[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100585407":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":25,"locations":31,"responsibleParty":78,"collaborators":18,"id":80,"slug":81,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":82,"sex":88,"minAge":89,"maxAge":90,"enrollmentInfo":91,"targetDuration":18,"studyType":94,"phases":95,"briefSummary":97,"conditions":98,"keywords":100,"overallStatus":33,"whyStopped":18,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"Peking University First Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Monitoring plasma potassium using ECG device","EXPERIMENTAL","Patients in this arm will use AI-enhanced point-of-care ECG device to monitor their serum potassium level every 3 days for 6 months in addition to their regular outpatients follow-up. If ECG device detected hyperkalemia was reported, more intensive monitoring, education on diet or offer of making outpatient appointment, as appropriate, will be provided.",[13],"Device: A mobile artificial intelligence-enhanced electrocardiogram device estimating plasma potassium categories (\u003C5 mmol\u002FL, 5 - \u003C5.5 mmol\u002FL, 5.5 - \u003C6.0 mmol\u002FL and ≥ 6.0 mmol\u002FL)",{"label":15,"type":16,"description":17,"interventionNames":18},"Regular outpatients follow-up","NO_INTERVENTION","Patients in this arm will just follow their regular outpatients care without additional intervention.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DEVICE","A mobile artificial intelligence-enhanced electrocardiogram device estimating plasma potassium categories (\u003C5 mmol\u002FL, 5 - \u003C5.5 mmol\u002FL, 5.5 - \u003C6.0 mmol\u002FL and ≥ 6.0 mmol\u002FL)","A mobile AI-enhanced electrocardiogram device will be used to help patients monitor hyperkalemia. The device, shaped like a stick of chewing gum, collects time-series data of electrocardiogram lead I through two electrodes. Deep convolutional neural network algorithm can read the data and generated categories of plasma potassium (\\\u003C5 mmol\u002FL, 5 - \\\u003C5.5 mmol\u002FL, 5.5 - \\\u003C6.0 mmol\u002FL and ≥ 6.0 mmol\u002FL). Study participants receive the device after randomization. The staff establishes a WeChat group for each participant and reminds them to monitor plasma potassium every 3 days. When the detected plasma potassium category falls in 5 - \\\u003C5.5 mmol\u002FL, they will be reminded to watch diet and to verify plasma potassium again. More intensive reminding (once daily) will be sent if plasma potassium category falls in 5.5 - \\\u003C6.0 mmol\u002FL or ≥ 6.0 mmol\u002FL. An extra outpatient appointment will also be made as soon as possible for the patients when their detected plasma potassium category is ≥ 6.0 mmol\u002FL.",[9],[26],{"name":27,"role":28,"phone":29,"phoneExt":18,"email":30},"Jinwei Wang, Ph.D.","CONTACT","+86-010-83572388","wangjinwei@bjmu.edu.cn",[32,47,63],{"facility":5,"status":33,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"RECRUITING","Beijing","Beijing Municipality","100034","China","CN",{"type":40,"coordinates":41},"Point",[42,43],116.39723,39.9075,{"lat":43,"lon":42},[46],{"name":27,"role":28,"phone":29,"phoneExt":18,"email":30},{"facility":48,"status":49,"city":50,"state":51,"zip":52,"country":37,"countryCode":38,"cosmosGeoPoint":53,"geoPoint":57,"contacts":58},"The First Affiliated Hospital of Guangxi Medical University","NOT_YET_RECRUITING","Nanning","Guangxi","530021",{"type":40,"coordinates":54},[55,56],108.31667,22.81667,{"lat":56,"lon":55},[59],{"name":60,"role":28,"phone":61,"phoneExt":18,"email":62},"Ling Pan, M.D.","+86-0771-5356533","nnpanling008@sina.com",{"facility":64,"status":49,"city":65,"state":66,"zip":67,"country":37,"countryCode":38,"cosmosGeoPoint":68,"geoPoint":72,"contacts":73},"Hubei Provincial Hospital of TCM","Wuhan","Hubei","430063",{"type":40,"coordinates":69},[70,71],114.26667,30.58333,{"lat":71,"lon":70},[74],{"name":75,"role":28,"phone":76,"phoneExt":18,"email":77},"Xue Xue, M.D.","+86-027-88710029","2672754432@qq.com",{"type":79,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100585407","monitoring-hyperkalemia-using-point-of-care-ai-enabled-ecg-device-among-patients-with-chronic-kidney-disease-stages-3b-5-100585407",false,"NCT06901960","Monitoring Hyperkalemia Using Point-of-care AI-enabled ECG Device Among Patients With Chronic Kidney Disease Stages 3b-5","Monitoring Hyperkalemia Using Point-of-care AI-enabled ECG Device Among Patients With Chronic Kidney Disease Stages 3b-5 to Reduce Rate of Hyperkalemia - a Practical Randomized Clinical Trial","POCKET","Inclusion Criteria:\n\n* Patients with chronic kidney disease stages 3b-5 (eGFR: 10 - \\\u003C45 ml\u002Fmin\u002F1.73m²)\n* Patients with regular visits in the study sites to manage their chronic kidney disease (≥ 1 visit per 3 months during the past year before enrollment)\n* Willingness to participate in the study with signed informed consent\n\nExclusion Criteria:\n\n* Patients already under kidney replacement therapy or will receive kidney replacement therapy in 6 months\n* Unwillingness or without the ability to monitor hyperkalemia using the study device\n* Patients with heart pacemaker implanted","ALL","18 Years","99 Years",{"count":92,"type":93},1066,"ESTIMATED","INTERVENTIONAL",[96],"NA","The clinical trial will be conducted in a real-world outpatients setting with the goal of learning if monitoring serum potassium frequently among patients with moderate-to-advanced stages of chronic kidney disease leading to optimal management of hyperkalemia (the reduced occurrence of serum potassium ≥ 5.0 mmol\u002FL during 6 months of follow-up). It will also learn about the adherence of using a mobile monitoring device.\n\nParticipants will:\n\n* Measure their serum potassium using an AI-enhanced point-of-care ECG device at least twice per week\n* Receive health education prompts to reduce intake of potassium rich foods if their electrocardiogram device measured serum potassium is abnormal\n* Receive alerts to visit nephrology clinic if their electrocardiogram device measured serum potassium is continuously abnormal",[99],"Chronic Kidney Disease (Stages 3b-5)",[101,102,103],"Chronic kidney disease","hyperkalemia","ECG","2025-09-11",{"date":106,"type":107},"2025-09-17","ACTUAL",{"date":109,"type":107},"2025-04-02",{"date":111,"type":93},"2026-12-31",{"name":5,"class":6},3]