Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 10:48 PM
Study NCT ID:
NCT06195267
Status:
RECRUITING
Last Update Posted:
2024-11-22
First Post:
2023-12-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Protective Effect of Sivelestat Against Negative Pulmonary Function and Organ Dysfunction After Cardiovascular Surgery (PANDA VI)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000784', 'term': 'Aortic Dissection'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}], 'ancestors': [{'id': 'D000094665', 'term': 'Dissection, Blood Vessel'}, {'id': 'D000783', 'term': 'Aneurysm'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D000094683', 'term': 'Acute Aortic Syndrome'}, {'id': 'D001018', 'term': 'Aortic Diseases'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012769', 'term': 'Shock'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C069195', 'term': 'sivelestat'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-20', 'studyFirstSubmitDate': '2023-12-23', 'studyFirstSubmitQcDate': '2023-12-23', 'lastUpdatePostDateStruct': {'date': '2024-11-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The highest SOFA score of 7 days after surgery', 'timeFrame': '7 days after surgery', 'description': 'The daily SOFA score after baseline was calculated for each patient on the basis of five organ systems: cardiovascular, respiratory, renal, hepatic, and coagulation systems. (Scores for each system range from 0 to 4, with higher scores indicating more severe organ-system dysfunction).'}], 'secondaryOutcomes': [{'measure': 'all-cause mortality', 'timeFrame': '30 days after surgery'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Systemic Inflammatory Response Syndrome'], 'conditions': ['Aortic Dissection', 'Systemic Inflammatory Response Syndrome', 'Cardiovascular Diseases (CVD)']}, 'descriptionModule': {'briefSummary': 'Systemic inflammatory response syndrome (SIRS) and multiple organ dysfunction syndrome (MODS) are the major causes of death in patients with cardiovascular diseases. Therefore, the prevention of SIRS and MODS is of great clinical value, and immunomodulatory therapy with sivelestat may be beneficial. This study was designed to test the hypothesis that the administration of sivelestat during the acute phase of cardiovascular diseases will result in a reduced incidence of SIRS and MODS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* The patients are conformed to 2010 ACC/AHA guidelines for the diagnosis and treatment of thoracic aortic disease (TAD) within two weeks of onset;\n* Patients with type A acute aortic syndrome confirmed clinically and radiologically and planning to undergo emergency surgery were enrolled.\n* The patients' age between 18 \\~90 years old.\n* Agree to participate in the study and sign the informed consent.\n\nExclusion Criteria:\n\n* Patients allergic to sivelestat sodium;\n* Lactating women and pregnant women;\n* Patients with mental diseases, drug and alcohol dependence;\n* Refuse to participate in this study and refuse to sign the informed consent."}, 'identificationModule': {'nctId': 'NCT06195267', 'acronym': 'PANDA', 'briefTitle': 'Protective Effect of Sivelestat Against Negative Pulmonary Function and Organ Dysfunction After Cardiovascular Surgery (PANDA VI)', 'organization': {'class': 'OTHER', 'fullName': 'Nanjing Medical University'}, 'officialTitle': 'Protective Effect of Sivelestat Against Negative Pulmonary Function and Organ Dysfunction After Cardiovascular Surgery (PANDA VI)', 'orgStudyIdInfo': {'id': 'PANDA VI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sivelestat', 'interventionNames': ['Drug: Sivelestat']}, {'type': 'SHAM_COMPARATOR', 'label': 'Blank control', 'description': 'The control group did not receive any intervention.', 'interventionNames': ['Drug: Blank control']}], 'interventions': [{'name': 'Sivelestat', 'type': 'DRUG', 'description': 'The total 24-hour dose of Sivelestat sodium (4.8mg/kg) was dissolved with 50 ml normal saline. The drug flow rate was set at 2ml/h with an intravenous microinfusion pump, and the constant speed infusion was completed in 24h.', 'armGroupLabels': ['Sivelestat']}, {'name': 'Blank control', 'type': 'DRUG', 'description': 'Patients only received standard treatment and care.', 'armGroupLabels': ['Blank control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Si-chong Qian, MD', 'role': 'CONTACT', 'email': 'drqsc1990a@163.com', 'phone': '+8613120130755'}, {'name': 'Si-chong Qian, MD', 'role': 'CONTACT'}], 'facility': 'Beijing Anzhen Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Nanjing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hong Liu, MD', 'role': 'CONTACT', 'email': 'dr.hongliu@foxmail.com', 'phone': '+8618801281613'}, {'name': 'Sheng Zhao, MD', 'role': 'CONTACT', 'email': 'zhaosheng0824@163.com', 'phone': '02568303105'}, {'name': 'Hong Liu, MD', 'role': 'CONTACT'}], 'facility': 'The First Affiliated Hospital of Nanjing Medical University and Jiang ye-fan', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'centralContacts': [{'name': 'Hong Liu, MD', 'role': 'CONTACT', 'email': 'dr.hongliu@foxmail.com', 'phone': '+8618801281613'}, {'name': 'Sheng Zhao, MD', 'role': 'CONTACT', 'email': 'zhaosheng0824@163.com', 'phone': '02568303105'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanjing Medical University', 'class': 'OTHER'}, 'collaborators': [{'name': 'The First Affiliated Hospital with Nanjing Medical University', 'class': 'OTHER'}, {'name': 'Beijing Anzhen Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator of Cardiovascular Surgery', 'investigatorFullName': 'Hong Liu', 'investigatorAffiliation': 'Nanjing Medical University'}}}}