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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rhBNP Group | Experimental | 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. |
|
| Placebo Group | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| recombinant human brain natriuretic peptide (rhBNP) | Drug | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zhuoming Xu, MD,PhD | Shanghai Children's Medical Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiac intensive care unit, Department of cardiothoracic vascular surgery, Shanghai Children's Medical Center, Medical college of Shanghai Jiaotong University | Shanghai | Shanghai Municipality | 200127 | China |
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| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| D013771 | Tetralogy of Fallot |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| Placebo (0.9% sodium chloride) | Drug | 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. |
|
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D017670 |
| Sodium Compounds |