Impact of Nesiritide on Early Postoperative Recovery After Total Cavo-Pulmonary Connection Surgery in Children
- Conditions
- Congenital Heart DiseaseTotal Cavo-pulmonary Connection
- Interventions
- Drug: Normal saline
- Registration Number
- NCT03207295
- Lead Sponsor
- China National Center for Cardiovascular Diseases
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 108
- 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
- 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
- Preoperative cardiogenic shock or hypotension difficult to correct the patient
- Preoperative patients with active arrhythmia
- Preoperative serum creatinine> 1.5mg / dl or need dialysis patients
- Preoperative liver dysfunction (glutamic oxalacetic transaminase /glutamic pyruvate transaminase elevated normal high 3 times or more)
- Failed Fontan patients requiring secondary surgery
- Patients with allergic to Nesiritide
- The researchers believe that should not participate in the entry of patients
- 3 months before the trial participated in other clinical trials
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control-Normal saline 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 Intervention-Nesiritide Nesiritide 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
- Primary Outcome Measures
Name Time Method Days of chest drainage Up to 18 weeks Investigators will measure the daily chest drainage flow before discharge
- Secondary Outcome Measures
Name Time Method Postoperative early survival The 30th day after surgery Number of days alive within 30 days of surgery.
Measures of blood pressure Baseline; Up to 20 weeks Investigators will measure the blood pressure twice a day(Units :mmHg)
Measures of creatinine Baseline; 1 day before using nesiritide; day 1 day 3 day 5 day 7 after using nesiritide; Investigators will measure the creatinine(Unit :umol/L)
Measures of endothelin Baseline; 1 day before using nesiritide; day 1 day 3 day 5 day 7 after using nesiritide Investigators will measure the endothelin(Unit :ng/L)
Measures of central venous pressure Up to 20 weeks Investigators will measure the central venous pressure(Unit :cmH2O)
Measures of liquid volume Up to 20 weeks Investigators will measure the liquid volume each day after surgery
Measures of blood urea nitrogen Baseline; 1 day before using nesiritide; day 1 day 3 day 5 day 7 after using nesiritide; Investigators will measure the blood urea nitrogen(Unit :mmol/L)
Measures of glutamic oxalacetic transaminase Baseline; 1 day before using nesiritide; day 1 day 3 day 5 day 7 after using nesiritide Investigators will measure the glutamic oxalacetic transaminase(Unit :U/L)
Measures of glutamic pyruvate transaminase Baseline; 1 day before using nesiritide; day 1 day 3 day 5 day 7 after using nesiritide Investigators will measure the glutamic pyruvate transaminase(Unit :U/L)
Days of hospitalization after surgery Up to 20 weeks Postoperative hospital days
Measures of heart rate Baseline; Up to 20 weeks Investigators will measure the heart rate twice a day(Unit :beats per minute)
Measures of heart rhythm Baseline; Up to 20 weeks Investigators will measure the heart rhythm twice a day
Measures of total bilirubin Baseline; 1 day before using nesiritide; day 1 day 3 day 5 day 7 after using nesiritide Investigators will measure the total bilirubin(Unit :umol/L)
Measures of N-terminal pro B-type natriuretic peptide Baseline; 1 day before using nesiritide; day 1 day 3 day 5 day 7 after using nesiritide Investigators will measure the N-terminal pro B-type natriuretic peptide(Unit :pg/ml)
Trial Locations
- Locations (1)
Fuwai hospital
🇨🇳Beijing, Beijing, China