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

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ClinicalTrials.gov Identifier: NCT01941576
Recruitment Status : Unknown
Verified January 2016 by Xu Zhuoming, Shanghai Jiao Tong University School of Medicine.
Recruitment status was:  Recruiting
First Posted : September 13, 2013
Last Update Posted : April 21, 2016
Sponsor:
Information provided by (Responsible Party):
Xu Zhuoming, Shanghai Jiao Tong University School of Medicine

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.

Condition or disease Intervention/treatment Phase
Congenital Heart Defects Tetralogy Of Fallot Drug: recombinant human brain natriuretic peptide (rhBNP) Drug: Placebo (0.9% sodium chloride) Phase 2 Phase 3

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  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of rhBNP in Pediatrics After Corrective Repair of Tetralogy Of Fallot
Study Start Date : September 2013
Estimated Primary Completion Date : September 2016

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   1 Month to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01941576


Locations
China, Shanghai
Cardiac intensive care unit, Department of cardiothoracic vascular surgery, Shanghai Children's Medical Center, Medical college of Shanghai Jiaotong University Recruiting
Shanghai, Shanghai, China, 200127
Contact: Zhuoming Xu, MD PhD    86213501699158    zmxyfb@aliyun.com   
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
Investigators
Study Director: Zhuoming Xu, MD,PhD Cardiac intensive care unit, Department of cardiothoracic vascular surgery, Shanghai Children's Medical Center

Responsible Party: Xu Zhuoming, Vice Chief, Department of thoracic and cardiovascular surgery, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT01941576     History of Changes
Other Study ID Numbers: SJTUMS-20130903
First Posted: September 13, 2013    Key Record Dates
Last Update Posted: April 21, 2016
Last Verified: January 2016

Keywords provided by Xu Zhuoming, Shanghai Jiao Tong University School of Medicine:
Heart defects, Congenital
rhBNP
heart failure

Additional relevant MeSH terms:
Heart Defects, Congenital
Tetralogy of Fallot
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Congenital Abnormalities
Diuretics
Natriuretic Peptide, Brain
Natriuretic Agents
Physiological Effects of Drugs