Ignite Creation Date:
2025-12-24 @ 10:59 PM
Ignite Modification Date:
2026-02-21 @ 9:56 PM
Study NCT ID:
NCT01476969
Status:
UNKNOWN
Last Update Posted:
2012-08-14
First Post:
2011-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Remote Ischemic Perconditioning on Acute Kidney Injury in Adult Valve Replace
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015427', 'term': 'Reperfusion Injury'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2012-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-08-11', 'studyFirstSubmitDate': '2011-11-16', 'studyFirstSubmitQcDate': '2011-11-18', 'lastUpdatePostDateStruct': {'date': '2012-08-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-11-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Renal function', 'timeFrame': 'within the first 48h after cardiac surgery'}], 'secondaryOutcomes': [{'measure': 'concentration of troponin I (cTnI)', 'timeFrame': 'within 48h after cardiac surgery'}, {'measure': 'Myocardial enzyme', 'timeFrame': 'within 48h after cardiac surgery'}, {'measure': 'Cystatin C', 'timeFrame': 'within 48h after cardiac surgery'}, {'measure': 'High-sensitivity c-reactive protein(HS-CRP)', 'timeFrame': 'within 48h after cardiac surgery'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Ischemia reperfusion injury', 'Cardiopulmonary bypass', 'Remote Ischemic Postconditioning', 'Other Functional Disturbances Following Cardiac Surgery'], 'conditions': ['Rheumatic Disease of Heart Valve', 'Ischemic Reperfusion Injury']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether Remote Ischemic Perconditioning is effective on Acute kidney injury in adult valve replacement.', 'detailedDescription': 'Methods: Patients meeting the requirement will be randomized into 2 groups: the treatment group consisted of three 5-minute cycles left lower limb ischemia, induced by inflating a blood pressure cuff on the lower limb to 600 mmHg with an intervening 5 minutes of reperfusion, during which time the cuff was deflate; the control group consisted of placing an uninflated cuff on the left lower limb for 30 minutes. The postconditioning protocol was applied after the aortic cross-clamping. The clinical data of inotropes requirement, drainage, ventilation and intensive care time will be recorded. Venous blood samples will be taken perioperatively for detecting concentration of troponin I (cTnI), Myocardial enzyme, Renal function, Cystatin c, and High-sensitivity c-reactive protein(HS-CRP).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* rheumatic heart valve disease requiring selective aortic or double valve(aortic and mitral valve) replacement\n\nExclusion Criteria:\n\n* infective endocarditis congenital valve disease previous cardiac surgery complicated with rereplace valve\n* Renal dysfunction\n* diabetes\n* coronary artery disease\n* hypertension\n* peripheral vascular disease affecting the lower limb free of arteriovenous fistula\n* receiving aspirin, corticosteroids, angiotensin-converting enzyme inhibitors or statin perioperatively'}, 'identificationModule': {'nctId': 'NCT01476969', 'briefTitle': 'Effect of Remote Ischemic Perconditioning on Acute Kidney Injury in Adult Valve Replace', 'organization': {'class': 'OTHER', 'fullName': 'Central South University'}, 'officialTitle': 'Effect of Remote Ischemic Perconditioning on Acute Kidney Injury in Adult Valve Replace', 'orgStudyIdInfo': {'id': 'CentralSouthU'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Manual Tourniquet', 'interventionNames': ['Device: Remote ischemic postconditioning']}], 'interventions': [{'name': 'Remote ischemic postconditioning', 'type': 'DEVICE', 'otherNames': ['Manual Tourniquet YZ-01'], 'description': 'the treatment group consisted of three 4-minute cycles left lower limb ischemia,induced by inflating a blood pressure cuff on the lower limb to 600 mmHg with an intervening 4 minutes of reperfusion ,during which time the cuff was deflate;the control group consisted of placing an uninflated cuff on the left lower limb for 24 minutes.The postconditioning protocol was applied after the aortic cross-clamping.', 'armGroupLabels': ['Manual Tourniquet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '410008', 'city': 'Changsha', 'state': 'Hunan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Luo Wanjun, M.D.', 'role': 'CONTACT', 'email': 'luo3478@yahoo.cn', 'phone': '86-731-89753503'}, {'name': 'Lv Hongwei, M.D.', 'role': 'CONTACT', 'email': 'hongweilv@163.com', 'phone': '86-13467616975'}, {'name': 'Luo Wanjun, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Lv Hongwei, M.D.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Central South University', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}], 'centralContacts': [{'name': 'Luo Wanjun, M.D.', 'role': 'CONTACT', 'email': 'luo3478@yahoo.cn', 'phone': '86-731-89753503'}, {'name': 'Lv Hongwei, M.D.', 'role': 'CONTACT', 'email': 'hongweilv@163.com', 'phone': '86-13467616975'}], 'overallOfficials': [{'name': 'Luo Wanjun, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Central South University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central South University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Luo Wanjun', 'investigatorAffiliation': 'Central South University'}}}}