Ignite Creation Date:
2025-12-24 @ 10:35 PM
Ignite Modification Date:
2025-12-30 @ 6:03 AM
Study NCT ID:
NCT01925235
Status:
COMPLETED
Last Update Posted:
2013-08-19
First Post:
2013-08-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Analysis of Remote-ischemic Preconditioning Effects on Kidney Function
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007250', 'term': 'Inflation, Economic'}], 'ancestors': [{'id': 'D004467', 'term': 'Economics'}, {'id': 'D004472', 'term': 'Health Care Economics and Organizations'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-08-16', 'studyFirstSubmitDate': '2013-08-15', 'studyFirstSubmitQcDate': '2013-08-16', 'lastUpdatePostDateStruct': {'date': '2013-08-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-08-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in parameters determining renal function and injury', 'timeFrame': '48 hours after TAVI', 'description': 'serum creatinine, cystatin c, urinary neutrophil gelatinase-associated lipocalin (NGAL)'}], 'secondaryOutcomes': [{'measure': 'acute kidney injury', 'timeFrame': '48 hours after TAVI', 'description': 'increase in serum creatinine ≥25% or ≥0.5 mg/dL above baseline at 48 hours after TAVI'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['remote ischemic preconditioning', 'acute kidney injury', 'TAVI', 'RenPRO trial', 'parameters'], 'conditions': ['Renal Function', 'Renal Injury']}, 'referencesModule': {'references': [{'pmid': '22735306', 'type': 'BACKGROUND', 'citation': 'Er F, Nia AM, Dopp H, Hellmich M, Dahlem KM, Caglayan E, Kubacki T, Benzing T, Erdmann E, Burst V, Gassanov N. Ischemic preconditioning for prevention of contrast medium-induced nephropathy: randomized pilot RenPro Trial (Renal Protection Trial). Circulation. 2012 Jul 17;126(3):296-303. doi: 10.1161/CIRCULATIONAHA.112.096370. Epub 2012 Jun 26.'}, {'pmid': '23662313', 'type': 'BACKGROUND', 'citation': 'Er F, Nia AM, Dopp H, Dahlem KM, Caglayan E, Erdmann E, Gassanov N, Hellmich M, Burst V, Kubacki T, Benzing T. Response to letter regarding article, "Ischemic preconditioning for prevention of contrast medium-induced nephropathy: randomized Pilot RenPro-Trial (Renal Protection Trial)". Circulation. 2013 Apr 2;127(13):e536. doi: 10.1161/circulationaha.112.147587. No abstract available.'}], 'seeAlsoLinks': [{'url': 'http://www.cardiovascular-research.org', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'Patients with impaired renal function are at elevated risk for development of acute kidney injury (AKI). AKI is associated with increased risk for cardiovascular morbidity and mortality. Effective AKI prevention strategies are needed. Remote ischemic preconditioning (RIPC) is a novel and successful strategy to attenuate contrast medium induced AKI in patients undergoing elective coronary angiography.\n\nThe retrospective RenPro-TAVI Trial was designed to test the hypothesis whether remote ischemic preconditioning might attenuate kidney injury in patients receiving transcatheter aortic valve implantation (TAVI).\n\nPatients with impaired renal function undergoing TAVI will be evaluated in respect whether they received remote ischemic preconditioning before the procedure or not. This study will give insight if RIPC might be beneficial in these patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients with impaired renal function and a high risk of developing contrast medium-induced acute kidney injury undergoing TAVI', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age \\>= 18 years\n* impaired renal function (baseline eGFR of \\<60 ml/min)\n* high INTEGER risk score \\> 11\n* high EuroSCORE (European system for cardiac operative risk evaluation)\n\nExclusion Criteria:\n\n* severe renal impairment (eGFR \\<15 ml/min and/or in chronic dialysis)\n* recent (\\<=30 days) contrast media exposure\n* patients enrolled in concomitant studies\n* fertile women'}, 'identificationModule': {'nctId': 'NCT01925235', 'acronym': 'RenPRO-TAVI', 'briefTitle': 'Analysis of Remote-ischemic Preconditioning Effects on Kidney Function', 'organization': {'class': 'OTHER', 'fullName': 'University of Cologne'}, 'officialTitle': 'Remote Ischemic Preconditioning Effects on Kidney Function in Patients Receiving Transcatheter Aortic Valve Implantation', 'orgStudyIdInfo': {'id': 'Ren-PRO TAVI retro'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Control', 'description': 'patients with impaired renal function and a high risk of developing acute kidney injury undergoing TAVI and receiving standard care including pre-hydration 12 hours prior and 12 hours post procedure'}, {'label': 'RIPC', 'description': 'patients with impaired renal function and a high risk of developing acute kidney injury undergoing TAVI and receiving standard care including pre-hydration 12 hours prior and 12 hours post procedure plus ischemic preconditioning (intermittent arm ischemia through 4 cycles of 5-minute inflation and 5-minute deflation of a blood pressure cuff)', 'interventionNames': ['Procedure: remote ischemic preconditioning']}], 'interventions': [{'name': 'remote ischemic preconditioning', 'type': 'PROCEDURE', 'otherNames': ['intermittent arm ischemia through 4 cycles of 5-minute inflation and 5-minute deflation of a blood pressure cuff'], 'armGroupLabels': ['RIPC']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50931', 'city': 'Cologne', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'University Hospital of Cologne', 'geoPoint': {'lat': 50.93333, 'lon': 6.95}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Cologne', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Dr. Fikret Er', 'investigatorAffiliation': 'University of Cologne'}}}}