NCT03207295

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

A Randomized, Single-Blind, Placebo-Controlled, Single-Center Clinical Study of the Efficacy and Safety of Nesiritide on Early Postoperative Recovery After Total Cavo-Pulmonary Connection Surgery in Children

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 108 (estimated)
• Sponsor: China National Center for Cardiovascular Diseases · Other Government
• Sex: All
• Age: 14 Years
• Healthy volunteers: Not accepted

Summary

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. Investigators seek to determine whether nesiritide would improve the early postoperative course after total cavo-pulmonary connection surgery in children.

Detailed description

Objective: This study aims to evaluate the efficacy and safety of nesiritide after total cavo-pulmonary connection surgery in children. Investigators hypothesized that compared with placebo, patients assigned to receive nesiritide will improve early postoperative outcomes. Study design: The study is a a single-center, randomized, single-blinded, placebo-controlled, two-arm parallel-group clinical trial, patients undergoing total cavo-pulmonary connection surgery are assigned to receive nesiritide or placebo. A standard dose of study drug was administered by a continuous infusion for ≥24 hours and ≤7 days after cardiac intensive care unit admission. The primary outcome is days of chest drainage. Secondary outcomes included days of hospitalization measures of cardiovascular function, renal function, and adverse events and neurohumoral. 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 . Statistical analysis: Evaluation will be carried out on an intention-to-treat basis. Values of analyzed endpoints between intervention group and control group will be compared according to the analysis plan.

Conditions

• Congenital Heart Disease
• Total Cavo-pulmonary Connection

Interventions

Type	Name	Description
DRUG	Nesiritide	A standard dose of study drug was administered by a continuous infusion for ≥24 hours and ≤7 days after cardiac intensive care unit admission
DRUG	Normal saline	Normal saline(2ml/h) is administered by a continuous infusion for ≥24 hours and ≤7 admission days after cardiac intensive care unit in postoperative children

Timeline

• Start date: 2017-07-05
• Primary completion: 2020-07-01
• Completion: 2020-12-01
• First posted: 2017-07-02
• Last updated: 2017-07-06

Locations

1 site across 1 country: China