CompletedPhase 2/3

Early Use of Vasopressin in Post-Fontan Management

United States20 participantsStarted 2017-03-06

Plain-language 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.

Who can participate

Age range3 Weeks – 18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Hemodynamics as Characterized by Vasoactive Inotrope Score (VIS)

Timeframe: 48 hours post-operative

Hemodynamics as Characterized by Mean Arterial Pressure

Timeframe: 24 hours post-operative

Hemodynamics as Characterized by Transpulmonary Pressure Gradient

Timeframe: 24 hours post-operative

Trial details

NCT IDNCT03088345

SponsorMedical College of Wisconsin

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-11-01

Results submitted2020-05-11

View on ClinicalTrials.gov More Circulatory Perfusion Disorder trials