Effects of rhBNP in Pediatrics After Corrective Repair of Tetralogy Of Fallot

Study Overview
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Brief Summary
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The purpose of this study is to determine the effects of rhRNP on urine output and hemodynamics following corrective repair of Tetralogy Of Fallot.

Detailed Description
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CVP(central venous pressure) and cardiac output are serious index in children with Tetralogy Of Fallot after the corrective repair.The purpose of this study is to investigate if the therapy of rhRNP can improve the survival and life quality after the corrective repair of Tetralogy Of Fallot.

Official Title
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Effects of rhBNP in Pediatrics After Corrective Repair of Tetralogy Of Fallot

Conditions
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Congenital Heart Defects, Tetralogy Of Fallot

Intervention / Treatment
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* Drug: recombinant human brain natriuretic peptide (rhBNP)
* Drug: Placebo (0.9% sodium chloride)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed informed consent obtained from patient's legally acceptable representative. Pediatric patients after Repair of Tetralogy Of Fallot. Exclusion Criteria: Psychotic, addictive or other disorder limiting the ability to provide informed consent or to comply with study requirements. Treatment or planned treatment with another investigational drug within 3 months of screening. Known hypersensitivity to bosentan or any of the excipients cardiogenic shock and inclination of hypotension（SBP< 60mmHg）.

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: rhBNP Group<br>Patients after corrective repair of Tetralogy Of Fallot will be treat with routinely therapy, including inotropics and diuretics, combined a rhBNP infusion 24 hours after operation. The dose of recombinant human brain natriuretic peptide (rhBNP) will be 1.5 mcg/kg for loading, followed by continuous infusion recombinant human brain natriuretic peptide 0.01-0.01mcg/kg/min for 72 hours. | Drug: recombinant human brain natriuretic peptide (rhBNP)<br>* Patients are first given a loading dose of recombinant human brain natriuretic peptide (rhBNP) 1.5 mcg/kg, followed by continuous infusion recombinant human brain natriuretic peptide 0.01-0.01mcg/kg/min for 72 hours.<br>|
| Placebo Comparator: Placebo Group<br>Patients after corrective repair of Tetralogy Of Fallot will be treat with routinely therapy, including inotropics and diuretics, combined a placebo infusion 24 hours after operation. | Drug: Placebo (0.9% sodium chloride)<br>* Patients after corrective repair of Tetralogy Of Fallot will be treat with routinely therapy, including inotropics and diuretics, combined a placebo infusion 24 hours after operation.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from Baseline in BNP and CVP after the infusion of rhBNP | we will evaluate the cardiac function through the consecutive changed numerical value of brain natriuretic peptide and Central Venous Pressure. | 12 months after operation of Tetralogy Of Fallot | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline on the volume of urine out and numerical value of serum creatinine and blood urea nitrogen | we evaluate the renal function through the volume of urine out and numerical value of serum creatinine and blood urea nitrogen. | 12 months after operation of Tetralogy Of Fallot | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heart defects, Congenital, rhBNP, heart failure