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

NCT01941576 | Completed DMC

• 1 other identifier: SJTUMS-20130903
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Congenital Heart Defects; Tetralogy Of Fallot

Keywords

Heart defects, Congenital; rhBNP; heart failure

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months after operation of Tetralogy Of Fallot

Secondary Outcomes (1)

• Changes from baseline on the volume of urine out and numerical value of serum creatinine and blood urea nitrogen

  12 months after operation of Tetralogy Of Fallot

Study Arms (2)

rhBNP Group

EXPERIMENTAL

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)

Placebo Group

PLACEBO COMPARATOR

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)

Interventions

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.

rhBNP Group

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.

Placebo Group

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Signed informed consent obtained from patient's legally acceptable representative.
• Pediatric patients after Repair of Tetralogy Of Fallot.

You may not qualify if:

• 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）.

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

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

Location

MeSH Terms

Conditions

Heart Defects, Congenital; Tetralogy of Fallot; Heart Failure

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Zhuoming Xu, MD,PhD

  Shanghai Children's Medical Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Chief, Department of thoracic and cardiovascular surgery

Study Record Dates

• First Submitted: September 3, 2013
• First Posted: September 13, 2013
• Study Start: September 1, 2013
• Primary Completion: December 31, 2017
• Study Completion: July 20, 2019
• Last Updated: October 28, 2020

Record last verified: 2020-10

Locations

CN (1)