Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2026-02-23 @ 1:11 AM
Study NCT ID:
NCT03736304
Status:
COMPLETED
Last Update Posted:
2024-01-02
First Post:
2018-11-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Automated Electronic Alert for Acute Kidney Injury on the Outcomes of Hospitalized Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058186', 'term': 'Acute Kidney Injury'}, {'id': 'D004194', 'term': 'Disease'}], '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': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'All study investigators and participants were blinded to patients randomization status.'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4536}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2022-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-28', 'studyFirstSubmitDate': '2018-11-08', 'studyFirstSubmitQcDate': '2018-11-08', 'lastUpdatePostDateStruct': {'date': '2024-01-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Estimated glomerular filtration rate changed within 7 days', 'timeFrame': 'within 7 days diagnosed with AKI', 'description': 'Medical record'}], 'secondaryOutcomes': [{'measure': 'seven-day mortality', 'timeFrame': 'within 7 days diagnosed with AKI', 'description': 'Medical record'}, {'measure': '30-day mortality', 'timeFrame': 'within 30 days diagnosed with AKI', 'description': 'Medical record'}, {'measure': '1-year mortality', 'timeFrame': 'within 1 year diagnosed with AKI', 'description': 'telephone follow-up'}, {'measure': 'receiving renal replacement therapy at seventh day', 'timeFrame': '7 days', 'description': 'Medical record'}, {'measure': 'receiving renal replacement therapy at 30th day', 'timeFrame': '30 days', 'description': 'telephone follow-up'}, {'measure': 'receiving renal replacement therapy at 1 year', 'timeFrame': '1 year', 'description': 'telephone follow-up'}, {'measure': 'the rate of stage 2 AKI', 'timeFrame': 'within 7 days diagnosed with AKI', 'description': 'Medical record'}, {'measure': 'the rate of stage 3 AKI', 'timeFrame': 'within 7 days diagnosed with AKI', 'description': 'Medical record'}, {'measure': 'the rate of AKI recovery at 90 day', 'timeFrame': '90 days', 'description': 'telephone follow-up'}, {'measure': 'the rate of timely-recognition of AKI', 'timeFrame': '3 days', 'description': 'Medical record'}, {'measure': 'the interventions for AKI', 'timeFrame': 'within 7 days diagnosed with AKI', 'description': 'Medical record'}, {'measure': 'Follow-up rate after discharge', 'timeFrame': '1 year', 'description': 'telephone follow-up'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Kidney Injury', 'Outcomes', 'Early Diagnosis']}, 'referencesModule': {'references': [{'pmid': '30310097', 'type': 'BACKGROUND', 'citation': 'Wu B, Li L, Cheng X, Yan W, Liu Y, Xing C, Mao H. Propensity-score-matched evaluation of under-recognition of acute kidney injury and short-term outcomes. Sci Rep. 2018 Oct 11;8(1):15171. doi: 10.1038/s41598-018-33103-9.'}, {'pmid': '26466051', 'type': 'BACKGROUND', 'citation': 'Yang L, Xing G, Wang L, Wu Y, Li S, Xu G, He Q, Chen J, Chen M, Liu X, Zhu Z, Yang L, Lian X, Ding F, Li Y, Wang H, Wang J, Wang R, Mei C, Xu J, Li R, Cao J, Zhang L, Wang Y, Xu J, Bao B, Liu B, Chen H, Li S, Zha Y, Luo Q, Chen D, Shen Y, Liao Y, Zhang Z, Wang X, Zhang K, Liu L, Mao P, Guo C, Li J, Wang Z, Bai S, Shi S, Wang Y, Wang J, Liu Z, Wang F, Huang D, Wang S, Ge S, Shen Q, Zhang P, Wu L, Pan M, Zou X, Zhu P, Zhao J, Zhou M, Yang L, Hu W, Wang J, Liu B, Zhang T, Han J, Wen T, Zhao M, Wang H; ISN AKF 0by25 China Consortiums. Acute kidney injury in China: a cross-sectional survey. Lancet. 2015 Oct 10;386(10002):1465-71. doi: 10.1016/S0140-6736(15)00344-X.'}, {'pmid': '25726515', 'type': 'BACKGROUND', 'citation': 'Wilson FP, Shashaty M, Testani J, Aqeel I, Borovskiy Y, Ellenberg SS, Feldman HI, Fernandez H, Gitelman Y, Lin J, Negoianu D, Parikh CR, Reese PP, Urbani R, Fuchs B. Automated, electronic alerts for acute kidney injury: a single-blind, parallel-group, randomised controlled trial. Lancet. 2015 May 16;385(9981):1966-74. doi: 10.1016/S0140-6736(15)60266-5. Epub 2015 Feb 26.'}, {'pmid': '38241047', 'type': 'DERIVED', 'citation': 'Li T, Wu B, Li L, Bian A, Ni J, Liu K, Qin Z, Peng Y, Shen Y, Lv M, Lu X, Xing C, Mao H. Automated Electronic Alert for the Care and Outcomes of Adults With Acute Kidney Injury: A Randomized Clinical Trial. JAMA Netw Open. 2024 Jan 2;7(1):e2351710. doi: 10.1001/jamanetworkopen.2023.51710.'}]}, 'descriptionModule': {'briefSummary': 'Acute kidney injury (AKI) is a common disease, but diagnosis is usually delayed or missed in hospitalized patients. The automated electronic alert for AKI may help to improve the outcomes of these patients through identifying all cases of AKI early. Therefore, the investigators conduct a randomly controlled study to test whether automated electronic alert for AKI could improve the outcomes of hospitalized patients.', 'detailedDescription': 'Acute kidney injury (AKI) is a common disease, but diagnosis is usually delayed or missed in hospitalized patients. The automated electronic alert for AKI may help to improve the outcomes of these patients through identifying all cases of AKI early. Therefore, the investigators conduct a randomly controlled study to test whether automated electronic alert for AKI could improve the outcomes of hospitalized patients.\n\nThe patients were randomly divided into two groups:\n\nUsual care : patients will receive standard clinical care by the primary physicians AKI alert : an AKI alert will be sent to the doctor in charge. The team of kidney experts would give a suggestion if the doctor in charge need a renal consultation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hospitalized adult patients with an Alert for AKI(based on KDIGO guidelines)\n\nExclusion Criteria:\n\n* Patients already having eGFR\\<15ml/min/1.73m2 or receiving renal replacement therapy for AKI at the time of alert.\n* Patients already having a AKI before admission.'}, 'identificationModule': {'nctId': 'NCT03736304', 'briefTitle': 'The Effect of Automated Electronic Alert for Acute Kidney Injury on the Outcomes of Hospitalized Patients', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital with Nanjing Medical University'}, 'officialTitle': 'The Effect of Automated Electronic Alert for Acute Kidney Injury on the Outcomes of Hospitalized Patients: a Single Center Randomized Controlled Trial.', 'orgStudyIdInfo': {'id': '2018-SR-180'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Usual care', 'description': 'Patients will receive standard clinical care by the doctor in charge.', 'interventionNames': ['Other: Usual care']}, {'type': 'EXPERIMENTAL', 'label': 'AKI alert', 'description': 'An AKI alert will send to the the doctor in charge. The team of nephrologists would give suggestions if the doctor in charge need a renal consultation.', 'interventionNames': ['Device: AKI alert']}], 'interventions': [{'name': 'AKI alert', 'type': 'DEVICE', 'description': 'An AKI alert will send to the doctor in charge. The team of nephrologists would give suggestions if the doctor in charge need a renal consultation.', 'armGroupLabels': ['AKI alert']}, {'name': 'Usual care', 'type': 'OTHER', 'description': 'Patients will receive standard clinical care by the doctor in charge.', 'armGroupLabels': ['Usual care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '210029', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Jiangsu Province Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'overallOfficials': [{'name': 'Huijuan Mao, PhD,MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Nephrology, The First Affiliated Hospital of Nanjing Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital with Nanjing Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}