Impact of Nesiritide on Early Postoperative Recovery After Total Cavo-Pulmonary Connection Surgery in Children

NCT03207295 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2017-07-06

No results posted yet for this study

Summary

Nesiritide, a recombinant human B-type natriuretic peptide, has favorable effects on patient symptoms, hemodynamics, and the neurohumoral profile in adults with decompensated congestive heart failure and in those recovering from cardiac surgery involving cardiopulmonary bypass. Investigators seek to determine whether nesiritide would improve the early postoperative course after total cavo-pulmonary connection surgery in children.

Conditions

  • Congenital Heart Disease
  • Total Cavo-pulmonary Connection

Interventions

DRUG

Nesiritide

A standard dose of study drug was administered by a continuous infusion for ≥24 hours and ≤7 days after cardiac intensive care unit admission

DRUG

Normal saline

Normal saline(2ml/h) is administered by a continuous infusion for ≥24 hours and ≤7 admission days after cardiac intensive care unit in postoperative children

Sponsors & Collaborators

  • Tibet Kang Zhe Pharmaceutical Technology Co., Ltd

    collaborator UNKNOWN
  • China National Center for Cardiovascular Diseases

    lead OTHER_GOV

Principal Investigators

  • Zhang Yajuan, MD,PhD · China National Center for Cardiovascular Disease

  • Duan Yabing, MD · China National Center for Cardiovascular Disease

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Max Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-07-05
Primary Completion
2020-07-01
Completion
2020-12-01

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 NCT03207295 on ClinicalTrials.gov