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

Congenital Heart Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03207295
• Other study ID #: 2017-898
• Status: Recruiting
• Phase: N/A
• First received: June 28, 2017
• Last updated: July 5, 2017
• Start date: July 5, 2017
• Est. completion date: December 1, 2020

Study information

• Verified date: June 2017
• Source: China National Center for Cardiovascular Diseases
• Contact: Yan Jun, MD,PhD
• Phone: 13701025206
• Email: yanjun.1112[@]aliyun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 108
• Est. completion date: December 1, 2020
• Est. primary completion date: July 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases
• Total Cavo-pulmonary Connection

Intervention

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
• 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

Locations

Country	Name	City	State
China	Fuwai hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
China National Center for Cardiovascular Diseases	Tibet Kang Zhe Pharmaceutical Technology Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Days of chest drainage	Investigators will measure the daily chest drainage flow before discharge	Up to 18 weeks
Secondary	Days of hospitalization after surgery	Postoperative hospital days	Up to 20 weeks
Secondary	Postoperative early survival	Number of days alive within 30 days of surgery.	The 30th day after surgery
Secondary	Measures of heart rate	Investigators will measure the heart rate twice a day(Unit :beats per minute)	Baseline; Up to 20 weeks
Secondary	Measures of heart rhythm	Investigators will measure the heart rhythm twice a day	Baseline; Up to 20 weeks
Secondary	Measures of blood pressure	Investigators will measure the blood pressure twice a day(Units :mmHg)	Baseline; Up to 20 weeks
Secondary	Measures of central venous pressure	Investigators will measure the central venous pressure(Unit :cmH2O)	Up to 20 weeks
Secondary	Measures of liquid volume	Investigators will measure the liquid volume each day after surgery	Up to 20 weeks
Secondary	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;
Secondary	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;
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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