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

Tetralogy Of Fallot Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01941576
• Other study ID #: SJTUMS-20130903
• Status: Completed
• Phase: N/A
• Start date: September 1, 2013
• Est. completion date: July 20, 2019

Study information

• Verified date: October 2020
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: July 20, 2019
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 18 Years

Eligibility

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).

Related Conditions & MeSH terms

• Congenital Heart Defects
• Heart Defects, Congenital
• Tetralogy of Fallot

Intervention

Drug:
• recombinant human brain natriuretic peptide (rhBNP)
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.
• 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.

Locations

Country	Name	City	State
China	Cardiac intensive care unit, Department of cardiothoracic vascular surgery, Shanghai Children's Medical Center, Medical college of Shanghai Jiaotong University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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