Ignite Creation Date:
2025-12-25 @ 2:29 AM
Ignite Modification Date:
2025-12-26 @ 1:04 AM
Study NCT ID:
NCT01894334
Status:
UNKNOWN
Last Update Posted:
2014-01-24
First Post:
2013-06-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Mechanism and Early Intervention Research on ALI During Emergence Surgery of Acute Stanford A Aortic Dissection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000784', 'term': 'Aortic Dissection'}, {'id': 'D055371', 'term': 'Acute Lung Injury'}], 'ancestors': [{'id': 'D000094665', 'term': 'Dissection, Blood Vessel'}, {'id': 'D000783', 'term': 'Aneurysm'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000094683', 'term': 'Acute Aortic Syndrome'}, {'id': 'D001018', 'term': 'Aortic Diseases'}, {'id': 'D055370', 'term': 'Lung Injury'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C028665', 'term': 'urinastatin'}, {'id': 'D014148', 'term': 'Tranexamic Acid'}, {'id': 'D000077553', 'term': 'Edaravone'}], 'ancestors': [{'id': 'D003509', 'term': 'Cyclohexanecarboxylic Acids'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000983', 'term': 'Antipyrine'}, {'id': 'D047069', 'term': 'Pyrazolones'}, {'id': 'D011720', 'term': 'Pyrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 220}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2015-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-01-23', 'studyFirstSubmitDate': '2013-06-08', 'studyFirstSubmitQcDate': '2013-07-04', 'lastUpdatePostDateStruct': {'date': '2014-01-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-07-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'perioperative outcome and improve of ALI', 'timeFrame': 'Period from 48 hours before surgery to 12 hours after ICU', 'description': 'indicators\n\n* chest imaging (preoperative, 12 hours after ICU);\n* arterial blood gases and alveolar-arterial oxygen difference (before surgery, and immediately after induction of anesthesia, before surgery ends and 12 hours after ICU);\n* respiratory mechanics (immediately after induction of anesthesia, before the end of surgery and 12 hours after ICU); including peak airway pressure, plateau pressure, dynamic and static compliance and so on.'}], 'secondaryOutcomes': [{'measure': 'systemic inflammatory response', 'timeFrame': 'Period from 48 hours before surgery to 12 hours after ICU', 'description': 'Indicators\n\n* Lung lavage (immediately after induction of anesthesia、before the end of surgery)\n* determination of imflammatory cytokines (IL-6, IL-8, Tumor Necrosis Factor -α, Cluster of Differentiation 11 /Cluster of Differentiation 18 , myeloperoxidase) and surface-active substance'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Aortic dissection', 'acute lung injury', 'injury mechanism', 'early intervention'], 'conditions': ['Acute Aortic Dissection']}, 'referencesModule': {'references': [{'pmid': '31179061', 'type': 'DERIVED', 'citation': 'Gao Z, Pei X, He C, Wang Y, Lu J, Jin M, Cheng W. Oxygenation impairment in patients with acute aortic dissection is associated with disorders of coagulation and fibrinolysis: a prospective observational study. J Thorac Dis. 2019 Apr;11(4):1190-1201. doi: 10.21037/jtd.2019.04.32.'}, {'pmid': '30174890', 'type': 'DERIVED', 'citation': 'Pan X, Lu J, Cheng W, Yang Y, Zhu J, Jin M. Independent factors related to preoperative acute lung injury in 130 adults undergoing Stanford type-A acute aortic dissection surgery: a single-center cross-sectional clinical study. J Thorac Dis. 2018 Jul;10(7):4413-4423. doi: 10.21037/jtd.2018.06.140.'}, {'pmid': '27759648', 'type': 'DERIVED', 'citation': 'Cheng Y, Jin M, Dong X, Sun L, Liu J, Wang R, Yang Y, Lin P, Hou S, Ma Y, Wang Y, Pan X, Lu J, Cheng W. Mechanism and early intervention research on ALI during emergence surgery of Stanford type-A AAD: Study protocol for a prospective, double-blind, clinical trial. Medicine (Baltimore). 2016 Oct;95(42):e5164. doi: 10.1097/MD.0000000000005164.'}]}, 'descriptionModule': {'briefSummary': "The morbidity rate of Stanford A type Acute Aortic Dissection（AAD） has been increasing, about 5-10/100,000\\* per year. Emergency surgery has been the main treatment for Acute Aortic Dissection, however perioperative mortality rate can be as high as 15\\~30%. Acute lung injury (ALI) is one of the main complications that happen during the perioperative period, which by itself covers 30%-50% of the overall mortality rate. Both domestic and foreign countries lack researches on risk factors, pathogenesis, disease progression and outcome of ALI, which happen during the perioperative period of Acute Aortic Dissection patients.\n\nThis topic study follow projects in the preoperative of Acute Aortic Dissection'surgery\n\n1. hemodynamic changes (aortic dissection resulting in acute aortic regurgitation, cardiac tamponade and proximal high blood pressure)\n2. ischemia - reperfusion injury of aortic dissection distal organ\n3. Aortic intima-media exposure cause coagulation / fibrinolytic system function disorder\n4. systemic inflammatory response syndrome; use relevant clinical radiographic parameters, indicators of respiratory mechanics (oxygenation index and lung injury index) and biochemical indicators.\n\nTo discuss risk factors and possible mechanisms of ADD patients with pre-operative ALI and observe their influences on the progress and prognosis of AAD, to explore early intervention in the preoperative for possible risk factors and mechanisms and to evaluate their influences on the prognosis, to achieve the purpose of reducing AAD perioperative mortality of ALI and medical expenses."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* AAD patients within 48 hrs of onset who are prepared for aortic surgery\n* Age between 18 and 70\n* Willing to sign the informed consent\n\nExclusion Criteria:\n\n* A history of chronic respiratory disease before onset\n* A history of chronic heart failure or coronary heart disease before onset\n* A history of chronic liver or kidney dysfunction before onset\n* Severe central nervous system syndrome after admission\n* Refuse to sign the informed consent'}, 'identificationModule': {'nctId': 'NCT01894334', 'briefTitle': 'Mechanism and Early Intervention Research on ALI During Emergence Surgery of Acute Stanford A Aortic Dissection', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Anzhen Hospital'}, 'officialTitle': 'Mechanism and Early Intervention Research on Acute Lung Injury During Emergence Surgery of Acute Stanford A Aortic Dissection', 'orgStudyIdInfo': {'id': '2011-2006-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'no intervention'}, {'type': 'EXPERIMENTAL', 'label': 'Tranexamic acid group', 'description': 'tranexamic acid ，intravenous 30mg/kg/d，Preoperative', 'interventionNames': ['Drug: Tranexamic acid']}, {'type': 'EXPERIMENTAL', 'label': 'Edaravone group', 'description': 'edaravone, iv, 1mg/kg/d,Preoperative', 'interventionNames': ['Drug: Edaravone']}, {'type': 'EXPERIMENTAL', 'label': 'Ulinastatin group', 'description': 'Ulinastatin ,iv，20,000 U /kg/d，Preoperative', 'interventionNames': ['Drug: Ulinastatin']}], 'interventions': [{'name': 'Ulinastatin', 'type': 'DRUG', 'armGroupLabels': ['Ulinastatin group']}, {'name': 'Tranexamic acid', 'type': 'DRUG', 'armGroupLabels': ['Tranexamic acid group']}, {'name': 'Edaravone', 'type': 'DRUG', 'armGroupLabels': ['Edaravone group']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'WeiPing Cheng, master', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chief Physician，Professor'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Anzhen Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor；Chief Physician', 'investigatorFullName': 'WeiPing Cheng', 'investigatorAffiliation': 'Beijing Anzhen Hospital'}}}}