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

Shanghai Jiao Tong University School of Medicine

Status: Completed

Conditions: Congenital Heart Defects; Tetralogy Of Fallot

Treatments: Drug: recombinant human brain natriuretic peptide (rhBNP); Drug: Placebo (0.9% sodium chloride)

Study type: Interventional

Funder types: Other

Identifiers

NCT01941576

SJTUMS-20130903

Details and patient eligibility

About

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

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 1 month to 18 years old

Volunteers: No Healthy Volunteers

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）.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 2 patient groups, including a placebo group

rhBNP Group

Experimental group

Description:

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.

Treatment:

Drug: recombinant human brain natriuretic peptide (rhBNP)

Placebo Group

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo (0.9% sodium chloride)