Ignite Creation Date:
2025-12-24 @ 7:22 PM
Ignite Modification Date:
2026-01-01 @ 8:57 AM
Study NCT ID:
NCT05151003
Status:
UNKNOWN
Last Update Posted:
2023-11-29
First Post:
2021-11-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Epidemiology of In-hospital Acute Kidney Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058186', 'term': 'Acute Kidney Injury'}, {'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], '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': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003625', 'term': 'Data Collection'}], 'ancestors': [{'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-27', 'studyFirstSubmitDate': '2021-11-15', 'studyFirstSubmitQcDate': '2021-11-26', 'lastUpdatePostDateStruct': {'date': '2023-11-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acute Kidney Injury incidence', 'timeFrame': 'Collection of retrospective data from 2016', 'description': 'Rate of in-hospital Acute Kidney Injury incidence'}, {'measure': 'Acute Kidney Injury severity', 'timeFrame': 'Collection of retrospective data from 2016', 'description': 'Staging of in-hospital Acute Kidney Injury according to the KDIGO guidelines'}], 'secondaryOutcomes': [{'measure': 'Mortality in Acute Kidney Injury patients', 'timeFrame': 'Collection of retrospective data from 2016', 'description': 'Rate of in-hospital mortality among patients with Acute Kidney Injury'}, {'measure': 'Creatinine clearance after discharge', 'timeFrame': 'Collection of retrospective data from 2016', 'description': 'Data on kidney function after the discharge in Acute Kidney Injury patients'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Kidney Injury', 'Dialysis; Complications', 'Chronic Kidney Diseases']}, 'descriptionModule': {'briefSummary': 'Retrospective observational study to investigate acute kidney injury (AKI) epidemiology and outcomes in patients hospitalized in University Hospital San Martino, Genova, Italy.', 'detailedDescription': 'A retrospective observational study was designed to investigate acute kidney injury (AKI) epidemiology and outcome in patients hospitalized in University Hospital San Martino, Genova, Italy.\n\nAll data will be extracted from the hospital electronic database. The investigators will evaluate demographic, clinical and laboratory data, including age, sex, serum creatinine (sCr), sodium and electrolytes, intensive care unit (ICU) admission, length of hospital stay, death, comorbidities and primary diagnosis codes at the hospital discharge (using International Classification of Diseases-ICD-9- codes).\n\nThe investigators will include also patients affected by Coronavirus disease 19 (COVID-19).\n\nThe primary endpoint will be to describe AKI epidemiology, secondary endpoints will be to evaluate AKI-related risk factors and clinical outcomes, such as length of stay and mortality.\n\nMoreover, the investigators will describe the differences in the outcome and treatments of AKI patients in the medical wards and ICU.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients admitted to Policlinico Universitario San Martino, Genova, Italy (including those with COVID-19).', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients admitted to University Hospital San Martino, Italy\n* We'll include also patients affected by Coronavirus disease 19 (COVID-19).\n\nExclusion Criteria:\n\n* Hemodialysis patients"}, 'identificationModule': {'nctId': 'NCT05151003', 'acronym': 'GENAKI', 'briefTitle': 'Epidemiology of In-hospital Acute Kidney Injury', 'organization': {'class': 'OTHER', 'fullName': 'Universita degli Studi di Genova'}, 'officialTitle': 'Analysis of In-hospital Acute Kidney Injury Epidemiology, Treatment and Outcomes', 'orgStudyIdInfo': {'id': 'CER Liguria: 515/2020'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients admitted to University Hospital San Martino, Genova, Italy', 'description': 'Adult patients admitted to University Hospital San Martino, Genova, Italy', 'interventionNames': ['Other: Data collection']}], 'interventions': [{'name': 'Data collection', 'type': 'OTHER', 'description': 'Collection and analysis of data related to AKI epidemiology, treatment and outcomes', 'armGroupLabels': ['Patients admitted to University Hospital San Martino, Genova, Italy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Genova', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Pasquale Esposito, Prof', 'role': 'CONTACT', 'email': 'pasquale.esposito@unige.it', 'phone': '00390105557162'}, {'name': 'Pasquale Esposito', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Francesca Viazzi', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'IRCCS Policlinico San Martino', 'geoPoint': {'lat': 45.21604, 'lon': 11.87211}}], 'centralContacts': [{'name': 'Pasquale Esposito', 'role': 'CONTACT', 'email': 'pasquale.esposito@unige.it', 'phone': '00390105555362'}], 'overallOfficials': [{'name': 'Pasquale Esposito, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Genova, Italy'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Patient data will be anonymized.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universita degli Studi di Genova', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ospedale Policlinico San Martino', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Nephrology', 'investigatorFullName': 'Pasquale Esposito', 'investigatorAffiliation': 'Universita degli Studi di Genova'}}}}