Impact of Nesiritide on Early Postoperative Recovery After Total Cavo-Pulmonary Connection Surgery in Children

What Was Tested

In this not phased trial, researchers set out to test BNP (Nesiritide).

Nesiritide, a recombinant human B-type natriuretic peptide, has favorable effects on patient symptoms, hemodynamics, and the neurohumoral profile in adults with decompensated congestive heart failure and in those recovering from cardiac surgery involving cardiopulmonary bypass.

It had two arms (groups): Intervention-Nesiritide (experimental) and Control-Normal saline (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

The primary outcome is days of chest drainage.

The eligible participants will be allocated into intervention and control groups in a 1:1 ratio randomly.

The intervention group will receive study drug.

All the participants will be followed up during hospitalization .

Who Took Part

The registry lists 108 planned participants were the target.

It was open to people of any sex aged up to 14 years.

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

Examples of who could join: Elective general anesthesia down Fontan surgery patients, postoperative retention of patients with thoracic drainage tube. Age ≤ 14 years old between hospitalized patients, men and women are not limited. Postoperative hospital stay\> 7 days. Patients or guardians voluntarily signed informed consent.

The full record lists 4 inclusion and 11 exclusion criteria; among the exclusions: before the group had serious head trauma need hospitalization or brain surgery patients; who received organ transplants; preoperative 48 hours application of recombinant b-type natriuretic peptide drugs.

How the Study Was Run

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

Because people in this BNP (Nesiritide) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

In this single-blind BNP (Nesiritide) study one party knew the assignments and the other did not.

Those kept unaware of assignments: participant.

It started in 2017-07-05 with completion listed for 2020-07-01.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Days of chest drainage (time frame: Up to 18 weeks).

It also tracked 14 secondary outcomes, for example Days of hospitalization after surgery, Postoperative early survival, Measures of heart rate, Measures of heart rhythm, Measures of blood pressure and Measures of central venous pressure.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of BNP (Nesiritide) in 108 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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