Effects of Perioperative Nesiritide or Milrinone Infusion on Recovery From Fontan Surgery

What Was Tested

In this phase 2 trial, researchers set out to test BNP (Nesiritide).

In this procedure, systemic venous return is rerouted directly to the pulmonary arteries, which serves to separate the systemic and pulmonary circulations.

It had three arms (groups): I- nesiritide (experimental), II- Milrinone (active comparator) and III- placebo (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

Following this operation, deoxygenated blood flows passively from the body through the lungs without a pumping chamber.

The researchers propose a single-center, randomized, double-blind, phase II clinical trial in children undergoing Fontan surgery.

The researchers plan to compare the effects of perioperative nesiritide, milrinone and placebo infusions on the early postoperative clinical course and neurohumoral profile.

The researchers hypothesize that, when compared to the milrinone and placebo groups, the nesiritide group will have more days alive and out of the hospital within the first 30 days after surgery.

Who Took Part

The registry lists 106 actual participants took part.

It was open to people of any sex.

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

Examples of who could join: Patients undergoing an elective, primary Fontan operation at Children's Hospital Boston.

The full record lists 1 inclusion and 3 exclusion criteria; among the exclusions: revision surgery for failing fontan circulation; the attending surgeon, cardiac anesthesiologist, or cardiac intensivist has a compelling indication to initiate either nesiritide or milrinone outside of the confines of the study.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

The participants were allocated by chance, so the BNP (Nesiritide) group and the comparison group should start out alike.

The BNP (Nesiritide) group and the comparison group ran side by side rather than switching.

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

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

It started in 2007-10 with completion listed for 2013-01.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Days Alive and Out of the Hospital Within 30 Days of Surgery (time frame: 30 days).

It also tracked 14 secondary outcomes, for example Cardiovascular: Cardiac Index, Cardiovascular: Cardiac Index, Cardiovascular: Arrhythmia, Cardiovascular: Peak Inotrope Score, Cardiovascular: Peak Lactate Level and Renal Function: Urine Output.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of BNP (Nesiritide) in 106 people.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

More context: the BNP (Nesiritide) compound page, all human trials.