, dose will range from 5-50 mcg/kg/min. For example, a 70 kg patient would receive 10.5 mL of study drug per hour, which would provide 25 mcg/kg/min of propofol. This dose range has been selected after literature review and discussions with critical care practitioners, investigational pharmacists, and the MENDS2 study steering committee.

Trial Locations (11)

28801

Mission Hospital, Asheville

53706

University of Wisconsin, Madison

70806

Baton Rouge General Medical Center and Our Lady of The Lakes Regional Medical Center, Baton Rouge

76104

Texas Health Harris Fort Worth, Fort Worth

77030

Houston Methodist Hospital, Houston

78229

University of Texas Health Science Center at San Antonio, San Antonio

94143

University of California, San Francisco, San Francisco

02111

Tufts Medical Center, Boston

01107

Baystate Medical Center, Springfield

37232-8300

Vanderbilt University Medical Center, Nashville

77030-3411

Baylor College of Medicine, Houston

All Listed Sponsors
lead

Vanderbilt University Medical Center

OTHER

NCT01739933 - The MENDS2 Study, Maximizing the Efficacy of Sedation and Reducing Neurological Dysfunction and Mortality in Septic Patients With Acute Respiratory Failure | Biotech Hunter | Biotech Hunter