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

NCT03207295 | Unknown DMC

• 1 other identifier: 2017-898
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Nesiritide; Total Cavo-Pulmonary Connection; Congenital Heart Disease

Outcome Measures

Primary Outcomes (1)

• Days of chest drainage

  Investigators will measure the daily chest drainage flow before discharge

  Up to 18 weeks

Secondary Outcomes (14)

• Days of hospitalization after surgery

  Up to 20 weeks

• Postoperative early survival

  The 30th day after surgery

• Measures of heart rate

  Baseline; Up to 20 weeks

• Measures of heart rhythm

  Baseline; Up to 20 weeks

• Measures of blood pressure

  Baseline; Up to 20 weeks

Study Arms (2)

Intervention-Nesiritide

EXPERIMENTAL

A standard dose of Nesiritide(0.001ug/kg/min) is administered by a continuous infusion for ≥24 hours and ≤7 admission days after cardiac intensive care unit in postoperative children

Drug: Nesiritide

Control-Normal saline

PLACEBO COMPARATOR

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

Drug: Normal saline

Interventions

Nesiritide DRUG

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

Intervention-Nesiritide

Normal saline DRUG

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

Control-Normal saline

Eligibility Criteria

• Age: Up to 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Elective general anesthesia down Fontan surgery patients, postoperative retention of patients with thoracic drainage tube
• Age ≤ 14 years old between hospitalized patients, men and women are not limited
• Postoperative hospital stay\> 7 days
• Patients or guardians voluntarily signed informed consent

You may not qualify if:

• Before the group had serious head trauma need hospitalization or brain surgery patients
• Who received organ transplants
• Preoperative 48 hours application of recombinant B-type natriuretic peptide drugs
• Preoperative cardiogenic shock or hypotension difficult to correct the patient
• Preoperative patients with active arrhythmia
• Preoperative serum creatinine\> 1.5mg / dl or need dialysis patients
• Preoperative liver dysfunction (glutamic oxalacetic transaminase /glutamic pyruvate transaminase elevated normal high 3 times or more)
• Failed Fontan patients requiring secondary surgery
• Patients with allergic to Nesiritide
• The researchers believe that should not participate in the entry of patients
• months before the trial participated in other clinical trials

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead
• Tibet Kang Zhe Pharmaceutical Technology Co., Ltd: collaborator

Study Sites (1)

Fuwai hospital

Beijing, Beijing Municipality, China

RECRUITING

MeSH Terms

Conditions

Heart Defects, Congenital

Interventions

Natriuretic Peptide, Brain; Saline Solution

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Natriuretic Peptides; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Zhang Yajuan, MD,PhD

  China National Center for Cardiovascular Disease

  PRINCIPAL INVESTIGATOR

• Duan Yabing, MD

  China National Center for Cardiovascular Disease

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yan Jun, MD,PhD

CONTACT

13701025206; yanjun.1112@aliyun.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2017
• First Posted: July 2, 2017
• Study Start: July 5, 2017
• Primary Completion: July 1, 2020
• Study Completion: December 1, 2020
• Last Updated: July 6, 2017

Record last verified: 2017-06

Locations

CN (1)