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

Not Applicable

Completed

• Conditions: Congenital Heart Defects; Tetralogy Of Fallot
• Interventions: Drug: recombinant human brain natriuretic peptide (rhBNP); Drug: Placebo (0.9% sodium chloride)

• Registration Number: NCT01941576
• Lead Sponsor: Shanghai Jiao Tong University School of Medicine

Brief Summary

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

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.

Study Timeline

• Study Start: 2013-09-01
• Study First Submitted: 2013-09-03
• Study First Submitted QC: 2013-09-09
• Study First Posted: 2013-09-13
• Primary Completion: 2017-12-31
• Study Completion: 2019-07-20
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-26
• Last Update Posted: 2020-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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）.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
rhBNP Group	recombinant human brain natriuretic peptide (rhBNP)	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 (0.9% sodium chloride)	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Changes from baseline on the volume of urine out and numerical value of serum creatinine and blood urea nitrogen	12 months after operation of Tetralogy Of Fallot	we evaluate the renal function through the volume of urine out and numerical value of serum creatinine and blood urea nitrogen.

Trial Locations

Locations (1)

Cardiac intensive care unit, Department of cardiothoracic vascular surgery, Shanghai Children's Medical Center, Medical college of Shanghai Jiaotong University; 🇨🇳 Shanghai, Shanghai, China