Ignite Creation Date:
2025-12-25 @ 4:18 AM
Ignite Modification Date:
2026-02-21 @ 10:37 PM
Study NCT ID:
NCT02029820
Status:
UNKNOWN
Last Update Posted:
2014-01-08
First Post:
2014-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
RenalGuard System for Prevention of Contrast Induced Nephropathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 210}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-01-06', 'studyFirstSubmitDate': '2014-01-06', 'studyFirstSubmitQcDate': '2014-01-06', 'lastUpdatePostDateStruct': {'date': '2014-01-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-01-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of contrast-induced nephropathy', 'timeFrame': '72 hours', 'description': 'Contrast-induced nephropathy defined as an increase of serum creatinine of 0.5mg/dl or 25% in pre procedure serum creatinine at 72h after procedure'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Contrast Nephropathy', 'Prevention', 'Renalguard'], 'conditions': ['Radiographic Contrast Agent Nephropathy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether hydration with intravenous saline matched with urine output, using the device RenalGuard is superior to standard hydration with saline to prevent contrast-induced nephropathy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* serum creatinine \\>1.2mg/dl\n* glomerular filtration rate (GFR) \\< 60ml/min\n\nExclusion Criteria:\n\n* acute renal failure\n* use of radiological contrast in the latest 7 days\n* Current use of N-acetylcysteine or hydration of sodium bicarbonate\n* Patients in dialysis\n* Emergency procedures'}, 'identificationModule': {'nctId': 'NCT02029820', 'acronym': 'REPRECIN', 'briefTitle': 'RenalGuard System for Prevention of Contrast Induced Nephropathy', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Sao Lucas da PUCRS'}, 'officialTitle': 'RenalGuard System for Prevention of Contrast Induced Nephropathy - A Randomized Trial', 'orgStudyIdInfo': {'id': '11/05339'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'RenalGuard', 'description': 'Hydration with the device renalguard', 'interventionNames': ['Device: RenalGuard']}, {'type': 'NO_INTERVENTION', 'label': 'Saline', 'description': 'Hydration with saline 1ml/Kg/h for 12h'}], 'interventions': [{'name': 'RenalGuard', 'type': 'DEVICE', 'description': 'Intravenous saline hydration matched with urine output, using the device Renalguard', 'armGroupLabels': ['RenalGuard']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90610-000', 'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Aryadina Piva, RN', 'role': 'CONTACT', 'email': 'pesquisa@cardiarte.com.br', 'phone': '55 51 3320 3494'}, {'name': 'Vitor O Gomes, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital São Lucas -PUCRS, Serviço de Hemodinâmica', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}], 'centralContacts': [{'name': 'Aryadina Piva, RN', 'role': 'CONTACT', 'email': 'pesquisa@cardiarte.com.br', 'phone': '55 51 33203494'}], 'overallOfficials': [{'name': 'Vitor O Gomes, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Sao Lucas'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Sao Lucas da PUCRS', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Vitor Osorio Gomes', 'investigatorAffiliation': 'Hospital Sao Lucas da PUCRS'}}}}