Prevalence and Risk Factors of Hyperkalemia in Non-Dialysis Chronic Kidney Disease Patients in Community
Prevalence and Risk Factors of Hyperkalemia in Non-Dialysis Chronic Kidney Disease Patients in a Community-Based Primary Care Setting
Xiujuan Zang
1,890 participants
Apr 28, 2025
OBSERVATIONAL
Conditions
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.
Eligibility
Inclusion Criteria8
- Aged 18 years or older with stable vital signs, specifically defined as:
- Body temperature: 36.0°C-38.0°C;
- Pulse: 50-120 beats/min;
- Respiratory rate: 10-24 breaths/min;
- 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 Criteria9
- 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.
Interventions
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.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06940414