Ignite Creation Date:
2025-12-24 @ 5:33 PM
Ignite Modification Date:
2025-12-24 @ 5:33 PM
Study NCT ID:
NCT04433468
Status:
COMPLETED
Last Update Posted:
2022-07-01
First Post:
2020-06-11
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study on the Protective Effect of RIPC in Patients Undergoing Cardiac Surgery.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-09-12', 'releaseDate': '2024-04-18'}], 'estimatedResultsFirstSubmitDate': '2024-04-18'}}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2021-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-28', 'studyFirstSubmitDate': '2020-06-11', 'studyFirstSubmitQcDate': '2020-06-15', 'lastUpdatePostDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The incidence of acute renal injury after operation', 'timeFrame': 'within 7 days after operation', 'description': 'According to the (KDIGO) guidelines for improving the prognosis of renal disease'}, {'measure': 'The incidence of postoperative delirium', 'timeFrame': 'within 7 days after operation', 'description': 'CAM score greater than 22'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cardiac Surgery']}, 'descriptionModule': {'briefSummary': 'To observe the effect of RIPC on the function of vital organs after cardiac surgery, and to explore its possible mechanism.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with aortic valve, mitral valve, tricuspid valve, ascending aortic disease and coronary atherosclerosis who were admitted to hospital for elective valve repair, replacement, artificial vascular replacement or coronary artery bypass grafting.\n* age 18-80 years old.\n* No restriction on gender.\n* ASA grade II\\~III.\n* NYHAII\\~III level.\n* the patient or his family member has signed the informed consent form for the clinical trial\n\nExclusion Criteria:\n\n* those who are disabled in the selected test.\n* less than 5 years of education.\n* The preoperative left ventricular ejection fraction ((LVEF)) was less than 40%.\n* Myocardial infarction occurred in nearly one month.\n* malignant tumor, hematological disease, severe liver and kidney dysfunction, recent severe infection, etc.\n* History of nervous system, immune system and mental illness.\n* recent operation history of heart, brain, lung, liver, kidney and other important organs'}, 'identificationModule': {'nctId': 'NCT04433468', 'briefTitle': 'Study on the Protective Effect of RIPC in Patients Undergoing Cardiac Surgery.', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai Zhongshan Hospital'}, 'officialTitle': 'Study on the Protective Effect of RIPC in Patients Undergoing Cardiac Surgery.', 'orgStudyIdInfo': {'id': '2020RIPC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'RIPC', 'interventionNames': ['Device: RIPC']}, {'type': 'NO_INTERVENTION', 'label': 'Control'}], 'interventions': [{'name': 'RIPC', 'type': 'DEVICE', 'description': 'The tourniquet attached to the upper limb was inflated and blocked for 5 minutes, then deflated for 5 minutes to restore blood flow and induce ischemic preconditioning.', 'armGroupLabels': ['RIPC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'country': 'China', 'facility': '180 Fenglin Road', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Zhongshan Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2024-04-18', 'type': 'RELEASE'}, {'date': '2024-09-12', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Shanghai Zhongshan Hospital'}}}}