Chronic Kidney Disease(CKD), Hyperkalemia
Conditions
Keywords
Hyperkalemia, Chronic Kidney Disease, Community-Based, Non-Dialysis, Prevalence, Eaglenos POCT System
Brief summary
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.
Detailed description
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.
Interventions
OTHERNo Intervention
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.
Sponsors
Xiujuan Zang
Study design
Observational model
OTHER
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Aged 18 years or older with stable vital signs, specifically defined as: 1. Body temperature: 36.0°C-38.0°C; 2. Pulse: 50-120 beats/min; 3. Respiratory rate: 10-24 breaths/min; 4. Blood pressure: Systolic blood pressure ≥90 mmHg and diastolic blood pressure ≥60 mmHg. * Willing to participate in the study and sign the informed consent form. * Hematocrit (Hct) level between 25% and 60%. * Confirmed diagnosis of chronic kidney disease (CKD).
Exclusion criteria
* Patients in the unstable phase of acute cardiovascular or cerebrovascular diseases (e.g., acute cerebral infarction, cerebral hemorrhage, or acute coronary syndrome). * Patients in the unstable phase of severe acute diabetic complications (e.g., diabetic ketoacidosis or hyperosmolar hyperglycemic coma). * Patients currently in the acute kidney injury (AKI) stage. * Patients who have started renal replacement therapy. * Pregnant or breastfeeding women. * Patients currently participating in or who have participated in other clinical trials within the past six months. * Patients unable to understand verbal or written instructions, including informed consent content. * Patients unable to cooperate with the study procedures. * Other conditions deemed unsuitable for participation in this clinical trial by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of Hyperkalemia. | At the time of enrollment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Association Between Hyperkalemia and CKD Stage. | At the time of enrollment | 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. |
| Association Between Hyperkalemia and Blood Glucose. | At the time of enrollment | 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. |
| Association Between Hyperkalemia and Creatinine. | At the time of enrollment | 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 |
| Association Between Hyperkalemia and Age. | At the time of enrollment | 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. |
| Association Between Hyperkalemia and Hemoglobin. | At the time of enrollment | 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. |
| Performance of Hyperkalemia Prediction Model. | At the time of enrollment | 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 (%). |
| Association Between Hyperkalemia and Uric Acid. | At the time of enrollment | 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. |
Countries
China
Contacts
Primary ContactXiujuan Zang, MD
Backup ContactXiangyu Zhang, MMed
Outcome results
None listed