- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01941576
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
-
-
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.
|
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.
|
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.
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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