Early Use of Vasopressin in Post-Fontan Management

What Was Tested

The trial (phase 2, phase 3) is built around Vasopressin.

It had two arms (groups): Vasopressin, Arginine (experimental) and Placebo (placebo comparator).

Patients randomized to this arm will receive a continuous arginine vasopressin in normal saline carrier infusion immediately following the modified ultrafiltration (MUF) period of their cardiac surgery.

Patients randomized to this arm will receive a continuous normal saline carrier infusion immediately following the modified ultrafiltration (MUF) period of their cardiac surgery.

The registry classes the interventions as drug.

More on the Plan

It is a common institutional practice to use vasopressin in this patient population, but usually after escalation through two or three other vasoactive drugs.

The investigators propose to randomize the use of vasopressin to use at an earlier point in their typical post-operative medication strategy.

The proposed study is a double blinded, randomized, placebo control study of vasopressin infusion immediately after the completion Fontan operation.

There are no established guidelines for managing patients after congenital heart surgery due to lesion-specific unique challenges in the post-operative period.

Who Took Part

20 actual participants took part.

It was open to people of any sex aged from 3 Weeks up to 18 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Planned completion of Fontan palliation. English or Spanish speaking. Completion of Informed Consent.

The full record lists 3 inclusion and 4 exclusion criteria; among the exclusions: 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.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

The participants were allocated by chance, so the Vasopressin group and the comparison group should start out alike.

The Vasopressin group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the participants and researchers unaware of who received Vasopressin.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2017-03-06 with completion listed for 2018-11-01.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Hemodynamics as Characterized by Vasoactive Inotrope Score (VIS) (time frame: 48 hours post-operative). Hemodynamics as Characterized by Mean Arterial Pressure (time frame: 24 hours post-operative). Hemodynamics as Characterized by Transpulmonary Pressure Gradient (time frame: 24 hours post-operative).

It also tracked 2 secondary outcomes, for example Renal Dysfunction as Characterized by Change in Cystatin Level and Liver Dysfunction as Characterized by Transaminase Levels.

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of Vasopressin in 20 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Vasopressin compound page, all human trials.