Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-25 @ 8:54 PM
Study NCT ID:
NCT07156656
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-05
First Post:
2025-08-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Sivelestat Treatment for Postoperative Organ Protection in Type A Aortic Dissection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009102', 'term': 'Multiple Organ Failure'}], 'ancestors': [{'id': 'D012769', 'term': 'Shock'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'a Multicenter, Double-blind RCT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 236}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2028-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-27', 'studyFirstSubmitDate': '2025-08-20', 'studyFirstSubmitQcDate': '2025-08-27', 'lastUpdatePostDateStruct': {'date': '2025-09-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2028-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Plasma neutrophil elastase levels (exploratory outcome)', 'timeFrame': 'from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the first dose)', 'description': 'Plasma concentration of neutrophil elastase at 1day, 3day and 5day after the first dose in 40 participants enrolled at the main center (20 per arm).'}], 'primaryOutcomes': [{'measure': 'ΔSOFA5', 'timeFrame': 'from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the first dose)', 'description': 'ΔSOFA5 is defined as the decrease level of SOFA(Sequential Organ Failure Assessment) score from baseline to the fifth day. SOFA score ranges from 0\\~24, the higher the score, the poorer the functionality of multiple organs.'}], 'secondaryOutcomes': [{'measure': 'AUC - SOFA', 'timeFrame': 'from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the first dose)', 'description': 'Area under the SOFA-time curve'}, {'measure': 'Clinical Outcomes - Incidence of tracheotomy', 'timeFrame': 'from the entry of ICU(baseline, post-operatively) to the 28th day after surgery', 'description': 'Incidence of tracheotomy'}, {'measure': 'Clinical Outcomes - Re-intubation rate', 'timeFrame': 'from the entry of ICU(baseline, post-operatively) to the 28th day after surgery', 'description': 'Re-intubation rate'}, {'measure': 'Clinical Outcomes - Gastrointestinal bleeding （count, rate）', 'timeFrame': 'from the entry of ICU(baseline, post-operatively) to the 28th day after surgery', 'description': 'Gastrointestinal bleeding （count, rate）'}, {'measure': 'Clinical Outcomes - Infection', 'timeFrame': 'from the entry of ICU(baseline, post-operatively) to the 28th day after surgery', 'description': 'Infection: Serious infections such as bloodstream infections, sepsis, ventilator-associated pneumonia'}, {'measure': 'Clinical Outcomes - In-hospital mortality', 'timeFrame': 'from the entry of ICU(baseline, post-operatively) to the 28th day after surgery', 'description': 'In-hospital mortality'}, {'measure': 'Clinical Outcomes - ICU length of stay (days)', 'timeFrame': 'from the entry of ICU(baseline, post-operatively) to the 28th day after surgery', 'description': 'ICU length of stay (days)'}, {'measure': 'Clinical Outcomes - Total hospital length of stay (days)', 'timeFrame': 'from the entry of ICU(baseline, post-operatively) to the 28th day after surgery', 'description': 'Total hospital length of stay (days)'}, {'measure': 'Clinical Outcomes - Ventilator-free days at day 28 (days)', 'timeFrame': 'from the entry of ICU(baseline, post-operatively) to the 28th day after surgery', 'description': 'Mechanical ventilation includes: invasive mechanical ventilation and non-invasive mechanical ventilation'}, {'measure': 'Clinical Outcomes - Invasive ventilatory support duration at day 28 (days)', 'timeFrame': 'from the entry of ICU(baseline, post-operatively) to the 28th day after surgery', 'description': 'Invasive ventilatory support: invasive mechanical ventilation'}, {'measure': 'Clinical Outcomes - Respiratory-support-free time at day 28 (days)', 'timeFrame': 'from the entry of ICU(baseline, post-operatively) to the 28th day after surgery', 'description': 'Respiratory support includes: invasive mechanical ventilation, non-invasive mechanical ventilation, and high-flow oxygen'}, {'measure': 'Clinical Outcomes - Organ-support-free days at day 28(days)', 'timeFrame': 'from the entry of ICU(baseline, post-operatively) to the 28th day after surgery', 'description': 'days free of mechanical ventilation, vasopressors, and renal-replacement therapy'}, {'measure': 'Clinical Outcomes - Central nervous system complications during ICU stay', 'timeFrame': 'from the entry of ICU(baseline, post-operatively) to the 28th day after surgery', 'description': 'Central nervous system complications during ICU stay: cerebral infarction, intracranial hemorrhage, hypoxic-ischemic encephalopathy'}, {'measure': 'Clinical Outcomes - Delirium incidence during ICU stay', 'timeFrame': 'from the entry of ICU(baseline, post-operatively) to the 28th day after surgery', 'description': 'Delirium incidence during ICU stay'}, {'measure': 'Clinical Outcomes - Incidence of acute kidney injury (AKI)', 'timeFrame': 'from the entry of ICU(baseline, post-operatively) to the 28th day after surgery', 'description': 'Incidence of acute kidney injury (AKI)'}, {'measure': 'Laboratory Test Results - Arterial blood gas: pH', 'timeFrame': 'from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment)', 'description': 'pH result from arterial blood gas'}, {'measure': 'Laboratory Test Results - Arterial blood gas: PaO₂/FiO₂', 'timeFrame': 'from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment)', 'description': 'PaO₂/FiO₂ result from arterial blood gas'}, {'measure': 'Laboratory Test Results - Arterial blood gas: SpO₂/FiO₂', 'timeFrame': 'from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment)', 'description': 'SpO₂/FiO₂ result from arterial blood gas'}, {'measure': 'Laboratory Test Results - Arterial blood gas: PaO₂', 'timeFrame': 'from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment)', 'description': 'PaO₂ result from arterial blood gas'}, {'measure': 'Laboratory Test Results - Arterial blood gas: PaCO₂', 'timeFrame': 'from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment)', 'description': 'PaCO₂ result from arterial blood gas'}, {'measure': 'Laboratory Test Results - Arterial blood gas: SpO₂', 'timeFrame': 'from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment)', 'description': 'SpO₂ result from arterial blood gas'}, {'measure': 'Laboratory Test Results - Arterial blood gas: lactate', 'timeFrame': 'from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment)', 'description': 'lactate result from arterial blood gas'}, {'measure': 'Laboratory Test Results - Liver & kidney function: AST', 'timeFrame': 'from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment)', 'description': 'AST from Liver \\& kidney function'}, {'measure': 'Laboratory Test Results - Liver & kidney function: ALT', 'timeFrame': 'from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment)', 'description': 'ALT from Liver \\& kidney function'}, {'measure': 'Laboratory Test Results - Liver & kidney function: ALP', 'timeFrame': 'from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment)', 'description': 'ALP from Liver \\& kidney function'}, {'measure': 'Laboratory Test Results - Liver & kidney function: GGT', 'timeFrame': 'from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment)', 'description': 'GGT from Liver \\& kidney function'}, {'measure': 'Laboratory Test Results - Liver & kidney function: TBil', 'timeFrame': 'from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment)', 'description': 'TBil from Liver \\& kidney function'}, {'measure': 'Laboratory Test Results - Liver & kidney function: DBIL', 'timeFrame': 'from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment)', 'description': 'DBIL from Liver \\& kidney function'}, {'measure': 'Laboratory Test Results - Liver & kidney function: ALB', 'timeFrame': 'from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment)', 'description': 'ALB from Liver \\& kidney function'}, {'measure': 'Laboratory Test Results - Liver & kidney function: Scr', 'timeFrame': 'from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment)', 'description': 'Scr from Liver \\& kidney function'}, {'measure': 'Laboratory Test Results - Liver & kidney function: BUN', 'timeFrame': 'from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment)', 'description': 'BUN from Liver \\& kidney function'}, {'measure': 'Laboratory Test Results - Liver & kidney function: eGFR', 'timeFrame': 'from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment)', 'description': 'eGFR from Liver \\& kidney function'}, {'measure': 'Laboratory Test Results - Liver & kidney function: NGAL', 'timeFrame': 'from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment)', 'description': 'NGAL from Liver \\& kidney function'}, {'measure': 'Laboratory Test Results - Myocardial injury: CK-MB', 'timeFrame': 'from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment)', 'description': 'CK-MB from Myocardial injury'}, {'measure': 'Laboratory Test Results - Myocardial injury: LDH', 'timeFrame': 'from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment)', 'description': 'LDH from Myocardial injury'}, {'measure': 'Laboratory Test Results - Myocardial injury: cTnI or cTnT', 'timeFrame': 'from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment)', 'description': 'cTnI or cTnT from Myocardial injury'}, {'measure': 'Laboratory Test Results - Myocardial injury: BNP or NT-proBNP', 'timeFrame': 'from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment)', 'description': 'BNP or NT-proBNP from Myocardial injury'}, {'measure': 'Laboratory Test Results - Brain injury: NSE', 'timeFrame': 'from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment)', 'description': 'NSE result from blood test, Brain injury part'}, {'measure': 'Laboratory Test Results - Inflammation: CRP', 'timeFrame': 'from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment)', 'description': 'CRP result from Inflammation test'}, {'measure': 'Laboratory Test Results - Inflammation: PCT', 'timeFrame': 'from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment)', 'description': 'PCT result from Inflammation test'}, {'measure': 'Laboratory Test Results - Inflammation: IL-6', 'timeFrame': 'from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment)', 'description': 'IL-6 result from Inflammation test8'}, {'measure': 'Laboratory Test Results - Inflammation: IL-8', 'timeFrame': 'from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment)', 'description': 'IL-8 result from Inflammation test'}, {'measure': 'Laboratory Test Results - Inflammation: IL-10', 'timeFrame': 'from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment)', 'description': 'IL-10 result from Inflammation test'}, {'measure': 'Laboratory Test Results - Inflammation: TNF-α', 'timeFrame': 'from the entry of ICU(baseline, post-operatively) to the fifth day in ICU(the fifth day after the start of treatment)', 'description': 'TNF-α result from Inflammation test'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Type A Aortic Dissection', 'SOFA', 'Sivelestat Sodium', 'Multiple Organ Failure'], 'conditions': ['Type A Aortic Dissection', 'Organ Failure, Multiple']}, 'descriptionModule': {'briefSummary': 'The goal of this multicenter, double-blind, randomized controlled trial is to learn if sivelestat sodium (Siv) can protect the organ function in patients suffered operation for acute type A aortic dissection. The main questions it aims to answer are:\n\n* Can the 3-day-treatment of Siv enlarge the Day-0-to-Day-5 drop in the organ-health score (SOFA score)?\n* Can this treatment significantly shrink the area under the SOFA curve from first dose to Day 5?\n* Can this treatment significantly improve the end of patients in 28 days (clinical outcomes)? Researchers will compare drug Siv to a placebo (a look-alike substance that contains no drug) to see if drug Siv works.\n\nParticipants will:\n\n* Take drug Siv or the placebo through vein continuously for 72 hours\n* Receiving regular intensive care in ICU after the operation'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 18-75 years inclusive.\n2. Written informed consent obtained before participation.\n3. Confirmed acute Stanford type A aortic dissection scheduled for surgical repair.\n\nExclusion Criteria:\n\n1. Life expectancy ≤ 48 hours.\n2. Pregnant or lactation.\n3. Severe pre-operative liver dysfunction: Child-Turcotte-Pugh score 10-15.\n4. Severe pre-operative renal dysfunction: acute or chronic kidney injury meeting criteria for renal-replacement therapy.\n5. Confirmed COPD or asthma.\n6. Immunosuppression: long-term or \\> 2 weeks continuous systemic corticosteroids.\n7. Concomitant or anticipated use of immunomodulators (Xue-Bi-Jing injection, thymosin, IVIG).\n8. Medical or psychological condition that would interfere with study participation, assessment, or outcomes.'}, 'identificationModule': {'nctId': 'NCT07156656', 'acronym': 'STOP', 'briefTitle': 'Sivelestat Treatment for Postoperative Organ Protection in Type A Aortic Dissection', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Zhongshan Hospital'}, 'officialTitle': 'Assessment of the Efficacy of Sivelestat Sodium Treatment in Post-operative Organ Dysfunction in Patients With Acute Type A Aortic Dissection (STOP): a Multicenter, Double-blind RCT', 'orgStudyIdInfo': {'id': 'B2025-349R'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sivelestat group', 'description': 'Drug: Sivelestat Sodium. Procedure: Conventional Treatment', 'interventionNames': ['Procedure: Conventional treatment', 'Drug: Sivelestat sodium']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'Drug: Placebo. Procedure: Conventional Treatment', 'interventionNames': ['Procedure: Conventional treatment', 'Drug: Placebo']}], 'interventions': [{'name': 'Conventional treatment', 'type': 'PROCEDURE', 'description': "Beside the using of Sivelestat Sodium or placebo, all postoperative care will adhere to each center's standard protocols for type A aortic dissection.", 'armGroupLabels': ['Control group', 'Sivelestat group']}, {'name': 'Sivelestat sodium', 'type': 'DRUG', 'otherNames': ['Siv'], 'description': 'The daily dose (4.8 mg/kg) is diluted in 48 mL of 0.9 % saline and administered as a continuous intravenous infusion over 24 hours at 2 mL/h (equivalent to 0.2 mg/kg/h) for 72 consecutive hours.', 'armGroupLabels': ['Sivelestat group']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'An equal volume of placebo-containing only the excipients of sivelestat sodium and diluted to 48 mL with 0.9 % saline-will be infused at 2 mL/h for 72 consecutive hours.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hefei', 'state': 'Anhui', 'country': 'China', 'contacts': [{'name': 'Qian Gong', 'role': 'CONTACT', 'phone': '86 + 18226616000'}], 'facility': 'The First Affiliated Hospital of Anhui Medical University', 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}, {'city': 'Fuzhou', 'state': 'Fujian', 'country': 'China', 'contacts': [{'name': 'Han Chen', 'role': 'CONTACT', 'phone': '86 + 18695770932'}], 'facility': 'Fujian Provincial Hospital', 'geoPoint': {'lat': 26.06139, 'lon': 119.30611}}, {'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'contacts': [{'name': 'Liming Lei', 'role': 'CONTACT', 'phone': '86 + 18688906579'}], 'facility': "Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences) (Guangdong Provincial People's Hospital Affiliated to Southern Medical University)", 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Shenzhen', 'state': 'Guangdong', 'country': 'China', 'contacts': [{'name': 'Peijun Li', 'role': 'CONTACT', 'phone': '86 + 18002093166'}], 'facility': 'The University of Hong Kong - Shenzhen Hospital', 'geoPoint': {'lat': 22.54554, 'lon': 114.0683}}, {'city': "Xi'an", 'state': 'Shaanxi', 'country': 'China', 'contacts': [{'name': 'Tao Shi', 'role': 'CONTACT', 'phone': '86 + 13891881699'}], 'facility': "The First Affiliated Hospital of Xi'an Jiao Tong University", 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}, {'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'contacts': [{'name': 'Bailing Li', 'role': 'CONTACT', 'phone': '86 + 13601973040'}], 'facility': 'Changhai Hospital of Shanghai', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Guowei Tu', 'role': 'CONTACT', 'email': 'tu.guowei@zs-hospital.sh.cn', 'phone': '86 + 13501996995'}, {'name': 'Chenxu Lin', 'role': 'CONTACT', 'email': 'chenxu_lin@163.com', 'phone': '86 + 18016402139'}], 'overallOfficials': [{'name': 'Zhe Luo', 'role': 'STUDY_CHAIR', 'affiliation': 'Fudan University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Zhongshan Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'The First Affiliated Hospital of Anhui Medical University', 'class': 'OTHER'}, {'name': 'Fujian Provincial Hospital', 'class': 'OTHER'}, {'name': 'The University of Hong Kong-Shenzhen Hospital', 'class': 'OTHER'}, {'name': "First Affiliated Hospital Xi'an Jiaotong University", 'class': 'OTHER'}, {'name': "Guangdong Provincial People's Hospital", 'class': 'OTHER'}, {'name': 'Changhai Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}