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

NCT01941576 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2020-10-28

No results posted yet for this study

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

Interventions

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.

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.

Sponsors & Collaborators

  • Shanghai Jiao Tong University School of Medicine

    lead OTHER

Principal Investigators

  • Zhuoming Xu, MD,PhD · Shanghai Children's Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Month
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-01
Primary Completion
2017-12-31
Completion
2019-07-20

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01941576 on ClinicalTrials.gov