Safety and Efficacy of Vasopressin After Fontan Completion: A Randomized Pilot Study

What Was Tested

Researchers studied Vasopressin in this randomized controlled trial publication.

Arginine vasopressin is a nonapeptide hormone with effects on intracellular water transport and arterial tone that is used in distributive shock and following cardiopulmonary bypass.

Who Took Part

PubMed indexes the participants as young children, both men and women.

Patient characteristics, hospital outcomes, and measures of hemodynamic parameters, urine output, chest tube drainage, fluid balance, laboratory data, and plasma arginine vasopressin concentrations were collected at baseline and for 48 postoperative hours.

How the Study Was Run

In design terms this was a randomized, double-blind, placebo-controlled and pilot study.

Random assignment meant chance, not the researchers, decided who got Vasopressin and who got the comparison, which limits bias.

As a double-blind Vasopressin study, the assignments were hidden from both participants and investigators until the end.

The comparison arm used a placebo, so changes seen with Vasopressin could be set against what happens without it.

It is described as a pilot, a small early test of whether a larger Vasopressin study would be practical.

The researchers conducted a randomized, double-blinded, placebo-controlled study of vasopressin infusion for 24 hours after cardiopulmonary bypass for Fontan completion.

Data were analyzed using mixed-effect regressions.

What Was Measured

Topics PubMed links to this paper include Antidiuretic Agents, Fontan Procedure, Heart Defects, Congenital, Incidence, Pilot Projects, Postoperative Care and Postoperative Complications.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Vasopressin.

Results are reported in around 6 sentences of the abstract; we leave them to the paper itself rather than summarise them.

The publication is from 2019 (The Annals of thoracic surgery), a journal based in Netherlands.

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