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Completed

NCT Number: NCT01941576

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

The purpose of this study is to determine the effects of rhRNP on urine output and hemodynamics following corrective repair of Tetralogy Of Fallot.

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Key information

Conditions

Congenital Heart Defects Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Heart Failure Tetralogy of Fallot

Age range

1 month–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Shanghai, Shanghai Municipality, 200127, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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）.

Treatment and study plan

Recombinant Human Brain Natriuretic Peptide (rhBNP)

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 (0.9% Sodium Chloride)

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Shanghai Jiao Tong University School of Medicine

Other

Registry information

Important dates

Study start
2013
Primary completion
2017
Study completion
2019
First posted
Sep 13, 2013
Registry last updated
Oct 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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