Ignite Creation Date:
2025-12-24 @ 6:44 PM
Ignite Modification Date:
2025-12-24 @ 6:44 PM
Study NCT ID:
NCT04016857
Status:
COMPLETED
Last Update Posted:
2021-10-04
First Post:
2019-07-08
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Remote Ischemic Preconditioning During Lower Limb Revascularization
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058186', 'term': 'Acute Kidney Injury'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The RIPC procedure were performed in the ward before going to operating room, and this is blinded to Investigators and surgical case anesthesiologist'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'patients were randomly assigned in 1:1 ratio to either control group or RIPC using computerized randomization table'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2019-06-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-27', 'studyFirstSubmitDate': '2019-07-08', 'studyFirstSubmitQcDate': '2019-07-08', 'lastUpdatePostDateStruct': {'date': '2021-10-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AKI', 'timeFrame': '72 Hours', 'description': 'the incidence of Acute Kidney Injury, defined as absolute rise of ≥ 0.3 mg/dL and/or a relative increase of 25% in serum creatinine compared to preoperative'}, {'measure': 'AKI', 'timeFrame': '72 Hours', 'description': 'the incidence of Acute Kidney Injury, defined as decrease of 35% in GFR compared to preoperative.'}], 'secondaryOutcomes': [{'measure': 'AKI Risk Score', 'timeFrame': '24 Hours', 'description': 'the incidence of Acute Kidney Injury, defined as increase od 0.3 in Aki risk score (TIMP-2 \\* IGFBP-7)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['remote ischemic preconditioning', 'lower limb revascularization', 'TIMP-2', 'IGFBP-7'], 'conditions': ['Ischemic Preconditioning', 'Acute Kidney Injury', 'Limb Ischemia']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the role of remote ischemic preconditioning (RIPC) in preventing acute kidney injury after lower limb revascularization.\n\nRemote ischemic preconditioning(RIPC) is a simple, cost-free and non invasive procedure (transient upper limb ischemia/reperfusion) that could provide organ protection (Heart, Brain and Kidney) following ischemia injuries.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients scheduled for open limb revascularization\n\nExclusion Criteria:\n\n* Peripheral vascular disease affecting upper limbs\n* Chronic kidney disease in stage 4 or 5 (eGFR\\<30 ml/min/1,73m2)\n* Patients underwent contrast-enhanced radiological exams in the previous 7 days\n* Treatment with glibencamide or prostaglandins'}, 'identificationModule': {'nctId': 'NCT04016857', 'briefTitle': 'Remote Ischemic Preconditioning During Lower Limb Revascularization', 'organization': {'class': 'OTHER', 'fullName': 'University of Messina'}, 'officialTitle': 'Effects of Remote Ischemic Preconditioning on Renal Outcomes Following Lower Limb Revascularization', 'orgStudyIdInfo': {'id': 'UMEANE1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RIPC Group', 'description': 'Remote ischemic preconditioning', 'interventionNames': ['Procedure: RIPC']}, {'type': 'SHAM_COMPARATOR', 'label': 'Control Group', 'description': 'Sham remote ischemic preconditioning', 'interventionNames': ['Procedure: Control']}], 'interventions': [{'name': 'RIPC', 'type': 'PROCEDURE', 'description': '4 cycles of 5-min inflation to 200 mmHg followed by 5-min deflation of arm cuff', 'armGroupLabels': ['RIPC Group']}, {'name': 'Control', 'type': 'PROCEDURE', 'description': 'deflated cuff placed on the left arm for 40 min', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98100', 'city': 'Messina', 'country': 'Italy', 'facility': 'A.O.U. G.Martino - University of Messina', 'geoPoint': {'lat': 38.19394, 'lon': 15.55256}}], 'overallOfficials': [{'name': 'Alberto Noto, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Messina'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Messina', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Anaesthesia', 'investigatorFullName': 'Alberto Noto', 'investigatorAffiliation': 'University of Messina'}}}}