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
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Days of chest drainage
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- — 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Intervention-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
干预措施: Nesiritide (Drug)
Control-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
干预措施: Normal saline (Drug)
结局指标
主要结局
Days of chest drainage
时间窗: Up to 18 weeks
Investigators will measure the daily chest drainage flow before discharge
次要结局
- Postoperative early survival(The 30th day after surgery)
- Measures of blood pressure(Baseline; Up to 20 weeks)
- Measures of creatinine(Baseline; 1 day before using nesiritide; day 1 day 3 day 5 day 7 after using nesiritide;)
- Measures of endothelin(Baseline; 1 day before using nesiritide; day 1 day 3 day 5 day 7 after using nesiritide)
- Measures of central venous pressure(Up to 20 weeks)
- Measures of liquid volume(Up to 20 weeks)
- Measures of blood urea nitrogen(Baseline; 1 day before using nesiritide; day 1 day 3 day 5 day 7 after using nesiritide;)
- Measures of glutamic oxalacetic transaminase(Baseline; 1 day before using nesiritide; day 1 day 3 day 5 day 7 after using nesiritide)
- Measures of glutamic pyruvate transaminase(Baseline; 1 day before using nesiritide; day 1 day 3 day 5 day 7 after using nesiritide)
- Days of hospitalization after surgery(Up to 20 weeks)
- Measures of heart rate(Baseline; Up to 20 weeks)
- Measures of heart rhythm(Baseline; Up to 20 weeks)
- Measures of total bilirubin(Baseline; 1 day before using nesiritide; day 1 day 3 day 5 day 7 after using nesiritide)
- 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)