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

N/AUnknownNCT03207295

China National Center for Cardiovascular Diseases108 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

108

Eligibility

Sex: ALLMax age: 14 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Days of chest drainage

Investigators will measure the daily chest drainage flow before discharge

Time frame: Up to 18 weeks

Secondary Outcomes

Days of hospitalization after surgery

Postoperative hospital days

Time frame: Up to 20 weeks

Postoperative early survival

Number of days alive within 30 days of surgery.

Time frame: The 30th day after surgery

Measures of heart rate

Investigators will measure the heart rate twice a day(Unit :beats per minute)

Time frame: Baseline; Up to 20 weeks

Measures of heart rhythm

Investigators will measure the heart rhythm twice a day

Time frame: Baseline; Up to 20 weeks

Measures of blood pressure

Investigators will measure the blood pressure twice a day(Units :mmHg)

Time frame: Baseline; Up to 20 weeks

Measures of central venous pressure

Investigators will measure the central venous pressure(Unit :cmH2O)

Time frame: Up to 20 weeks

Measures of liquid volume

Investigators will measure the liquid volume each day after surgery

Time frame: Up to 20 weeks

Measures of creatinine

Investigators will measure the creatinine(Unit :umol/L)

Time frame: Baseline; 1 day before using nesiritide; day 1 day 3 day 5 day 7 after using nesiritide;

Measures of blood urea nitrogen

Investigators will measure the blood urea nitrogen(Unit :mmol/L)

Time frame: Baseline; 1 day before using nesiritide; day 1 day 3 day 5 day 7 after using nesiritide;

Measures of glutamic oxalacetic transaminase

Investigators will measure the glutamic oxalacetic transaminase(Unit :U/L)