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

July 5, 2017 updated by: China National Center for Cardiovascular Diseases

A Randomized, Single-Blind, Placebo-Controlled, Single-Center Clinical Study of the Efficacy and Safety of Nesiritide on Early Postoperative Recovery After Total Cavo-Pulmonary Connection Surgery in Children

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Objective: This study aims to evaluate the efficacy and safety of nesiritide after total cavo-pulmonary connection surgery in children. Investigators hypothesized that compared with placebo, patients assigned to receive nesiritide will improve early postoperative outcomes. Study design: The study is a a single-center, randomized, single-blinded, placebo-controlled, two-arm parallel-group clinical trial, patients undergoing total cavo-pulmonary connection surgery are assigned to receive nesiritide or placebo. A standard dose of study drug was administered by a continuous infusion for ≥24 hours and ≤7 days after cardiac intensive care unit admission. The primary outcome is days of chest drainage. Secondary outcomes included days of hospitalization measures of cardiovascular function, renal function, and adverse events and neurohumoral. The eligible participants will be allocated into intervention and control groups in a 1:1 ratio randomly. The intervention group will receive study drug. All the participants will be followed up during hospitalization .

Statistical analysis: Evaluation will be carried out on an intention-to-treat basis. Values of analyzed endpoints between intervention group and control group will be compared according to the analysis plan.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
108

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

No older than 14 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Before the group had serious head trauma need hospitalization or brain surgery patients
  2. Who received organ transplants
  3. Preoperative 48 hours application of recombinant B-type natriuretic peptide drugs
  4. Preoperative cardiogenic shock or hypotension difficult to correct the patient
  5. Preoperative patients with active arrhythmia
  6. Preoperative serum creatinine> 1.5mg / dl or need dialysis patients
  7. Preoperative liver dysfunction (glutamic oxalacetic transaminase /glutamic pyruvate transaminase elevated normal high 3 times or more)
  8. Failed Fontan patients requiring secondary surgery
  9. Patients with allergic to Nesiritide
  10. The researchers believe that should not participate in the entry of patients
  11. 3 months before the trial participated in other clinical trials

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention-Nesiritide
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
A standard dose of study drug was administered by a continuous infusion for ≥24 hours and ≤7 days after cardiac intensive care unit admission
Placebo Comparator: Control-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
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Days of chest drainage
Time Frame: Up to 18 weeks
Investigators will measure the daily chest drainage flow before discharge
Up to 18 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Days of hospitalization after surgery
Time Frame: Up to 20 weeks
Postoperative hospital days
Up to 20 weeks
Postoperative early survival
Time Frame: The 30th day after surgery
Number of days alive within 30 days of surgery.
The 30th day after surgery
Measures of heart rate
Time Frame: Baseline; Up to 20 weeks
Investigators will measure the heart rate twice a day(Unit :beats per minute)
Baseline; Up to 20 weeks
Measures of heart rhythm
Time Frame: Baseline; Up to 20 weeks
Investigators will measure the heart rhythm twice a day
Baseline; Up to 20 weeks
Measures of blood pressure
Time Frame: Baseline; Up to 20 weeks
Investigators will measure the blood pressure twice a day(Units :mmHg)
Baseline; Up to 20 weeks
Measures of central venous pressure
Time Frame: Up to 20 weeks
Investigators will measure the central venous pressure(Unit :cmH2O)
Up to 20 weeks
Measures of liquid volume
Time Frame: Up to 20 weeks
Investigators will measure the liquid volume each day after surgery
Up to 20 weeks
Measures of creatinine
Time Frame: Baseline; 1 day before using nesiritide; day 1 day 3 day 5 day 7 after using nesiritide;
Investigators will measure the creatinine(Unit :umol/L)
Baseline; 1 day before using nesiritide; day 1 day 3 day 5 day 7 after using nesiritide;
Measures of blood urea nitrogen
Time Frame: Baseline; 1 day before using nesiritide; day 1 day 3 day 5 day 7 after using nesiritide;
Investigators will measure the blood urea nitrogen(Unit :mmol/L)
Baseline; 1 day before using nesiritide; day 1 day 3 day 5 day 7 after using nesiritide;
Measures of glutamic oxalacetic transaminase
Time Frame: Baseline; 1 day before using nesiritide; day 1 day 3 day 5 day 7 after using nesiritide
Investigators will measure the glutamic oxalacetic transaminase(Unit :U/L)
Baseline; 1 day before using nesiritide; day 1 day 3 day 5 day 7 after using nesiritide
Measures of glutamic pyruvate transaminase
Time Frame: Baseline; 1 day before using nesiritide; day 1 day 3 day 5 day 7 after using nesiritide
Investigators will measure the glutamic pyruvate transaminase(Unit :U/L)
Baseline; 1 day before using nesiritide; day 1 day 3 day 5 day 7 after using nesiritide
Measures of total bilirubin
Time Frame: Baseline; 1 day before using nesiritide; day 1 day 3 day 5 day 7 after using nesiritide
Investigators will measure the total bilirubin(Unit :umol/L)
Baseline; 1 day before using nesiritide; day 1 day 3 day 5 day 7 after using nesiritide
Measures of N-terminal pro B-type natriuretic peptide
Time Frame: Baseline; 1 day before using nesiritide; day 1 day 3 day 5 day 7 after using nesiritide
Investigators will measure the N-terminal pro B-type natriuretic peptide(Unit :pg/ml)
Baseline; 1 day before using nesiritide; day 1 day 3 day 5 day 7 after using nesiritide
Measures of endothelin
Time Frame: Baseline; 1 day before using nesiritide; day 1 day 3 day 5 day 7 after using nesiritide
Investigators will measure the endothelin(Unit :ng/L)
Baseline; 1 day before using nesiritide; day 1 day 3 day 5 day 7 after using nesiritide

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
China National Center for Cardiovascular Diseases

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Tibet Kang Zhe Pharmaceutical Technology Co., Ltd

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Zhang Yajuan, MD,PhD, China National Center for Cardiovascular Disease
  • Principal Investigator: Duan Yabing, MD, China National Center for Cardiovascular Disease

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 5, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 28, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 30, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 2, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 6, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 5, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2017-898

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Consent for sharing of non identifiable study data for regulatory authorities

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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