The goal of this observational study is to investigate the prevalence and risk factors of hyperkalemia in community-based non-dialysis chronic kidney disease (CKD) patients. The main questions it aims to answer are: 1. What is the prevalence of hyperkalemia in non-dialysis CKD patients in a primary care setting? 2. What are the key risk factors influencing the occurrence of hyperkalemia in this population? Researchers will collect clinical and demographic data from participants across 18 community health centers and use both point-of-care testing (POCT) and laboratory-based methods to measure serum potassium levels and related parameters. Participants will: 1. Provide blood samples for POCT and laboratory testing. 2. Participate in interviews or questionnaires to gather clinical and lifestyle information. The findings will be used to construct a risk prediction model for hyperkalemia, aiming to optimize screening pathways and improve disease management strategies in primary care.
Hyperkalemia is a common and life-threatening complication in CKD, with limited data available for non-dialysis patients in community settings. This cross-sectional study will enroll 2,000 non-dialysis CKD patients (Stages 1-5) from 18 community health centers in Songjiang, Shanghai. The study includes: 1. Validation phase: 500 participants to validate POCT devices for measuring whole blood potassium, glucose, creatinine, uric acid, and hemoglobin. 2. Main phase: 1,500 participants to assess hyperkalemia prevalence and risk factors. Data will be collected through: 1. POCT and laboratory testing of blood samples. 2. Structured questionnaires capturing demographics, comorbidities, and lifestyle factors. Statistical analyses will identify key risk factors, and a predictive model will be developed to guide early screening and intervention. This study aims to improve CKD management in primary care by providing evidence for targeted hyperkalemia screening and prevention strategies.
Study Type
OBSERVATIONAL
Enrollment
1,890
This is an observational study with no interventions. POCT devices, provided by Eaglenos Sciences, Inc., are used to measure blood glucose, creatinine, uric acid, hemoglobin, and potassium levels in non-dialysis CKD patients for data collection purposes only.
Songjiang Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China
RECRUITINGPrevalence of Hyperkalemia.
The proportion of non-dialysis CKD patients with hyperkalemia, defined as a blood potassium level greater than 5.0 mmol/L, measured using point-of-care testing (POCT) at enrollment.
Time frame: At the time of enrollment
Association Between Hyperkalemia and Age.
Evaluates the association between hyperkalemia (blood potassium \> 5.0 mmol/L) and age (years) in non-dialysis CKD patients at enrollment, reported as odds ratios from univariate and multivariate logistic regression analyses.
Time frame: At the time of enrollment
Association Between Hyperkalemia and CKD Stage.
Evaluates the association between hyperkalemia (blood potassium \> 5.0 mmol/L) and CKD stage (1-5) in non-dialysis CKD patients at enrollment, reported as odds ratios from univariate and multivariate logistic regression analyses.
Time frame: At the time of enrollment
Association Between Hyperkalemia and Blood Glucose.
Evaluates the association between hyperkalemia (blood potassium \> 5.0 mmol/L) and blood glucose (mmol/L) in non-dialysis CKD patients using POCT at enrollment, reported as odds ratios from univariate and multivariate logistic regression analyses.
Time frame: At the time of enrollment
Association Between Hyperkalemia and Creatinine.
Evaluates the association between hyperkalemia (blood potassium \> 5.0 mmol/L) and creatinine (μmol/L) in non-dialysis CKD patients using POCT at enrollment, reported as odds ratios from univariate and multivariate logistic regression analyses
Time frame: At the time of enrollment
Association Between Hyperkalemia and Uric Acid.
Evaluates the association between hyperkalemia (blood potassium \> 5.0 mmol/L) and uric acid (μmol/L) in non-dialysis CKD patients using POCT at enrollment, reported as odds ratios from univariate and multivariate logistic regression analyses.
Time frame: At the time of enrollment
Association Between Hyperkalemia and Hemoglobin.
Evaluates the association between hyperkalemia (blood potassium \> 5.0 mmol/L) and hemoglobin (g/L) in non-dialysis CKD patients using POCT at enrollment, reported as odds ratios from univariate and multivariate logistic regression analyses.
Time frame: At the time of enrollment
Performance of Hyperkalemia Prediction Model.
Assesses the performance of a hyperkalemia prediction model in non-dialysis CKD patients using data from enrollment, reported as area under the ROC curve (AUC), sensitivity (%), and specificity (%).
Time frame: At the time of enrollment
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