Phase 3 N=20 Randomized Quadruple-blind Treatment

Early Use of Vasopressin in Post-Fontan Management

Circulatory Perfusion Disorder · Congenital Heart Disease · Single-ventricle

Bottom Line

View on ClinicalTrials.gov: NCT03088345 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2020

Primary outcome: Primary: Hemodynamics as Characterized by Vasoactive Inotrope Score (VIS) — 11; 11.3 units

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Vasopressin, Arginine (Drug); Placebo (Drug)
Age: Pediatric, Adult · 0+ yrs
Sex: All
Sponsor: Medical College of Wisconsin
Primary completion: Nov 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Hemodynamics as Characterized by Vasoactive Inotrope Score (VIS)	11; 11.3	—
PRIMARY Hemodynamics as Characterized by Mean Arterial Pressure	67; 66	—
PRIMARY Hemodynamics as Characterized by Transpulmonary Pressure Gradient	6.4; 8.3	—
SECONDARY Renal Dysfunction as Characterized by Change in Cystatin Level	0.095; 0.017	—
SECONDARY Liver Dysfunction as Characterized by Transaminase Levels	715; 522	—

Summary

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.

Eligibility Criteria

Inclusion Criteria

Planned completion of Fontan palliation
English or Spanish speaking
Completion of Informed Consent

Exclusion Criteria

Previous failed attempts at Fontan completion with subsequent takedown
Planned concomitant atrioventricular valvuloplasty or neoaortic valve or arch reconstruction at the time of Fontan completion
History of renal failure requiring renal replacement therapy
Absence of informed consent

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03088345). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.