Ignite Creation Date:
2025-12-24 @ 2:11 PM
Ignite Modification Date:
2025-12-26 @ 6:29 AM
Study NCT ID:
NCT03207295
Status:
UNKNOWN
Last Update Posted:
2017-07-06
First Post:
2017-06-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Nesiritide on Early Postoperative Recovery After Total Cavo-Pulmonary Connection Surgery in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006330', 'term': 'Heart Defects, Congenital'}], 'ancestors': [{'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020097', 'term': 'Natriuretic Peptide, Brain'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D045265', 'term': 'Natriuretic Peptides'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 108}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-07-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2020-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-07-05', 'studyFirstSubmitDate': '2017-06-28', 'studyFirstSubmitQcDate': '2017-06-30', 'lastUpdatePostDateStruct': {'date': '2017-07-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Days of chest drainage', 'timeFrame': 'Up to 18 weeks', 'description': 'Investigators will measure the daily chest drainage flow before discharge'}], 'secondaryOutcomes': [{'measure': 'Days of hospitalization after surgery', 'timeFrame': 'Up to 20 weeks', 'description': 'Postoperative hospital days'}, {'measure': 'Postoperative early survival', 'timeFrame': 'The 30th day after surgery', 'description': 'Number of days alive within 30 days of surgery.'}, {'measure': 'Measures of heart rate', 'timeFrame': 'Baseline; Up to 20 weeks', 'description': 'Investigators will measure the heart rate twice a day(Unit :beats per minute)'}, {'measure': 'Measures of heart rhythm', 'timeFrame': 'Baseline; Up to 20 weeks', 'description': 'Investigators will measure the heart rhythm twice a day'}, {'measure': 'Measures of blood pressure', 'timeFrame': 'Baseline; Up to 20 weeks', 'description': 'Investigators will measure the blood pressure twice a day(Units :mmHg)'}, {'measure': 'Measures of central venous pressure', 'timeFrame': 'Up to 20 weeks', 'description': 'Investigators will measure the central venous pressure(Unit :cmH2O)'}, {'measure': 'Measures of liquid volume', 'timeFrame': 'Up to 20 weeks', 'description': 'Investigators will measure the liquid volume each day after surgery'}, {'measure': 'Measures of creatinine', 'timeFrame': 'Baseline; 1 day before using nesiritide; day 1 day 3 day 5 day 7 after using nesiritide;', 'description': 'Investigators will measure the creatinine(Unit :umol/L)'}, {'measure': 'Measures of blood urea nitrogen', 'timeFrame': 'Baseline; 1 day before using nesiritide; day 1 day 3 day 5 day 7 after using nesiritide;', 'description': 'Investigators will measure the blood urea nitrogen(Unit :mmol/L)'}, {'measure': 'Measures of glutamic oxalacetic transaminase', 'timeFrame': 'Baseline; 1 day before using nesiritide; day 1 day 3 day 5 day 7 after using nesiritide', 'description': 'Investigators will measure the glutamic oxalacetic transaminase(Unit :U/L)'}, {'measure': 'Measures of glutamic pyruvate transaminase', 'timeFrame': 'Baseline; 1 day before using nesiritide; day 1 day 3 day 5 day 7 after using nesiritide', 'description': 'Investigators will measure the glutamic pyruvate transaminase(Unit :U/L)'}, {'measure': 'Measures of total bilirubin', 'timeFrame': 'Baseline; 1 day before using nesiritide; day 1 day 3 day 5 day 7 after using nesiritide', 'description': 'Investigators will measure the total bilirubin(Unit :umol/L)'}, {'measure': 'Measures of N-terminal pro B-type natriuretic peptide', 'timeFrame': 'Baseline; 1 day before using nesiritide; day 1 day 3 day 5 day 7 after using nesiritide', 'description': 'Investigators will measure the N-terminal pro B-type natriuretic peptide(Unit :pg/ml)'}, {'measure': 'Measures of endothelin', 'timeFrame': 'Baseline; 1 day before using nesiritide; day 1 day 3 day 5 day 7 after using nesiritide', 'description': 'Investigators will measure the endothelin(Unit :ng/L)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Nesiritide', 'Total Cavo-Pulmonary Connection', 'Congenital Heart Disease'], 'conditions': ['Congenital Heart Disease', 'Total Cavo-pulmonary Connection']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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 .\n\nStatistical 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Elective general anesthesia down Fontan surgery patients, postoperative retention of patients with thoracic drainage tube\n2. Age ≤ 14 years old between hospitalized patients, men and women are not limited\n3. Postoperative hospital stay\\> 7 days\n4. Patients or guardians voluntarily signed informed consent\n\nExclusion Criteria:\n\n1. Before the group had serious head trauma need hospitalization or brain surgery patients\n2. Who received organ transplants\n3. Preoperative 48 hours application of recombinant B-type natriuretic peptide drugs\n4. Preoperative cardiogenic shock or hypotension difficult to correct the patient\n5. Preoperative patients with active arrhythmia\n6. Preoperative serum creatinine\\> 1.5mg / dl or need dialysis patients\n7. Preoperative liver dysfunction (glutamic oxalacetic transaminase /glutamic pyruvate transaminase elevated normal high 3 times or more)\n8. Failed Fontan patients requiring secondary surgery\n9. Patients with allergic to Nesiritide\n10. The researchers believe that should not participate in the entry of patients\n11. 3 months before the trial participated in other clinical trials'}, 'identificationModule': {'nctId': 'NCT03207295', 'briefTitle': 'Impact of Nesiritide on Early Postoperative Recovery After Total Cavo-Pulmonary Connection Surgery in Children', 'organization': {'class': 'OTHER_GOV', 'fullName': 'China National Center for Cardiovascular Diseases'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '2017-898'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention-Nesiritide', 'description': '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', 'interventionNames': ['Drug: Nesiritide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control-Normal saline', 'description': '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', 'interventionNames': ['Drug: Normal saline']}], 'interventions': [{'name': 'Nesiritide', 'type': 'DRUG', 'description': 'A standard dose of study drug was administered by a continuous infusion for ≥24 hours and ≤7 days after cardiac intensive care unit admission', 'armGroupLabels': ['Intervention-Nesiritide']}, {'name': 'Normal saline', 'type': 'DRUG', 'description': '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', 'armGroupLabels': ['Control-Normal saline']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yan Jun, MD,PhD', 'role': 'CONTACT', 'email': 'yanjun.1112@aliyun.com'}], 'facility': 'Fuwai hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Yan Jun, MD,PhD', 'role': 'CONTACT', 'email': 'yanjun.1112@aliyun.com', 'phone': '13701025206'}], 'overallOfficials': [{'name': 'Zhang Yajuan, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'China National Center for Cardiovascular Disease'}, {'name': 'Duan Yabing, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'China National Center for Cardiovascular Disease'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Consent for sharing of non identifiable study data for regulatory authorities'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'China National Center for Cardiovascular Diseases', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Tibet Kang Zhe Pharmaceutical Technology Co., Ltd', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}