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

Primary Purpose

Congenital Heart Defects, Tetralogy Of Fallot

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
recombinant human brain natriuretic peptide (rhBNP)
Placebo (0.9% sodium chloride)
Sponsored by
Shanghai Jiao Tong University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Congenital Heart Defects focused on measuring Heart defects, Congenital, rhBNP, heart failure

Eligibility Criteria

1 Month - 18 Years (Child, Adult)All SexesDoes not accept 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）.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

rhBNP Group

Placebo Group

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
September 3, 2013
Last Updated
October 26, 2020
Sponsor
Shanghai Jiao Tong University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT01941576
Brief Title
Effects of rhBNP in Pediatrics After Corrective Repair of Tetralogy Of Fallot
Official Title
Effects of rhBNP in Pediatrics After Corrective Repair of Tetralogy Of Fallot
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
September 1, 2013 (Actual)
Primary Completion Date
December 31, 2017 (Actual)
Study Completion Date
July 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Jiao Tong University School of Medicine

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Heart Defects, Tetralogy Of Fallot
Keywords
Heart defects, Congenital, rhBNP, heart failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
rhBNP Group
Arm Type
Experimental
Arm 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.
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Drug
Intervention Name(s)
recombinant human brain natriuretic peptide (rhBNP)
Intervention Description
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
Intervention Name(s)
Placebo (0.9% sodium chloride)
Intervention 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.
Primary Outcome Measure Information:
Title
Changes from Baseline in BNP and CVP after the infusion of rhBNP
Description
we will evaluate the cardiac function through the consecutive changed numerical value of brain natriuretic peptide and Central Venous Pressure.
Time Frame
12 months after operation of Tetralogy Of Fallot
Secondary Outcome Measure Information:
Title
Changes from baseline on the volume of urine out and numerical value of serum creatinine and blood urea nitrogen
Description
we evaluate the renal function through 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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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）.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhuoming Xu, MD,PhD
Organizational Affiliation
Shanghai Children's Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Cardiac intensive care unit, Department of cardiothoracic vascular surgery, Shanghai Children's Medical Center, Medical college of Shanghai Jiaotong University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200127
Country
China

12. IPD Sharing Statement

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

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