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

October 26, 2020 updated by: Xu Zhuoming, Shanghai Jiao Tong University School of Medicine
The purpose of this study is to determine the effects of rhRNP on urine output and hemodynamics following corrective repair of Tetralogy Of Fallot.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200127
        • Cardiac intensive care unit, Department of cardiothoracic vascular surgery, Shanghai Children's Medical Center, Medical college of Shanghai Jiaotong University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes from Baseline in BNP and CVP after the infusion of rhBNP
Time Frame: 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.
12 months after operation of Tetralogy Of Fallot

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes from baseline on the volume of urine out and numerical value of serum creatinine and blood urea nitrogen
Time Frame: 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.
12 months after operation of Tetralogy Of Fallot

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Jiao Tong University School of Medicine

Investigators

  • Study Director: Zhuoming Xu, MD,PhD, Shanghai Children's Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2013

Primary Completion (ACTUAL)

December 31, 2017

Study Completion (ACTUAL)

July 20, 2019

Study Registration Dates

First Submitted

September 3, 2013

First Submitted That Met QC Criteria

September 9, 2013

First Posted (ESTIMATE)

September 13, 2013

Study Record Updates

Last Update Posted (ACTUAL)

October 28, 2020

Last Update Submitted That Met QC Criteria

October 26, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SJTUMS-20130903

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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