Ignite Creation Date:
2025-12-25 @ 1:24 AM
Ignite Modification Date:
2025-12-27 @ 11:48 PM
Study NCT ID:
NCT07089693
Status:
COMPLETED
Last Update Posted:
2025-07-28
First Post:
2025-07-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acute Kidney Injury in Critical COVID-19: Outcomes and Risks
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D058186', 'term': 'Acute Kidney Injury'}], 'ancestors': [{'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'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': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 238}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2022-08-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-22', 'studyFirstSubmitDate': '2025-07-21', 'studyFirstSubmitQcDate': '2025-07-22', 'lastUpdatePostDateStruct': {'date': '2025-07-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intensive care unit mortality', 'timeFrame': 'From ICU admission until in-hospital death or ICU discharge, whichever occurs first, assessed up to 90 days.', 'description': 'To evaluate whether the development of AKI is associated with mortality in COVID-19 patients monitored in the intensive care unit.'}], 'secondaryOutcomes': [{'measure': 'Length of intensive care unit stay', 'timeFrame': 'From ICU admission until ICU discharge, assessed up to 12 months.', 'description': 'To assess whether the development of AKI in COVID-19 patients is associated with the length of stay in the intensive care unit.'}, {'measure': 'Incidence of acute kidney injury', 'timeFrame': 'From ICU admission until AKI diagnosis or ICU discharge, whichever occurs first, assessed during hospitalization (up to 100 days).', 'description': 'To determine the incidence of AKI among COVID-19 patients, defined by the KDIGO criteria.'}, {'measure': 'Association between patient characteristics and AKI development', 'timeFrame': 'From ICU admission until AKI diagnosis or ICU discharge, assessed up to 100 days.', 'description': 'To identify clinical and laboratory predictors associated with AKI development in COVID-19 patients requiring intensive care, using retrospective data analysis.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19', 'acute kidney injury', 'intensive care unit', 'risk factors', 'incidence'], 'conditions': ['COVID -19', 'Acute Kidney Injury', 'Intensive Care Unit (ICU) Admission', 'Mortality']}, 'referencesModule': {'references': [{'pmid': '32191259', 'type': 'BACKGROUND', 'citation': 'Arentz M, Yim E, Klaff L, Lokhandwala S, Riedo FX, Chong M, Lee M. Characteristics and Outcomes of 21 Critically Ill Patients With COVID-19 in Washington State. JAMA. 2020 Apr 28;323(16):1612-1614. doi: 10.1001/jama.2020.4326.'}, {'pmid': '38549280', 'type': 'BACKGROUND', 'citation': 'Ratnayake A, Sarnowski A, Sinclair F, Annear NMP, Banerjee D, Chis Ster I. The dynamics and outcomes of AKI progression during the COVID-19 pandemic. Nephrology (Carlton). 2024 Jun;29(6):325-337. doi: 10.1111/nep.14297. Epub 2024 Mar 28.'}, {'pmid': '39839732', 'type': 'BACKGROUND', 'citation': 'Guissouma J, Ben Ali H, Allouche H, Trabelsi I, Hammami O, Yahia Y, Hatem G. Acute Kidney Injury Complicating Critical Forms of COVID-19: risk Factors and Prognostic Impact. F1000Res. 2025 Jan 2;13:497. doi: 10.12688/f1000research.144105.3. eCollection 2024.'}, {'pmid': '38407862', 'type': 'BACKGROUND', 'citation': "Aklilu AM, Kumar S, Nugent J, Yamamoto Y, Coronel-Moreno C, Kadhim B, Faulkner SC, O'Connor KD, Yasmin F, Greenberg JH, Moledina DG, Testani JM, Wilson FP. COVID-19-Associated Acute Kidney Injury and Longitudinal Kidney Outcomes. JAMA Intern Med. 2024 Apr 1;184(4):414-423. doi: 10.1001/jamainternmed.2023.8225."}]}, 'descriptionModule': {'briefSummary': 'This retrospective observational study aims to determine the incidence of acute kidney injury (AKI) associated with COVID-19, risk factors, and effects on mortality for intensive care unit patients. Data from 238 COVID-19 patients monitored in the Anesthesiology and Reanimation Intensive Care Unit of Ankara University Ibni Sina Hospital between January 1, 2021 and January 1, 2022 were retrospectively reviewed. Patients were divided into two groups according to the level of renal damage (with and without AKI). Those with AKI were staged per the KDIGO criteria (Stage 1-2-3). Demographic data, comorbidities, Charlson comorbidity indexes, Acute Physiology and Chronic Health Evaluation scores, laboratory results, and mortality data were examined. The data obtained were compared between the groups.\n\nThe findings may help improve clinical awareness and guide management strategies in intensive care unit patients with COVID-19 at risk of AKI', 'detailedDescription': 'This retrospective, single-center observational study was conducted at Ankara University Hospital. Data from 238 COVID-19 patients monitored in the Anesthesiology and Reanimation Intensive Care Unit of Ankara University Ibni Sina Hospital between January 1, 2021 and January 1, 2022 were retrospectively reviewed. The objective of the study was to investigate the frequency, risk factors, and impact on mortality of acute kidney injury (AKI) in adult patients hospitalized with confirmed COVID-19 infection.\n\nPatients with a confirmed diagnosis of COVID-19 and available renal function data were included in the analysis. AKI was defined and staged according to the Kidney Disease: Improving Global Outcomes (KDIGO) criteria. Demographic characteristics, comorbidities, laboratory values, and clinical parameters were evaluated to identify potential risk factors for AKI development. The relationship between the presence and severity of AKI and in-hospital mortality was assessed.\n\nThe study aims to provide insight into the burden of COVID-19-associated AKI and to support improved clinical decision-making for identifying and managing high-risk patients in hospital settings.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients (aged 18 and older) with PCR-confirmed COVID-19 who were admitted to the intensive care unit (ICU) at Ankara University Hospital between January 1,2021 and January 1,2022. All patients had available records and remained in the ICU for at least 48 hours.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years or older\n* Hospitalized patients with COVID-19 confirmed by PCR test\n* Required follow-up in the intensive care unit between January 1, 2021 and January 1, 2022\n\nExclusion Criteria:\n\n* Patients with end-stage renal disease (ESRD)\n* History of renal transplantation\n* Intensive care unit stay shorter than 48 hours'}, 'identificationModule': {'nctId': 'NCT07089693', 'briefTitle': 'Acute Kidney Injury in Critical COVID-19: Outcomes and Risks', 'organization': {'class': 'OTHER', 'fullName': 'Ankara University'}, 'officialTitle': 'Determination of Risk Factors, Incidence and Mortality Rates of Acute Kidney Injury in COVID-19 Patients Hospitalized in Intensive Care Unit', 'orgStudyIdInfo': {'id': 'İ05-257-22'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'non-AKI'}, {'label': 'stage 1 AKI'}, {'label': 'stage 2 AKI'}, {'label': 'stage 3 AKI'}]}, 'contactsLocationsModule': {'locations': [{'zip': '06230', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Ankara University', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'Gizem Kahraman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ankara University Department of Anesthesiology and Reanimation'}, {'name': 'Mustafa Kemal Bayar, Prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ankara University Department of Anesthesiology and Reanimation'}, {'name': 'Pınar Karabak Bilal, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ankara University Department of Anesthesiology and Reanimation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, Intensive Care Specialist', 'investigatorFullName': 'Pınar KARABAK BİLAL', 'investigatorAffiliation': 'Ankara University'}}}}