Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2026-02-22 @ 6:58 PM
Study NCT ID:
NCT02793167
Status:
COMPLETED
Last Update Posted:
2023-02-23
First Post:
2016-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Values of Automated Electronic Alert for Acute Kidney Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058186', 'term': 'Acute Kidney Injury'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2000}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2022-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-21', 'studyFirstSubmitDate': '2016-05-23', 'studyFirstSubmitQcDate': '2016-06-07', 'lastUpdatePostDateStruct': {'date': '2023-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse events during hospitalization', 'timeFrame': 'from start of AKI to discharge,up to 4 weeks', 'description': 'cardiac shock/ need for intensive care/ cardiopulmonary resuscitation/ cardiac death/ death'}, {'measure': 'Incidence of cardiovascular disease and its occurrence time followed up for 1 years', 'timeFrame': 'One year after discharge', 'description': 'heart failure/ acute coronary syndrome/ readmission/cardiac readmission/ cardiovascular intervention or surgery'}, {'measure': 'The AKI outcome and its occurrence time followed up for 1 years', 'timeFrame': 'One year after discharge', 'description': 'AKI recovery/stop renal replacement therapy'}, {'measure': 'AKI recovery/stop renal replacement therapy', 'timeFrame': 'from start of AKI to discharge,up to 4 weeks', 'description': 'Glomerular filtration rate decreased/ new occurrence proteinuria/ original proteinuria aggravation'}], 'secondaryOutcomes': [{'measure': 'Proportion of nephrology referral', 'timeFrame': 'from start of AKI to discharge,up to 4 weeks'}, {'measure': 'Diagnostic rate of AKI at discharge', 'timeFrame': 'from start of AKI to discharge,up to 4 weeks'}, {'measure': 'Follow-up rate after discharge', 'timeFrame': 'One year after discharge'}]}, 'conditionsModule': {'keywords': ['acute kidney injury', 'medication alert systems'], 'conditions': ['Acute Kidney Injury']}, 'descriptionModule': {'briefSummary': 'Acute kidney injury (AKI) is common, serious and expensive.It is associated with significant mortality, morbidity and increased length of hospital stay.To improve clinical outcomes of AKI by early detection and timely referral to the renal,the investigators developed an electronic alert system which identifies all cases of AKI occurring in patients over 18 years.The system was also designed to collect data on AKI incidence one of the biggest tertiary hospital in China.', 'detailedDescription': 'A prospective, randomly controlled cohort study will be conducted agmong the patients with AKI who are detected by the use of AKI sniffer. The investigators chose to assess all inpatient serum creatinine results using a combination of "KDIGO" criteria.\n\nThe investigators randomly divided the patients into two groups:\n\n1. Usual care : patients will receive standard clinical care by the primary physicians\n2. AKI alert : an AKI alert will be sent to the the doctor in charge. Our team of kidney experts would give a suggestion if the the doctor in charge issue consultation applications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients with an Alert for AKI(based on KDIGO guidelines)\n\nExclusion Criteria:\n\n* patients already on dialysis for AKI at the time of alert\n* patients with End stage renal disease\n* patients \\<18 years of age\n* patients dissenting from participation according to the Ethics application'}, 'identificationModule': {'nctId': 'NCT02793167', 'briefTitle': 'Clinical Values of Automated Electronic Alert for Acute Kidney Injury', 'organization': {'class': 'OTHER', 'fullName': "Guangdong Provincial People's Hospital"}, 'officialTitle': 'Clinical Values of Automated Electronic Alert for Acute Kidney injury-a Prospective ,Randomly Controlled Cohort Study', 'orgStudyIdInfo': {'id': 'GGH2016-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Usual care', 'description': 'patients will receive standard clinical care by the doctor in charge.'}, {'type': 'EXPERIMENTAL', 'label': 'AKI alert', 'description': 'an AKI alert will send to the the doctor in charge.Our team of nephrologists would give suggestions if the doctor in charge issue consultation application.', 'interventionNames': ['Device: AKI alert']}], 'interventions': [{'name': 'AKI alert', 'type': 'DEVICE', 'armGroupLabels': ['AKI alert']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Nephrology Dept,Guangdong General Hospital', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'XinLing Liang', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Director of Blood Purification Center of Guangdong General Hospital', 'investigatorFullName': 'XinLing Liang', 'investigatorAffiliation': "Guangdong Provincial People's Hospital"}}}}