Ignite Creation Date:
2025-12-25 @ 3:16 AM
Ignite Modification Date:
2026-03-03 @ 2:39 AM
Study NCT ID:
NCT03795805
Status:
COMPLETED
Last Update Posted:
2019-01-09
First Post:
2018-12-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
After Surgery Acute Renal Failure Incidence in Total Knee Arthroplasty With and Without Tourniquet
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058186', 'term': 'Acute Kidney Injury'}, {'id': 'D020370', 'term': 'Osteoarthritis, Knee'}], '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'}, {'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019645', 'term': 'Arthroplasty, Replacement, Knee'}, {'id': 'D008012', 'term': 'Lidocaine'}], 'ancestors': [{'id': 'D019643', 'term': 'Arthroplasty, Replacement'}, {'id': 'D001178', 'term': 'Arthroplasty'}, {'id': 'D019637', 'term': 'Orthopedic Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019651', 'term': 'Plastic Surgery Procedures'}, {'id': 'D019919', 'term': 'Prosthesis Implantation'}, {'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized Clinical Trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2018-12-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-07', 'studyFirstSubmitDate': '2018-12-26', 'studyFirstSubmitQcDate': '2019-01-07', 'lastUpdatePostDateStruct': {'date': '2019-01-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Creatinin before surgery', 'timeFrame': 'Creatinin before surgery', 'description': 'Blood Creatinin meassure in mg/dl before surgery'}, {'measure': 'Creatinin after surgery 1', 'timeFrame': 'Creatinin after surgery 1 at 24 hours', 'description': 'Blood Creatinin meassure in mg/dl at 24 hours'}, {'measure': 'Creatinin after surgery 2', 'timeFrame': 'Creatinin after surgery 2 at 48 hours', 'description': 'Blood Creatinin meassure in mg/dl at 48 hours'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Arthroplasty, Replacement, Knee', 'Acute Kidney Injury', 'Tourniquets', 'Knee Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'This study analize the incidence of acute renal failure after performing total knee arthroplasty with or without use of tourniquet limb cuff (half of patients for each group) in a randomized clinical trial', 'detailedDescription': 'This study analize the incidence of acute renal failure after performing total knee arthroplasty with or without (using local intraarticular anesthesia) use of tourniquet limb cuff (half of patients for each group) in a randomized clinical trial'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients knee arthrosis\n* Required a surgical treatment with Total Knee Arthroplasty\n\nExclusion Criteria:\n\n* Not accept to be in the study\n* Not signed consent form\n* Not having blood sample for creatinin meassure'}, 'identificationModule': {'nctId': 'NCT03795805', 'briefTitle': 'After Surgery Acute Renal Failure Incidence in Total Knee Arthroplasty With and Without Tourniquet', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Instituto Mexicano del Seguro Social'}, 'officialTitle': 'After Surgery Acute Renal Failure Incidence in Total Knee Arthroplasty With and Without Tourniquet', 'orgStudyIdInfo': {'id': 'R-2018-3401-053'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'TKA and Tourniquet', 'description': 'Total knee arthroplasty and use of tourniquet limb cuff at 270 mmHg', 'interventionNames': ['Procedure: total knee arthroplasty', 'Procedure: Tourniquet limb cuff']}, {'type': 'EXPERIMENTAL', 'label': 'Intraarticular lidocain', 'description': 'Total knee arthroplasty with Intaarticular lidocain', 'interventionNames': ['Procedure: total knee arthroplasty', 'Drug: Intaarticular lidocain']}], 'interventions': [{'name': 'total knee arthroplasty', 'type': 'PROCEDURE', 'otherNames': ['TKA'], 'description': 'Total knee arhroplasty', 'armGroupLabels': ['Intraarticular lidocain', 'TKA and Tourniquet']}, {'name': 'Tourniquet limb cuff', 'type': 'PROCEDURE', 'description': 'Tourniquet limb cuff and regular anesthesia', 'armGroupLabels': ['TKA and Tourniquet']}, {'name': 'Intaarticular lidocain', 'type': 'DRUG', 'otherNames': ['lidocaine'], 'description': '20 ml of 2% lidocain application intraarticular before surgery (intraarticular lidocain)', 'armGroupLabels': ['Intraarticular lidocain']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07020', 'city': 'Mexico City', 'country': 'Mexico', 'facility': 'UMAE Dr. Victorio de La Fuente Narvaez', 'geoPoint': {'lat': 19.42847, 'lon': -99.12766}}], 'overallOfficials': [{'name': 'Avelino Colin Vázquez, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IMSS'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'We will share only de demographic data and trial results'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto Mexicano del Seguro Social', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'JUAN LOPEZ VALENCIA', 'investigatorAffiliation': 'Instituto Mexicano del Seguro Social'}}}}