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

National Center for Cardiovascular Diseases

Status: Unknown

Conditions: Congenital Heart Disease; Total Cavo-pulmonary Connection

Treatments: Drug: Normal saline; Drug: Nesiritide

Study type: Interventional

Funder types: Other

Identifiers

NCT03207295

2017-898

Details and patient eligibility

About

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.

Full 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.

Enrollment: 108 estimated patients

Sex: All

Ages: Under 14 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. Before the group had serious head trauma need hospitalization or brain surgery patients
2. Who received organ transplants
3. Preoperative 48 hours application of recombinant B-type natriuretic peptide drugs
4. Preoperative cardiogenic shock or hypotension difficult to correct the patient
5. Preoperative patients with active arrhythmia
6. Preoperative serum creatinine> 1.5mg / dl or need dialysis patients
7. Preoperative liver dysfunction (glutamic oxalacetic transaminase /glutamic pyruvate transaminase elevated normal high 3 times or more)
8. Failed Fontan patients requiring secondary surgery
9. Patients with allergic to Nesiritide
10. The researchers believe that should not participate in the entry of patients
11. 3 months before the trial participated in other clinical trials

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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108 participants in 2 patient groups, including a placebo group

Intervention-Nesiritide

Experimental group

Description:

A standard dose of Nesiritide(0.001ug/kg/min) is administered by a continuous infusion for ≥24 hours and ≤7 admission days after cardiac intensive care unit in postoperative children

Treatment:

Drug: Nesiritide

Control-Normal saline

Placebo Comparator group

Description:

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

Treatment:

Drug: Normal saline