[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100585407":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":25,"locations":31,"responsibleParty":77,"collaborators":18,"id":79,"slug":18,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":80,"sex":86,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":18,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":98,"overallStatus":33,"whyStopped":18,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"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",[32,46,62],{"facility":5,"status":33,"city":34,"state":35,"zip":36,"country":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"RECRUITING","Beijing","Beijing Municipality","100034","China",{"type":39,"coordinates":40},"Point",[41,42],116.39723,39.9075,{"lat":42,"lon":41},[45],{"name":27,"role":28,"phone":29,"phoneExt":18,"email":30},{"facility":47,"status":48,"city":49,"state":50,"zip":51,"country":37,"cosmosGeoPoint":52,"geoPoint":56,"contacts":57},"The First Affiliated Hospital of Guangxi Medical University","NOT_YET_RECRUITING","Nanning","Guangxi","530021",{"type":39,"coordinates":53},[54,55],108.31667,22.81667,{"lat":55,"lon":54},[58],{"name":59,"role":28,"phone":60,"phoneExt":18,"email":61},"Ling Pan, M.D.","+86-0771-5356533","nnpanling008@sina.com",{"facility":63,"status":48,"city":64,"state":65,"zip":66,"country":37,"cosmosGeoPoint":67,"geoPoint":71,"contacts":72},"Hubei Provincial Hospital of TCM","Wuhan","Hubei","430063",{"type":39,"coordinates":68},[69,70],114.26667,30.58333,{"lat":70,"lon":69},[73],{"name":74,"role":28,"phone":75,"phoneExt":18,"email":76},"Xue Xue, M.D.","+86-027-88710029","2672754432@qq.com",{"type":78,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","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":90,"type":91},1066,"ESTIMATED","INTERVENTIONAL",[94],"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",[97],"Chronic Kidney Disease (Stages 3b-5)",[99,100,101],"Chronic kidney disease","hyperkalemia","ECG","2025-09-11",{"date":104,"type":105},"2025-09-17","ACTUAL",{"date":107,"type":105},"2025-04-02",{"date":109,"type":91},"2026-12-31",{"name":5,"class":6},3]