Adults 3 Weeks to 18, any sex, with Circulatory Perfusion Disorder or Congenital Heart Disease. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Hemodynamics as Characterized by Vasoactive Inotrope Score (VIS)Primary· 48 hours post-operative
The vasoactive inotrope score (VIS) is a linear sum of vasoactive and inotrope durg infusion doses. It is usually reported as dimensionless but is sometimes reported as normalized to dopamine mcg/kg/min equivalents. The score starts at 0 and has no defined upper limit, with a commonly observed range 0-50. It is used as a measure of the intensity of hemodynamic support, with higher scores indicating more vasoactive drug support for patients. The relationship of VIS to other patient outcomes is not consistent. It will be calculated hourly for all subjects and compared between groups over the ent
Group
Value
95% CI
Vasopressin, Arginine
11
± 1.6
Placebo
11.3
± 1.9
Hemodynamics as Characterized by Mean Arterial PressurePrimary· 24 hours post-operative
Organ perfusion pressure measured as Mean Arterial Pressure (MAP). It will be measured hourly for 24 postoperative hours for all subjects and compared between the two study groups over the whole time of observation as the main between-group effect in panel regression.
Group
Value
95% CI
Vasopressin, Arginine
67
± 1.3
Placebo
66
± 1.1
Hemodynamics as Characterized by Transpulmonary Pressure GradientPrimary· 24 hours post-operative
The transpulmonary pressure gradient (TPG), defined as the difference between mean pulmonary arterial pressure (Ppa) and left/common atrial (common atrial) pressure (Pla) will be measured hourly for 24 postoperative hours for all subjects and compared between the two study groups over the whole time of observation as the main between-group effect in panel regression.
Group
Value
95% CI
Vasopressin, Arginine
6.4
± 0.5
Placebo
8.3
± 0.5
Renal Dysfunction as Characterized by Change in Cystatin LevelSecondary· from baseline pre-cardiopulmonary bypass to 24 hours post-operative
Cystatin levels will be measured at baseline (immediately before cardiopulmonary bypass) 24 hours postoperative. The change (postoperative minus baseline) in cystatin level will be compared between groups.
Group
Value
95% CI
Vasopressin, Arginine
0.095
-0.086 – 0.277
Placebo
0.017
-0.160 – 0.194
Liver Dysfunction as Characterized by Transaminase LevelsSecondary· 48 hours post-operative
Transaminase levels (alanine and aspartate, measured in IU/L ) will be tracked for all patients and changes will be compared between study groups.
Group
Value
95% CI
Vasopressin, Arginine
715
± 653
Placebo
522
± 397
Resource Utilization Measured by Length of Stay (LOS)Secondary· from time of operation until hospital discharge
Length of stay (LOS) measured in postoperative hours compared between groups
Group
Value
95% CI
Vasopressin, Arginine
180
± 72
Placebo
203
± 72
Sponsor's own description
This is an investigator initiated, prospective, single-center, double-blinded, randomized, placebo-controlled trial of post-operative low dose vasopressin infusions as an early treatment of low systemic perfusion in pediatric patients following Fontan palliation.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Medical College of Wisconsin
Last refreshed: 7 July 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03088345.