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

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: Unknown
• Conditions: Congenital Heart Disease; Total Cavo-pulmonary Connection
• Intervention / Treatment: Drug: Nesiritide; Drug: Normal saline

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: Interventional
• Enrollment (Anticipated): 108
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yan Jun, MD,PhD; Phone Number: 13701025206; Email: yanjun.1112@aliyun.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China
      • Recruiting
      • Fuwai Hospital
      • Contact: Yan Jun, MD,PhD; Email: yanjun.1112@aliyun.com

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Days of chest drainage	Investigators will measure the daily chest drainage flow before discharge	Up to 18 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Days of hospitalization after surgery	Postoperative hospital days	Up to 20 weeks
Postoperative early survival	Number of days alive within 30 days of surgery.	The 30th day after surgery
Measures of heart rate	Investigators will measure the heart rate twice a day(Unit :beats per minute)	Baseline; Up to 20 weeks
Measures of heart rhythm	Investigators will measure the heart rhythm twice a day	Baseline; Up to 20 weeks
Measures of blood pressure	Investigators will measure the blood pressure twice a day(Units :mmHg)	Baseline; Up to 20 weeks
Measures of central venous pressure	Investigators will measure the central venous pressure(Unit :cmH2O)	Up to 20 weeks
Measures of liquid volume	Investigators will measure the liquid volume each day after surgery	Up to 20 weeks
Measures of creatinine	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	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	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	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	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	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	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

• Sponsor: China National Center for Cardiovascular Diseases
• Collaborators: Tibet Kang Zhe Pharmaceutical Technology Co., Ltd
• Investigators: 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

Study Major Dates

• Study Start (Actual): July 5, 2017
• Primary Completion (Anticipated): July 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: June 28, 2017
• First Submitted That Met QC Criteria: June 30, 2017
• First Posted (Actual): July 2, 2017

Study Record Updates

• Last Update Posted (Actual): July 6, 2017
• Last Update Submitted That Met QC Criteria: July 5, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: Congenital Heart Disease; Nesiritide; Total Cavo-Pulmonary Connection
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Heart Diseases; Heart Defects, Congenital; Physiological Effects of Drugs; Natriuretic Agents; Natriuretic Peptide, Brain
• Other Study ID 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