Intravenous AII for the Treatment of Severe Hypotension in High Output Shock: A Pilot Study

PHASE1CompletedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

July 31, 2011

Primary Completion Date

January 31, 2014

Study Completion Date

January 31, 2014

Conditions
Septic Shock
Interventions
DRUG

Angiotensin II

All patients will have their vasopressors titrated to a mean arterial pressure (MAP) of 65 mm of Hg (standard MAP goal in the ICU for patients suffering from shock). Patients will then be randomized to control or IV AII. In the interventional arm, AII will start at a dose of 20ng/kg/min; the dose can then be titrated up to 30ng/kg/min, and then to 40ng/kg/min. The intervention will last for 6 hours. Each patient will start with the assigned starting dose indicated above. After the first hour, if the patient is still requiring standing norepinephrine (the standard vasopressor for the treatment of shock in the GW ICU), the dose of the control/interventional drug can be increased 50%. After the second hour, if the patient is still requiring a standing dose of norepinephrine, the control/interventional can be increased again to twice the initial dose. At the end of 6 hours, the study drug will be titrated off.

Trial Locations (1)

20037

GW University, Washington D.C.

All Listed Sponsors
lead

George Washington University

OTHER

NCT01393782 - Intravenous AII for the Treatment of Severe Hypotension in High Output Shock: A Pilot Study | Biotech Hunter | Biotech Hunter