Early Use of Vasopressin in Post-Fontan Management

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

March 6, 2017

Primary Completion Date

November 1, 2018

Study Completion Date

January 28, 2019

Conditions
Circulatory Perfusion DisorderCongenital Heart DiseaseSingle-ventricle
Interventions
DRUG

Vasopressin, Arginine

Subjects will be started on a blinded continuous infusion of study drug/placebo in the OR, immediately following the completion of the MUF at 0.3 mU/kg/min. All caregivers will be blinded to the arm assignment. The infusion will run for 20 hours, at which time it will be weaned off at 0.1 mU/hr, over 3 hours.During the active study period, the care team will treat subjects per SOC, using any preferred medication to correct low cardiac output; there is no restriction on using open-label vasopressin during the active study treatment period.

DRUG

Placebo

Subjects will be started on a blinded continuous infusion of study drug/placebo in the OR, immediately following the completion of the MUF at 0.3 mU/kg/min. All caregivers will be blinded to the arm assignment. The infusion will run for 20 hours, at which time it will be weaned off at 0.1 mU/hr, over 3 hours.During the active study period, the care team will treat subjects per SOC, using any preferred medication to correct low cardiac output; there is no restriction on using open-label vasopressin during the active study treatment period.

Trial Locations (1)

53226

Children's Hospital of Wisconsin, Milwaukee

All Listed Sponsors
lead

Medical College of Wisconsin

OTHER

NCT03088345 - Early Use of Vasopressin in Post-Fontan Management | Biotech Hunter | Biotech Hunter