Dexmedetomidine to Lessen Intensive Care Unit (ICU) Agitation

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

96

Participants

Timeline

Start Date

February 28, 2011

Primary Completion Date

December 31, 2013

Study Completion Date

December 31, 2013

Conditions
Delirium
Interventions
DRUG

Dexmedetomidine

"Dexmedetomidine will be administered intravenously as a maintenance infusion of 0.2 to 1.5 mcg/kg/hour, commencing at 0.5 mcg/kg/hour and titrated according to effect, for as long as deemed necessary by the treating physician. Specifically, the study medication may be (as recommended by the manufacturer) continued after extubation, and if discontinued may be restarted at any time up until ICU discharge. The clinician will have the option of using a loading dose of 1.0 mcg/kg IV over 20 minutes, as recommended by the manufacturer.~Bedside nursing staff will adjust drug infusion rates as necessary, in consultation with the treating physician, aiming to achieve a Riker Sedation-Agitation Scale 20 score of 4."

DRUG

Saline placebo

An identical syringe containing only saline with no dexmedetomidine added will be supplied. Initial rate of infusion and subsequent adjustments will be the same as in the active comparator group.

Trial Locations (7)

2065

Royal North Shore Hospital, St Leonards

3011

The Western Hospital, Footscray

3076

Northern Hospital, Epping

3084

Austin Hospital, Melbourne

3181

The Alfred Hospital, Prahran

4350

Toowoomba Hospital, Toowoomba

6001

Royal Perth Hospital, Perth

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Hospira, now a wholly owned subsidiary of Pfizer

INDUSTRY

lead

Austin Health

OTHER_GOV