Ignite Creation Date:
2025-12-24 @ 5:18 PM
Ignite Modification Date:
2025-12-25 @ 2:55 PM
Study NCT ID:
NCT06707350
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-11-27
First Post:
2024-11-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Protective Effect of RIPC Against Negative Inflammatory Response and Organ Dysfunction After Cardiovascular Surgery (Panda VII)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, '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': 500}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-24', 'studyFirstSubmitDate': '2024-11-24', 'studyFirstSubmitQcDate': '2024-11-24', 'lastUpdatePostDateStruct': {'date': '2024-11-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '∆SOFA', 'timeFrame': 'within the prior 7 days after cardiac surgery.', 'description': 'the change in sequential organ failure assessment score \\[∆SOFA\\]) was defined as the difference between the mean total postoperative SOFA score, calculated maximally to the 9th postoperative day, and the basal SOFA score.'}], 'secondaryOutcomes': [{'measure': 'Plasma interleukin-1 levels', 'timeFrame': 'within the prior 7 days after cardiac surgery.', 'description': 'Plasma interleukin-1 levels within the prior 7 days after cardiac surgery.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['inflammation'], 'conditions': ['Cardiopulmonary Bypass', 'Cardiovascular Diseases', 'Inflammatory Response During Cardiac Surgery']}, 'referencesModule': {'references': [{'pmid': '39319450', 'type': 'BACKGROUND', 'citation': 'Jia P, Ji Q, Zou Z, Zeng Q, Ren T, Chen W, Yan Z, Shen D, Li Y, Peng F, Su Y, Xu J, Shen B, Luo Z, Wang C, Ding X. Effect of Delayed Remote Ischemic Preconditioning on Acute Kidney Injury and Outcomes in Patients Undergoing Cardiac Surgery: A Randomized Clinical Trial. Circulation. 2024 Oct 22;150(17):1366-1376. doi: 10.1161/CIRCULATIONAHA.124.071408. Epub 2024 Sep 25.'}]}, 'descriptionModule': {'briefSummary': 'Remote ischaemic pre-conditioning (RIPC) has been recognized as a low-cost, non-invasive intervention method by applying brief ischaemia and reperfusion on an arm or a leg. Previous studies have mainly focused on the organoprotective effects of RIPC in patients undergoing cardiac surgery. However, whether it has an organ-protecting effect is still highly debated. We aimed to determine whether intensive RIPC can prevent from negative inflammatory response and organ dysfunction as well as postoperative complications in patients undergoing cardiovascular surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients at high risk for organ dysfunctions who underwent elective cardiovascular surgery requiring cardiopulmonary bypass (CPB);\n* age of 18 -80 years old, regardless of gender;\n* subjects voluntarily participate in the trialand sign the informed consent;\n\nExclusion Criteria:\n\n* 1\\) Arm fracture, skin injury or infection;\n* 2\\) There is limb nerve injury;\n* 3\\) Limb placement PICC, arteriovenous fistula and other devices that affect armband placement;\n* 4\\) There are basic vascular lesions and poor blood supply at the extremities;\n* 5\\) Limb thrombosis.'}, 'identificationModule': {'nctId': 'NCT06707350', 'acronym': 'PANDA', 'briefTitle': 'Protective Effect of RIPC Against Negative Inflammatory Response and Organ Dysfunction After Cardiovascular Surgery (Panda VII)', 'organization': {'class': 'OTHER', 'fullName': 'Nanjing Medical University'}, 'officialTitle': 'Protective Effect of Remote Ischemic Preconditioning (RIPC) Against Negative Inflammatory Response and Organ Dysfunction After Cardiovascular Surgery (Panda VII)', 'orgStudyIdInfo': {'id': 'PANDA VII'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RIPC Group', 'description': '6 cycles of 5-minute inflation and 5-minute deflation on 2 upper and lower libms with a blood pressure cuff at 72, 36, 24 hours before surgery', 'interventionNames': ['Device: Remote ischemic preconditioning (RIPC)']}, {'type': 'SHAM_COMPARATOR', 'label': 'Control group', 'description': '8 cycles of 5-minute inflation to a pressure of 20 mm Hg followed by 5-minute cuff deflation on 2 upper and lower libms with a blood pressure cuff at 72, 36, 24 hours before surgery', 'interventionNames': ['Device: sham condition (control group)']}], 'interventions': [{'name': 'Remote ischemic preconditioning (RIPC)', 'type': 'DEVICE', 'description': '8 cycles of 5-minute inflation and 5-minute deflation on 2 upper and lower limbs with a blood pressure cuff', 'armGroupLabels': ['RIPC Group']}, {'name': 'sham condition (control group)', 'type': 'DEVICE', 'description': '8 cycles of 5-minute inflation to a pressure of 20 mm Hg followed by 5-minute cuff deflation.', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210029', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'contacts': [{'name': 'Hong Liu, MD', 'role': 'CONTACT', 'email': 'dr.hongliu@foxmail.com', 'phone': '18801281613'}, {'name': 'Yong-feng Shao, MD', 'role': 'CONTACT', 'email': 'yfshaojph@sina.com', 'phone': '02568303101'}, {'name': 'Hong Liu, MD', 'role': 'CONTACT'}], 'facility': 'The First Affiliated Hospital of Nanjing Medical University', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'centralContacts': [{'name': 'Hong Liu, MD', 'role': 'CONTACT', 'email': 'dr.hongliu@foxmail.com', 'phone': '18801281613'}, {'name': 'Yong-feng Shao, MD', 'role': 'CONTACT', 'email': 'yfshaojph@sina.com', 'phone': '02568303101'}], 'overallOfficials': [{'name': 'Yong-feng Shao, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'The First Affiliated Hospital with Nanjing Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanjing Medical University', 'class': 'OTHER'}, 'collaborators': [{'name': 'The First Affiliated Hospital with Nanjing Medical University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator of China 5A Network', 'investigatorFullName': 'Hong Liu', 'investigatorAffiliation': 'Nanjing Medical University'}}}}