Ignite Creation Date:
2025-12-24 @ 10:51 PM
Ignite Modification Date:
2025-12-25 @ 8:20 PM
Study NCT ID:
NCT01518569
Status:
COMPLETED
Last Update Posted:
2012-01-26
First Post:
2012-01-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ulinastatin's Anti-inflammatory Reaction in Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C028665', 'term': 'urinastatin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-01-25', 'studyFirstSubmitDate': '2012-01-20', 'studyFirstSubmitQcDate': '2012-01-25', 'lastUpdatePostDateStruct': {'date': '2012-01-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-01-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'bactericidal permeability increasing protein', 'timeFrame': '5-30 min before the end of anesthesia'}, {'measure': 'interleukin-6', 'timeFrame': '5-30 min before the end of anesthesia'}, {'measure': 'tumor necrosis factorTNF-α', 'timeFrame': '5-30 min before the end of anesthesia'}], 'secondaryOutcomes': [{'measure': 'Creatine kinase-MB', 'timeFrame': 'before anesthesia, 24 hour after the end of anesthesia'}, {'measure': 'troponin I', 'timeFrame': 'before anesthesia, 24 hour after the end of anesthesia'}, {'measure': 'C-reactive protein', 'timeFrame': 'before anesthesia, 24 hour after the end of anesthesia'}, {'measure': 'serum creatinine', 'timeFrame': 'before anesthesia, 24 hour after the end of anesthesia'}, {'measure': 'PaO2/FiO2 ratio', 'timeFrame': 'before anesthesia, 24 hour after the end of anesthesia'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['ulinastatin', 'systemic inflammation', 'cardiac surgery', 'cardiopulmonary bypass'], 'conditions': ['Cardiovascular Disease']}, 'referencesModule': {'references': [{'pmid': '16540949', 'type': 'BACKGROUND', 'citation': 'Nakanishi K, Takeda S, Sakamoto A, Kitamura A. Effects of ulinastatin treatment on the cardiopulmonary bypass-induced hemodynamic instability and pulmonary dysfunction. Crit Care Med. 2006 May;34(5):1351-7. doi: 10.1097/01.CCM.0000215110.55899.AE.'}, {'pmid': '9583572', 'type': 'BACKGROUND', 'citation': 'Hill GE. Cardiopulmonary bypass-induced inflammation: is it important? J Cardiothorac Vasc Anesth. 1998 Apr;12(2 Suppl 1):21-5.'}]}, 'descriptionModule': {'briefSummary': "The purpose of the present study is to determine whether ulinastatin, urinary anti-trypsin inhibitor, attenuates cardiopulmonary bypass (CPB)-activated systemic inflammatory response in cardiac surgery with CPB.\n\nSerial measurements and analysis of several inflammatory cytokines (bactericidal permeability increasing protein, interleukin-6, tumor necrosis factor-α)as well as markers of cardiac injury, renal impairment and oxygenation profile will be performed to determine ulinastatin's efficacy.", 'detailedDescription': "Applying aortic cross-clamp (ACC) and cardiopulmonary bypass (CPB) for cardiac surgery produces variable systemic inflammatory reactions. As a common complication of those reactions, pulmonary dysfunction, which usually indicated by postoperative hypoxemia, is frequently associated with cardiac surgery employing CPB and has been used as a major predictor of morbidity and mortality.\n\nCirculating humoral and cellular factors are involved in the development of the systemic inflammatory reactions including organ dysfunction. So far, many studies analyzed the concentration of inflammatory marker (cytokine) to determine the degree of systemic inflammatory responses in various conditions.\n\nUlinastatin has anti-inflammatory activity and suppresses the infiltration of neutrophils. Previous studies suggested ulinastatin's cytoprotective effect against ischemia-reperfusion injury in major organs and its inhibition of inflammatory marker production.\n\nThe purpose of the present study is to determine ulinastatin's possible protective efficacy of in attenuating CPB-activated systemic inflammatory response regarding postoperative cardiac, renal and pulmonary dysfunction in cardiac surgery with CPB. Serial measurements and analysis of several inflammatory cytokines, such as bactericidal permeability increasing protein (BPI), interleukin (IL)-6, tumor necrosis factor (TNF)-α, as well as markers of cardiac injury, renal impairment and oxygenation profile, such as creatine kinase-MB (CK-MB), troponin I (TnI), C-reactive protein (CRP), arterial O2 tension /inspired O2 fraction (PaO2/FiO2 ratio), will be performed to this purpose."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* elective cardiac surgery employing CPB\n\nExclusion Criteria:\n\n* urgent/emergency surgery,\n* previous heart surgery,\n* combined CABG and valve surgery,\n* age \\> 75 yrs,\n* left ventricular ejection fraction \\< 0.45,\n* diabetes treated with insulin,\n* active gastropathic disorder,\n* treatment for chronic obstructive pulmonary disease,\n* preoperative use of steroids\n* postoperative re-operation due to bleeding control\n* pre and postoperative renal replacement therapy\n* left ventricular assist device implantation'}, 'identificationModule': {'nctId': 'NCT01518569', 'acronym': 'ulistin', 'briefTitle': "Ulinastatin's Anti-inflammatory Reaction in Cardiac Surgery", 'organization': {'class': 'OTHER', 'fullName': 'Konkuk University Medical Center'}, 'officialTitle': 'Effect of Ulinastatin on Postoperative Systemic Inflammatory Response in Cardiac Surgery', 'orgStudyIdInfo': {'id': 'KUH1160040'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'normal saline, same amount, iv', 'interventionNames': ['Drug: placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ulinastatin', 'description': '5000 unit/kg iv', 'interventionNames': ['Drug: ulinastatin']}], 'interventions': [{'name': 'ulinastatin', 'type': 'DRUG', 'otherNames': ['ulistin'], 'description': 'ulinastatin 5000 unit/kg iv before the initiation of CPB', 'armGroupLabels': ['ulinastatin']}, {'name': 'placebo', 'type': 'DRUG', 'otherNames': ['normall saline'], 'description': 'placebo (the same amount of normal saline) iv before the initiation of CPB', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '143-729', 'city': 'Seoul', 'state': 'Seoul', 'country': 'South Korea', 'facility': 'Konkuk University Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Konkuk University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Anesthesiology', 'investigatorFullName': 'Tae-Yop Kim, MD PhD', 'investigatorAffiliation': 'Konkuk University Medical Center'}}}}