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

NCT ID: NCT01941576

Last Updated: 2020-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-01

Study Completion Date

2019-07-20

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Congenital Heart Defects Tetralogy Of Fallot

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

recombinant human brain natriuretic peptide (rhBNP)

Intervention Type 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.

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.

Group Type PLACEBO_COMPARATOR

Placebo (0.9% sodium chloride)

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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）.
Minimum Eligible Age

1 Month

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Xu Zhuoming

Vice Chief, Department of thoracic and cardiovascular surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zhuoming Xu, MD,PhD

Role: STUDY_DIRECTOR

Shanghai Children's Medical Center

Locations

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

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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SJTUMS-20130903

Identifier Type: -

Identifier Source: org_study_id