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Prevalence and Risk Factors of Hyperkalemia in Non-Dialysis Chronic Kidney Disease Patients in Community

ConditionsHyperkalemiaChronic Kidney Disease(CKD)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorXiujuan Zang

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

Non-dialysis CKD patients (Stage 1-5), aged 18 years or older, recruited from 18 community health centers in Songjiang District, Shanghai.

Trial design

Design model

Other

Time perspective

Cross-sectional

Treatments tested in this trial

  • No Intervention

    Other 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.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Prevalence 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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Xiujuan Zang

Lead sponsor

Songjiang Hospital Affiliated to Shanghai Jiaotong University School of Medicine

Sponsor institution

Source ClinicalTrials.gov
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