Use of Vasopressin Following the Fontan Operation

What Was Tested

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

It had two arms (groups): Vasopressin (experimental) and Normal saline (placebo comparator).

Normal saline will be provided on a drip infusion to the selected group once coming off cardiopulmonary bypass following the Fontan operation.

The registry classes the interventions as drug.

More on the Plan

A pilot randomized, double blinded clinical trial to evaluate the use of vasopressin following the Fontan operation.

Phase one of the study will be a single center pilot study and will be conducted at Advocate Children's Hospital, Oak Lawn IL.

This will be a randomized and double blinded.

Ten patients will be enrolled with five patients as control group and five receiving Vasopressin.

Who Took Part

12 actual participants took part.

It was open to people of any sex aged from 18 months up to 7 years.

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

Examples of who could join: Subjects between 1.5-7 years old undergoing Fontan operation.

The full record lists 1 inclusion and 4 exclusion criteria; among the exclusions: patients with a planned fenestrated fontan; patients undergoing revision surgery for failing fontan; planned arch reconstruction at the time of the fontan procedure.

How the Study Was Run

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

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

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

Neither the participants nor the staff measuring them knew who was on Vasopressin, so expectations could not easily colour the readings.

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

It started in 2016-12 with completion listed for 2019-12.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Chest Tube Drainage (time frame: From post operative day 0 through study completion, an average of 1 month).

It also tracked 1 secondary outcome, for example Length of Hospital Stay.

What This Means in Plain Language

Put simply, this is a phase 2, phase 3, randomized trial of Vasopressin in 12 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.