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| Name | Class |
|---|---|
| Tibet Kang Zhe Pharmaceutical Technology Co., Ltd | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Days of chest drainage | Investigators will measure the daily chest drainage flow before discharge | Up to 18 weeks |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yan Jun, MD,PhD | Contact | 13701025206 | yanjun.1112@aliyun.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhang Yajuan, MD,PhD | China National Center for Cardiovascular Disease | Principal Investigator |
| Duan Yabing, MD | China National Center for Cardiovascular Disease | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuwai hospital | Recruiting | Beijing | Beijing Municipality | China |
Consent for sharing of non identifiable study data for regulatory authorities
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| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
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| ID | Term |
|---|---|
| D020097 | Natriuretic Peptide, Brain |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D045265 | Natriuretic Peptides |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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| 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 |
|
| 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 |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |