Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2026-02-28 @ 3:31 AM
Study NCT ID:
NCT01683734
Status:
UNKNOWN
Last Update Posted:
2015-02-04
First Post:
2012-08-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessing Renal Function in Patients With an Antibiotic Laden Spacer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'lastUpdateSubmitDate': '2015-02-03', 'studyFirstSubmitDate': '2012-08-28', 'studyFirstSubmitQcDate': '2012-09-10', 'lastUpdatePostDateStruct': {'date': '2015-02-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-09-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Development of acute renal insufficiency or acute renal failure measured by changes in laboratory values assessing renal function', 'timeFrame': 'subjects will be followed during the time the antibiotic spacer is in place which is approximately 8 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Infected Total Hip or Knee Arthroplasty']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to monitor the renal function of patients who have an antibiotic laden spacer in place to treat an infected hip or knee arthroplasty.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients with an infected hip or knee arthroplasty scheduled to undergo a 2-stage resection surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. All patients undergoing a hip or knee resection arthroplasty by the primary investigator\n2. Ages 18+\n3. Ability to adhere to follow up schedule\n\nExclusion Criteria:\n\n1. Unable to give informed consent\n2. Age \\<18\n3. Previous history of infected Total Knee Arthroplasty or Total Hip Arthroplasty\n4. History of renal failure or impaired renal function\n5. Allergies to aminoglycosides or Vancomycin'}, 'identificationModule': {'nctId': 'NCT01683734', 'briefTitle': 'Assessing Renal Function in Patients With an Antibiotic Laden Spacer', 'organization': {'class': 'OTHER', 'fullName': 'Central DuPage Hospital'}, 'officialTitle': 'Nephrotoxicity Following 2-Stage Exchange With Associated Antibiotic Laden Spacer in Patients With Infected Total Hip/Knee Arthroplasty', 'orgStudyIdInfo': {'id': 'Nephro11-021-1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Renal Function Observation'}]}, 'contactsLocationsModule': {'locations': [{'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'RUSH University Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60190', 'city': 'Winfield', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Scott Sporer, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Central DuPage Hospital', 'geoPoint': {'lat': 41.8617, 'lon': -88.1609}}], 'centralContacts': [{'name': 'Stefanie Miller, BS', 'role': 'CONTACT', 'email': 'Stefanie.Miller@CadenceHealth.org', 'phone': '630-933-6254'}, {'name': 'Judy Guerreiro, RN', 'role': 'CONTACT', 'email': 'Judy.Guerreiro@CadenceHealth.org', 'phone': '630-933-2941'}], 'overallOfficials': [{'name': 'Scott Sporer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'RUSH University Medical Center; Central DuPage Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central DuPage Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}