Phase 3
Completed N=20
Early Use of Vasopressin in Post-Fontan Management
Circulatory Perfusion Disorder · Heart Failure · Single-ventricle
Source: ClinicalTrials.gov NCT03088345 ↗
Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Jul 2020
Primary outcomePrimary: Hemodynamics as Characterized by Vasoactive Inotrope Score (VIS) — 11; 11.3 units
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
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 | — |
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
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. Informational only — not medical advice.