Early Norepinephrine in Trauma Patients With Hemorrhagic Shock

PHASE1/PHASE2Enrolling by invitationINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

May 20, 2025

Primary Completion Date

July 17, 2027

Study Completion Date

August 18, 2027

Conditions
Trauma, Multiple
Interventions
DRUG

Norepinephrine

Norepinephrine bitartrate (LEVOPHEDR, Pfizer inc.) 4 mg/4ml + 5% Dextrose in water 246 ml (total volume 250 ml, final concentration 16 mcg/ml) infuses intravenously via a central catheter or peripheral line with the rate of 10 ml/h (equivalent to 0.05 mcg/kg/min for a 50-kg patient). The drug will be initiated within 1 hour after randomization, infused for 24 hours after randomization, and then discontinued.

DRUG

Placebo

5% Dextrose in water 250 ml infused intravenously at a rate of 10 ml/h. The drug will be initiated within 1 hour after randomization, infused for 24 hours after randomization, and then discontinued.

Trial Locations (2)

10400

Faculty of Medicine Ramathibodi Hospital, Bangkok

10700

Faculty of Medicine Siriraj Hospital, Bangkok

All Listed Sponsors
collaborator

Siriraj Hospital

OTHER

lead

Visarat Palitnonkiat

OTHER