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

Sponsor

Shanghai Jiao Tong University School of Medicine (Other)

Overall Status

Completed

CT.gov ID

NCT01941576

Collaborator

(none)

120

Enrollment

Location

Arms

70.6

Actual Duration (Months)

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Congenital Heart Defects Tetralogy Of Fallot	Drug: recombinant human brain natriuretic peptide (rhBNP) Drug: Placebo (0.9% sodium chloride)	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 1, 2013

Actual Primary Completion Date :

Dec 31, 2017

Actual Study Completion Date :

Jul 20, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: rhBNP Group 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) 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 Comparator: Placebo Group 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) 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.

Arm

Intervention/Treatment

Experimental: rhBNP Group

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)

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 Comparator: Placebo Group

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)

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.

Outcome Measures

Primary Outcome Measures

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

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Month to 18 Years

Sexes Eligible for Study:

All

Accepts 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）.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cardiac intensive care unit, Department of cardiothoracic vascular surgery, Shanghai Children's Medical Center, Medical college of Shanghai Jiaotong University	Shanghai	Shanghai	China	200127