Clinical trial NCT03207295: Impact of Nesiritide on Early Postoperative Recovery After Total Cavo-Pulmonary Connection Surgery in Children
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Congenital Heart Disease
Total Cavo-pulmonary Connection
Keywords: Nesiritide
Total Cavo-Pulmonary Connection
Congenital Heart Disease
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
Collaborators: name: Tibet Kang Zhe Pharmaceutical Technology Co., Ltd
First posted: 2017-07-02
Enrollment: 108
Sex: ALL
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Days of chest drainage
timeFrame: Up to 18 weeks
Secondary outcomes:
measure: Days of hospitalization after surgery
timeFrame: Up to 20 weeks
measure: Postoperative early survival
timeFrame: The 30th day after surgery
measure: Measures of heart rate
timeFrame: Baseline; Up to 20 weeks
measure: Measures of heart rhythm
timeFrame: Baseline; Up to 20 weeks
measure: Measures of blood pressure
timeFrame: Baseline; Up to 20 weeks
measure: Measures of central venous pressure
timeFrame: Up to 20 weeks
measure: Measures of liquid volume
timeFrame: Up to 20 weeks
measure: Measures of creatinine
timeFrame: Baseline; 1 day before using nesiritide; day 1 day 3 day 5 day 7 after using nesiritide;
measure: Measures of blood urea nitrogen
timeFrame: Baseline; 1 day before using nesiritide; day 1 day 3 day 5 day 7 after using nesiritide;
measure: Measures of glutamic oxalacetic transaminase
timeFrame: Baseline; 1 day before using nesiritide; day 1 day 3 day 5 day 7 after using nesiritide
measure: Measures of glutamic pyruvate transaminase
timeFrame: Baseline; 1 day before using nesiritide; day 1 day 3 day 5 day 7 after using nesiritide
measure: Measures of total bilirubin
timeFrame: Baseline; 1 day before using nesiritide; day 1 day 3 day 5 day 7 after using nesiritide
measure: Measures of N-terminal pro B-type natriuretic peptide
timeFrame: Baseline; 1 day before using nesiritide; day 1 day 3 day 5 day 7 after using nesiritide
measure: Measures of endothelin
timeFrame: Baseline; 1 day before using nesiritide; day 1 day 3 day 5 day 7 after using nesiritide
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai hospital
state: Beijing
Study officials:
affiliation: China National Center for Cardiovascular Disease
name: Zhang Yajuan, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: China National Center for Cardiovascular Disease
name: Duan Yabing, MD
role: PRINCIPAL_INVESTIGATOR
References: