Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2025-12-25 @ 11:18 PM
Study NCT ID:
NCT06902493
Status:
COMPLETED
Last Update Posted:
2025-03-30
First Post:
2025-03-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of Prior SGLT2 Inhibitors Use on the Development and Progression of Sepsis-Associated Acute Kidney Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D012772', 'term': 'Shock, Septic'}, {'id': 'D058186', 'term': 'Acute Kidney Injury'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012769', 'term': 'Shock'}, {'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 664}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-28', 'studyFirstSubmitDate': '2025-03-19', 'studyFirstSubmitQcDate': '2025-03-28', 'lastUpdatePostDateStruct': {'date': '2025-03-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Odds of sepsis-associated acute kidney injury (AKI) in patients with prior use of SGLT2 inhibitors (SGLT2i)', 'timeFrame': 'The exposure window for SGLT2i use will be defined as any use within 90 days prior to the onset of sepsis. The outcome (sepsis-associated AKI) will be evaluated during the index hospitalization for sepsis.', 'description': 'The primary outcome is to determine whether prior use of SGLT2 inhibitors is associated with a reduced odds of developing sepsis-associated AKI. This will be assessed by comparing the frequency of AKI among patients with sepsis who were exposed to SGLT2i prior to hospitalization (cases) versus those who were not exposed (controls).'}], 'secondaryOutcomes': [{'measure': 'ICU length of stay', 'timeFrame': 'During ICU stay (from ICU admission to discharge), Maximum 6 months stay', 'description': 'The number of days of ICU stay'}, {'measure': 'The need for RRT', 'timeFrame': 'During ICU stay (from ICU admission to discharge), Maximum 6 months stay', 'description': 'The prevalence of RRT during ICU stay'}, {'measure': '28-day mortality', 'timeFrame': 'Up to day-28 from ICU admission', 'description': 'The mortality rate at day 28 in ICU'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sepsis', 'Acute Kidney Injury', 'Sepsis-associated acute kidney injury', 'SGLT2i'], 'conditions': ['Sepsis', 'Septic Shock', 'Acute Kidney Injury']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to investigate whether using SGLT2i may be associated with decreased incidence of sepsis-induced AKI or not.', 'detailedDescription': 'The primary objective of this study is to investigate whether using SGLT2i may be associated with decreased incidence of sepsis-induced AKI or not.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All adult (≥ 18 year) patients who were admitted to ICU with sepsis syndromes (sepsis or septic shock), according to sepsis-3 definition.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All adult (≥ 18 year) patients who were admitted to ICU with sepsis syndromes (sepsis or septic shock), according to sepsis-3 definition.\n\nExclusion Criteria:\n\n* Missing data\n* Renal transplant or tumor\n* Solitary kidney\n* Established CKD\n* Obstructive uropathy\n* Renal artery stenosis\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT06902493', 'briefTitle': 'Impact of Prior SGLT2 Inhibitors Use on the Development and Progression of Sepsis-Associated Acute Kidney Injury', 'organization': {'class': 'OTHER_GOV', 'fullName': 'University of Jazan'}, 'officialTitle': 'Impact of Prior Sodium-Glucose Co-Transporter 2 Inhibitor Use on the Development and Progression of Sepsis-Associated Acute Kidney Injury', 'orgStudyIdInfo': {'id': 'SGLT2I-AKI'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'SA-AKI Group', 'description': 'Patients diagnosed with sepsis syndromes (sepsis or septic shock) and AKI according to sepsis-3 definition and KDIGO criteria, respectively', 'interventionNames': ['Other: No intervention']}, {'label': 'No AKI group', 'description': 'Patients diagnosed with sepsis syndromes (sepsis or septic shock) and AKI according to sepsis-3 definition', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'No intervention', 'armGroupLabels': ['No AKI group', 'SA-AKI Group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Al ‘Usaylah', 'country': 'Saudi Arabia', 'facility': 'King Fahd Central Hospital', 'geoPoint': {'lat': 16.92028, 'lon': 42.73528}}], 'overallOfficials': [{'name': 'Mohammed Alshrahili, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Armed Forces Hospitals, Southern Region, Saudi Arabia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Jazan', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Pharmaceutics', 'investigatorFullName': 'Ahmad Abdullah Salawi', 'investigatorAffiliation': 'University of Jazan'}}}}