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

NCT ID: NCT03207295

Last Updated: 2017-07-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-05
• Study Completion Date: 2020-12-01

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.

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.

Conditions

Congenital Heart Disease; Total Cavo-pulmonary Connection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: EXPERIMENTAL

Nesiritide

Intervention Type: 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

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

Group Type: PLACEBO_COMPARATOR

Normal saline

Intervention Type: 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

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

Eligibility Criteria

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

• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tibet Kang Zhe Pharmaceutical Technology Co., Ltd

UNKNOWN

Sponsor Role: collaborator

China National Center for Cardiovascular Diseases

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zhang Yajuan, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

China National Center for Cardiovascular Disease

Duan Yabing, MD

Role: PRINCIPAL_INVESTIGATOR

China National Center for Cardiovascular Disease

Locations

Fuwai hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yan Jun, MD,PhD

Role: CONTACT

yanjun.1112@aliyun.com

13701025206

Facility Contacts

Yan Jun, MD,PhD

Role: primary

yanjun.1112@aliyun.com

Other Identifiers

2017-898

Identifier Type: -

Identifier Source: org_study_id